A pill soup combination for treating advanced gastric cancer and application thereof

Abstract

The present application relates to a kind of pharmaceutical composition for treating advanced gastric cancer, in particular, the pharmaceutical composition of pill soup stacking medicine method.The composition includes radix astragali, pungent turmeric, radix comphorae etc.Ingredients are mixed into decoction according to specific proportion, combined with Xi Huang pill and apatinib.The decoction has the effect of strengthening body resistance and consolidating foundation, while the pill is mainly used to attack and remove the metastasis into collaterals, and remove stasis and toxicant to eliminate mass.A series of clinical cases verify that the therapy shows significant efficacy on patients with advanced gastric cancer, and no serious adverse reactions are found.

Description

Technical Field

[0001] This invention relates to a drug for treating advanced gastric cancer and its application. Background Technology

[0002] Advanced gastric cancer poses a serious threat to public health. Statistics released by the National Cancer Center in 2022 show that gastric cancer ranks fourth in new cases and third in deaths among malignant tumors in my country, with 480,000 new cases and 370,000 deaths. Gastric cancer in my country is characterized by late TNM (the internationally recognized tumor staging system), high tumor burden, strong tumor heterogeneity, and poor overall prognosis, with a 5-year overall survival rate of only 35.1%. Among these, newly diagnosed advanced gastric cancer patients account for 23%, with a 5-year survival rate of only 9.4%. Traditional chemotherapy for advanced gastric cancer is ineffective. In recent years, the combined use of new drugs (targeted therapies, immunotherapy, etc.) has significantly prolonged the survival of patients receiving first- and second-line treatment. However, third-line treatment for advanced gastric cancer has long been a challenge in clinical practice, with limited efficacy and poor patient compliance.

[0003] Current guidelines and related studies indicate that the options for third-line treatment of advanced gastric cancer should be differentiated based on the expression status of Her-2 (human epidermal growth factor receptor 2): For Her-2 positive patients, the DESTINY-astric06 study of trastuzumab and the C008 study of vedicetuzumab can be referenced, with corresponding median progression-free survival (PFS) of 5.7 months and 4.1 months, and median overall survival (OS) of 10.2 months and 7.6 months, respectively. The main adverse reactions include myelosuppression and interstitial lung disease, and patients have relatively poor tolerance to these conditions. For Her-2 negative patients, the regimens from the phase III clinical trials of apatinib and the ATTRACTION-2 clinical trial of nivolumab can be used, with corresponding median PFS of 2.6 months and 1.61 months, and median OS of 6.5 months and 5.26 months, respectively.

[0004] In summary, patients with advanced gastric cancer still face the dilemma of limited treatment efficacy, short survival time, and difficulty in improving quality of life, especially Her-2 negative patients, whose prognosis is even worse. Summary of the Invention

[0005] In view of this, the purpose of this invention is to provide a pill-and-decoction combination for the treatment of advanced gastric cancer and its application, which is suitable for third-line treatment of advanced gastric cancer, prolongs the survival of patients, and improves their quality of life.

[0006] To achieve the above-mentioned objectives, the present invention employs the following technical solution: A pill-decoction stacked medicine composition for treating advanced gastric cancer, comprising a traditional Chinese medicine decoction, a traditional Chinese medicine pill, and a gastric cancer targeted drug; the traditional Chinese medicine decoction is composed of the following components in parts by weight: 25-35 parts of Astragalus membranaceus, 15-30 parts of Rhizoma Curcumae, 10-18 parts of Codonopsis pilosula, 8-12 parts of Rhizoma Sparganii, 12-18 parts of Poria cocos, 25-35 parts of Actinidia chinensis Planch., 12-20 parts of Atractylodes macrocephala Koidz. stir-fried with bran, 10-15 parts of Pinellia ternata processed with ginger, 5-8 parts of Citrus reticulata Blanco, 4-6 parts of Coridius chinensis sautéed with wine, 12-18 parts of Paeonia lactiflora Pall. stir-fried, 8-13 parts of Angelica sinensis sautéed with wine, 5-9 parts of Aucklandia lappa Decne. stir-fried, 16-25 parts of Coix lacryma-jobi L., 4-7 parts of Amomum villosum Lour., 3-6 parts of Glycyrrhiza glabra L. honey-roasted; the traditional Chinese medicine pill is Xihuang Pills.

[0007] Preferably, the gastric cancer targeted drug is Apatinib Mesylate Tablets.

[0008] Preferably, the traditional Chinese medicine decoction is composed of the following components in parts by weight: 30 parts of Astragalus membranaceus, 30 parts of Rhizoma Curcumae, 15 parts of Codonopsis pilosula, 10 parts of Rhizoma Sparganii, 15 parts of Poria cocos, 30 parts of Actinidia chinensis Planch., 15 parts of Atractylodes macrocephala Koidz. stir-fried with bran, 12 parts of Pinellia ternata processed with ginger, 6 parts of Citrus reticulata Blanco, 5 parts of Coridius chinensis sautéed with wine, 15 parts of Paeonia lactiflora Pall. stir-fried, 10 parts of Angelica sinensis sautéed with wine, 6 parts of Aucklandia lappa Decne. stir-fried, 20 parts of Coix lacryma-jobi L., 5 parts of Amomum villosum Lour., 5 parts of Glycyrrhiza glabra L. honey-roasted.

[0009] Use of the said composition in the preparation of a drug for treating advanced gastric cancer.

[0010] Clinically, for third-line treatment of advanced cancer patients, small molecule anti-angiogenic drugs such as Apatinib (for gastric cancer), Anlotinib (for lung cancer), and Fruquintinib (for colorectal cancer) are often orally administered to inhibit the formation of new tumor blood vessels and improve the tumor microenvironment. Their functions are similar to those of traditional Chinese medicines for promoting qi and dredging collaterals, and removing blood stasis and resolving masses, especially insect drugs. Therefore, based on evidence-based medicine evidence and medical ethics requirements, when using the "combined treatment - pill-decoction stacked medicine method" to differentiate and treat advanced cancer, small molecule targeted drugs can be selected to replace some anti-cancer and mass-resolving traditional Chinese medicine pills, and combined with traditional Chinese medicine decoctions to form a pill-decoction stacked medicine plan.

[0011] Compatibility of monarch, minister, assistant, and envoy: Using Xiangsha Liujunzi Decoction to strengthen the spleen and stomach, resolve phlegm and dampness, and regulate qi movement as the monarch, laying the foundation for strengthening the healthy qi and consolidating the root; Angelica sinensis sautéed with wine and Paeonia lactiflora Pall. stir-fried nourish the liver and soothe the liver, protect the stomach yin, so that the liver can be nourished without stagnation, and the stomach earth can be moistened without dryness and constipation as the minister, assisting the monarch drug to regulate qi and blood; Sanleng Decoction promotes blood circulation to remove blood stasis, promotes qi movement and eliminates accumulation as the assistant, attacking and expelling qi and blood stasis in the body; Actinidia chinensis Planch., Coix lacryma-jobi L., and Coridius chinensis sautéed with wine are used in combination according to the disease to resolve phlegm-dampness, remove blood stasis, and relieve latent toxins as the envoy, making cancer toxins unable to grow and hide; Xihuang Pills clear heat and resolve toxins, dissipate swelling and masses, and slowly attack pathogenic toxins. When the toxins are removed, the healthy qi will recover on its own. The pill and decoction are used together, enabling the qi and blood to be generated with a source, the qi movement to rise and fall in an orderly manner, phlegm-dampness, blood stasis, depression, and toxins to have no chance to germinate, cancer toxins to be removed, and masses to be eliminated. Xihuang Pills: Originated from "Complete Collection of Surgical Syndrome Treatment" written by the Qing Dynasty doctor Wang Hongxu, it is exquisitely formulated with four medicinal materials: bezoar, musk, frankincense, and myrrh, and has the effects of clearing heat and resolving toxins, dissipating swelling and masses.

[0012] This invention employs a traditional Chinese medicine composition using a pill-decoction layering method. The composition includes raw Astragalus membranaceus, Curcuma zedoaria, and Codonopsis pilosula, which are mixed in a specific ratio to prepare a decoction, combined with Xihuang pills and apatinib. The decoction has a strengthening and consolidating effect, while the pills are mainly used to expel pathogens that have penetrated the collaterals and eliminate stagnation and toxins. This invention also relates to the use of the above composition in the preparation of drugs for treating advanced gastric cancer. Through a series of clinical cases, this therapy has shown significant efficacy in patients with advanced gastric cancer, with no serious adverse reactions observed. Attached Figure Description

[0013] Figure 1 This is the pathology report for the initial diagnosis of case 1 in Example 1; Figure 2 This is the gastroscopy report for the initial diagnosis of case 1 in Example 1; Figure 3 This is the test report of the patient in Example 1 before treatment with the method of the present invention; Figure 4 , Figure 5 This is the test report of the patient in Example 1 after treatment with the method of the present invention; Figure 6 This is the CT diagnostic report of the case in Example 1 before treatment with the method of the present invention; Figure 7 , Figure 8 This is the CT diagnostic report of the case in Example 1 after treatment with the method of the present invention; Figure 9 , 10 This is the gastroscopy report of the patient in Example 1 after treatment with the method of the present invention; Figure 11 , 12 This is the pathology report of the case in Example 1 after treatment with the method of the present invention; Figure 13 This is the test report of the patient in Example 2 before treatment with the method of the present invention; Figure 14 This is the test report of the patient in Example 2 after treatment with the method of the present invention; Figure 15 This is the test report of the patient in Example 3 before treatment with the method of the present invention; Figure 16 This is the test report of the patient in Example 3 after treatment with the method of the present invention; Figure 17 This is the CT diagnostic report of the case in Example 3 before treatment with the method of the present invention; Figure 18 This is the CT diagnostic report of the case in Example 3 after treatment with the method of the present invention. Detailed Implementation

[0014] Example 1 Ms. Yang, 73 years old, presented to the hospital on March 12, 2020. She had a 25-year history of type II diabetes and a 19-year history of hypertension. In early 2020, she began experiencing intermittent, dull pain and discomfort in the upper abdomen after eating, accompanied by acid reflux, belching, and decreased appetite. She underwent a gastroscopy on March 12, 2020. Figure 1 ): A large ulcer in the antrum of the stomach, pathologically indicated as poorly differentiated antral carcinoma ( Figure 2 Further chest and abdominal CT scans revealed enlarged perigastric, hilar, and retroperitoneal lymph nodes. Tumor staging: cT3N3M1, stage IV, Her-2 negative; no surgical treatment performed. First-line treatment: 5 cycles of intravenous chemotherapy were administered at Nanjing XX Hospital from March 26, 2020 to June 24, 2020. The regimen consisted of oxaliplatin 200mg day 1 + tegafur 40mg orally twice daily (days 1-14). Chemotherapy was well tolerated, and the condition was stable. From July 16th, one cycle of immunotherapy combined with chemotherapy was administered, consisting of toripalimab 240mg day 0 + oxaliplatin 200mg day 1 + tegafur 40mg orally twice daily (days 1-14). A follow-up CT scan on August 12th showed that the tumor had increased in size compared to the previous scan, and tumor progression was assessed. Second-line treatment: Nanjing XX Hospital switched to toripalimab 240mg day 0 + albumin-bound paclitaxel 200mg day 1 + cisplatin 30mg day 4 targeted chemotherapy for one cycle on August 14, 2020. After chemotherapy, grade III leukopenia occurred, which the patient could not tolerate. At our hospital, immunotherapy combined with chemotherapy was administered on September 15 and October 16, 2020, with the regimen of toripalimab 240mg day 0 + albumin-bound paclitaxel 300mg day 1. Due to continued intolerance to the side effects, the patient received maintenance immunotherapy with toripalimab 240mg for four cycles starting November 23, 2020. On May 13, 2021, the patient underwent a chest and upper abdominal enhanced CT scan at our outpatient clinic. The scan revealed: 1. Irregular thickening of the gastric antrum and body, accompanied by scattered small lymph nodes in the retroperitoneal space and lesser omentum, similar to the findings on the previous CT scan (21003751); 2. Scattered patchy, blurred shadows in both lungs, suggestive of inflammatory changes, and possibly immune-mediated pneumonia. The patient discontinued toripalimab treatment after developing immune-mediated pneumonia. Third-line treatment: The patient presented with dull epigastric pain, poor appetite, fatigue, acid reflux, and belching; a red tongue with a central fissure and a thin, white coating; and a rapid, forceful pulse. Pathogenesis analysis: Damage to both spleen and stomach qi and yin, resulting in impaired digestion and absorption, allowing cancerous toxins to enter the collaterals and linger. Treatment principle: Tonify qi and strengthen the spleen, nourish yin and harmonize the stomach, resolve masses and dissipate nodules, and gradually attack the cancerous toxins.

[0015] Medication - Pill and Decoction Stacking Method: Traditional Chinese Medicine Decoction: Raw Astragalus 30g, Curcuma zedoaria 30g, Codonopsis pilosula 15g, Sparganium stoloniferum 10g, Poria cocos 15g, Actinidia chinensis root 30g, stir-fried Atractylodes macrocephala 15g, ginger-processed Pinellia ternata 12g, Citrus reticulata peel 6g, wine-processed Eupolyphaga sinensis 5g, stir-fried Paeonia lactiflora 15g, wine-processed Angelica sinensis 10g, roasted Aucklandia lappa 6g, raw Coix lacryma-jobi 20g, Amomum villosum 5g (added later), honey-processed Glycyrrhiza uralensis 5g; Preparation and administration: Decoction using an automatic decoction machine, 200ml twice daily, taken warm half an hour after meals; Traditional Chinese medicine pills: Xihuang pills, 3g each time, twice a day, taken with the above decoction, half an hour after meals.

[0016] Apatinib mesylate tablets (brand name: Aitan): 250mg once daily, orally, half an hour after meals (it is recommended to keep the daily medication time fixed) and taken with warm water.

[0017] Treatment schedule: One treatment cycle consists of continuous medication for 28 days. At least two cycles should be completed, and medication should be discontinued when the condition progresses significantly or intolerable adverse reactions occur.

[0018] Efficacy Evaluation: February 9, 2023, a follow-up painless gastroscopy report showed: 1. Stage C2 chronic atrophic gastritis, changes after treatment of antral lesions, requiring further pathological examination; Pathology report: (antral) chronic inflammation of the mucosa with acute activity and focal intestinal metaplasia; (body) chronic inflammation of the mucosa; Helicobacter pylori test negative. February 7, 2023, CT scan showed thickening of the antral region. Overall efficacy assessment: Complete tumor remission; no tumor cells found in the pathology report; continue the original treatment plan. May 21, 2024, an outpatient MRI scan of the upper abdomen with contrast was performed: combined with the history of "gastric cancer," uneven thickening of the gastric wall and narrowing of the antral region were observed; filling defects in the main portal vein and its left branch were considered, suggesting thrombosis. June 12, 2024, a follow-up painless gastroscopy and colonoscopy were performed: post-chemotherapy status of gastric cancer (biopsy site: small antrum); scattered spider angiomas on the colonic mucosa; no obvious ulcers were seen on the gastric mucosa. Gastroscopy pathology report: (gastric antrum, biopsy) chronic mucosal inflammation with focal intestinal metaplasia, local tissue compression injury. Follow-up CT scan on October 13, 2025, imaging diagnosis: history of gastric cancer, localized thickening of the gastric wall (please combine with gastroscopy); localized uneven density of the main portal vein; multiple small lymph nodes in the abdominal cavity and retroperitoneum; blurred spaces in the abdominal cavity and retroperitoneal fat.

[0019] Efficacy and Safety Analysis: The patient was diagnosed with advanced gastric cancer and was not eligible for radical surgery. After first- and second-line treatments for gastric cancer, the survival time reached 13 months. Third-line treatment using a combination of herbal decoctions and oral medications resulted in complete tumor remission; the treatment regimen was maintained without change, and the patient has continued medication for 56 months with a good quality of life. Regarding safety: During initial apatinib treatment, the patient experienced severe hand-foot syndrome and fatigue. Symptoms improved after adjusting the dosage to 250mg orally every other day. In May 2024, the patient received aspirin combined with rivaroxaban anticoagulation therapy for celiac thrombosis, during which transient gastric bleeding occurred. Aspirin was discontinued, and apatinib was paused for half a month. Symptoms improved after acid suppression, gastric mucosal protection, and hemostasis. The patient is currently continuing treatment with the combination of herbal decoctions and oral medications.

[0020] contrast Figure 3 and Figure 4 , Figure 5 It can be seen that the comparison of tumor markers before and after treatment with this regimen shows that indicators such as CA199 have decreased significantly, indicating that the treatment is effective.

[0021] contrast Figure 6 and Figure 7 , Figure 8 As can be seen, the comparison of CT images before and after treatment shows that the condition is stable on CT images after treatment. Combined with the patient's general improvement, the treatment is deemed effective.

[0022] Figure 9 , Figure 10 The results showed that after treatment with this plan, the patient's condition remained stable under endoscopy, and combined with the patient's general improvement, the treatment was deemed effective.

[0023] Figure 11 , Figure 12 The results showed that after treatment with this regimen, no tumor cells were found in the pathology report, and the tumor was completely remitted.

[0024] Example 2 Patient Zhu XX, female, 52 years old. No significant past medical history. Present Illness: On November 26, 2021, the patient underwent laparoscopic partial gastrectomy with gastrojejunostomy under general anesthesia at XX Hospital in Jiangsu Province. Postoperative pathology showed two lesions in the distal stomach: 1. Ulcerative tubular adenocarcinoma of the gastric antrum, moderately to poorly differentiated, Lauren classification as intestinal type, tumor size 3×2×1cm, cancer tissue invading the serosa, with local vascular emboli and nerve invasion; 2. Superficial raised tubular adenocarcinoma of the gastric body, moderately to well differentiated, Lauren classification as intestinal type, lesion size 1.5×1cm, cancer tissue invading the lamina propria of the mucosa. No lymph node metastasis, pathological stage T4N0M0 (stage IIB). Immunohistochemical results: MSS, HER-2 (1+), CDX2 (focal +), Villin (local +). The patient started four cycles of DOX chemotherapy on December 17, 2021. The specific regimen was oxaliplatin 150mg day 1 + albumin-bound paclitaxel 200mg day 1 + capecitabine 1.5g bid day 1-14. The follow-up strategy was mainly based on regular check-ups.

[0025] In April 2023, the patient's tumor marker CA199 was 45 u / ml, which subsequently increased progressively, reaching 202 u / ml in July 2023. This was accompanied by symptoms such as loss of appetite and fatigue, and a significant weight loss of approximately 15 kg. On July 11, 2023, a PET-CT scan was performed at Jiangsu XX Hospital. The results indicated: 1. Multiple implantation metastases on the abdominal wall, left adnexa, and uterine surface, suggestive of post-gastric cancer surgery, with the possibility of local recurrence at the anastomosis site. A small nodule was visible on the outer edge of the right teres minor muscle, suggesting possible tumor metastasis. 2. The lower end of the left ureter was compressed or invaded by the tumor, accompanied by dilation and hydronephrosis of the left renal collecting system and left ureter, recommending further evaluation of renal function. On July 17, 2023, a ureteral stent was placed in the urology department. On July 18, the patient was treated with sintilimab 200 mg day 1 combined with tegafur 50 mg bid day 1-14, completing a total of 3 cycles. Tumor assessment progress. On October 19, 2023, the patient received five cycles of intravenous treatment with sintilimab 200mg plus albumin-bound paclitaxel 200mg. On March 8, 2024, a mass was found in the left adnexal region, suspected of metastasis. Laparoscopic examination, paracentesis, and laparoscopic adhesiolysis were performed. Postoperatively, intraperitoneal chemotherapy with cisplatin, raltitrexed, and paclitaxel was administered. On March 29, 2024, the patient received sintilimab 200mg day 0, albumin-bound paclitaxel 200mg day 1, and cisplatin 30mg day 1-3. On January 14, 2025, a comprehensive follow-up examination showed disease progression. The patient was subsequently treated with two cycles of sintilimab 200mg day 0, albumin-bound paclitaxel 200mg day 1, 100mg day 8, and oxaliplatin 100mg day 1, 50mg day 8. On March 4, 2025, tumor markers showed a progressive increase, with carbohydrate antigen CA199 at 1440 u / ml. The assessment indicated continued disease progression.

[0026] Treatment Method – Pill and Decoction Layering Method: Herbal Decoction: Astragalus membranaceus 25g, Curcuma zedoaria 20g, Codonopsis pilosula 10g, Sparganium stoloniferum 9g, Poria cocos 12g, Actinidia chinensis root 25g, Atractylodes macrocephala (stir-fried with wheat bran) 12g, Pinellia ternata (stir-fried with ginger) 10g, Citrus reticulata peel 5g, Eupolyphaga sinensis (stir-fried with wine) 4g, Paeonia lactiflora (stir-fried) 12g, Angelica sinensis (stir-fried with wine) 8g, Aucklandia lappa (stir-fried) 5g, Coix lacryma-jobi (stir-fried) 16g, Amomum villosum (stir-fried) 4g (added later), Glycyrrhiza uralensis (stir-fried with honey) 3g; Preparation and Administration: Decoction using an automatic decoction machine, 200ml twice daily, taken warm half an hour after meals; Traditional Chinese medicine pills: Xihuang pills, 3g each time, twice a day, taken with the above decoction, half an hour after meals.

[0027] Apatinib mesylate tablets (brand name: Aitan): 250mg once daily, orally, half an hour after meals (it is recommended to keep the daily medication time fixed) and taken with warm water.

[0028] Treatment schedule: One treatment cycle consists of continuous medication for 28 days. At least two cycles should be completed, and medication should be discontinued when the condition progresses significantly or intolerable adverse reactions occur.

[0029] On March 27, 2025, tumor markers showed a significant decrease, with CA199 levels at 900 u / ml. The treatment regimen was continued without modification, and the patient achieved a 3-month tumor remission period.

[0030] Efficacy and safety analysis: This patient experienced recurrence and metastasis 16 months after gastric cancer surgery. Following multiple lines of immunotherapy combined with chemotherapy and intraperitoneal perfusion, the patient achieved a survival of 23 months, demonstrating significant efficacy. After disease progression again, a "pillar-decoction layered treatment method" was adopted—using decoctions to protect the body's vital energy, pills for gradual and sustained attack, and combined with apatinib to inhibit tumor angiogenesis, resulting in another 3-month tumor remission. This regimen has proven suitable for later-line treatment of advanced gastric cancer, with manageable side effects and demonstrating safety and effectiveness.

[0031] contrast Figure 13 and Figure 14 Before treatment, the tumor marker CA199 level was 1440 u / ml, and after treatment, it was 900 u / ml, indicating a significant decrease in tumor markers and demonstrating the effectiveness of the treatment.

[0032] Example 3 Patient Wei XX, female, 48 years old, first visit on July 20, 2025. Chief complaint: 20 days after comprehensive treatment for advanced gastric malignancy. On August 9, 2024, the patient underwent gastroscopy at our hospital, which showed a large neoplasm protruding into the lumen on the greater curvature of the stomach, with scattered ulcers on the surface and a hard texture. Conclusion: gastric body lesion, possibly with cancerous changes and bleeding. Pathology: poorly differentiated carcinoma. Further CT scans of the chest and abdomen were performed at Zhenjiang XX Hospital, which showed: gastric cancer with multiple metastases in the abdominal cavity, retroperitoneum, left supraclavicular lymph nodes, and liver. Clinical stage: cT4N3M1, stage IV. Immunohistochemistry showed Her-2 negative. From August 14, 2024, she received four cycles of first-line chemotherapy combined with an immunotherapy regimen of "sintilimab 200mg d1 + oxaliplatin 150mg d1 + paclitaxel (albumin-bound) 300mg d1". Starting August 20, 2024, the patient underwent local radiotherapy to the thoracic spine, extending one vertebra above and below T11 (T10-12), with a dose of 30 Gy / 10 Fx. Following the fourth round of chemotherapy, grade III myelosuppression occurred, and the regimen was adjusted to two cycles of sintilimab 200 mg day 1 + paclitaxel (albumin-bound) 300 mg day 1 + capecitabine 1.0 g bid day 1-14. On February 16, 2025, a follow-up enhanced CT scan of the chest and abdomen at our hospital showed gastric carcinoma with a history of metastasis to the lesser omentum bursa, retroperitoneal lymph nodes, liver, and thoracic spine. Compared to the previous scan from November 18, 2024, some intrahepatic cystic lesions had slightly increased in size. Starting February 17, 2025, the patient underwent targeted immunotherapy with sintilimab 200 mg day 1 + capecitabine 1.0 g bid day 1-14 + apatinib 250 mg daily. After stage 1 treatment, tumor markers continued to rise, so the above regimen was added to oxaliplatin 150mg day 1 for stage 3 treatment. A follow-up PET-CT scan on May 13, 2025, showed a stable tumor size, but combined with the continued increase in tumor markers, the tumor was assessed as slowly progressing. From June 2, 2025, two cycles of immunotherapy-targeted chemotherapy (sintilimab + apatinib + irinotecan + tegafur) were initiated. During this period, mild to moderate myelosuppression and gastrointestinal reactions occurred. After evaluation, chemotherapy was discontinued, but targeted immunotherapy was continued. On July 20, 2025, carcinoembryonic antigen (CEA) increased from 339 ng / ml to 599 ng / ml. Current symptoms: Slight fatigue, shoulder and back pain, mild epigastric discomfort, slight nausea, poor appetite, no abdominal distension or diarrhea, no vomiting or hematemesis, normal bowel movements. Pale tongue, thin white greasy coating, thready and wiry pulse. Traditional Chinese Medicine (TCM) diagnosis: Stomach cancer; TCM etiology and pathogenesis: Spleen and stomach deficiency, qi stagnation due to deficiency of the middle jiao, disordered ascending and descending functions, and retention of cancer toxins; Pathogenesis analysis: Stomach fails to harmonize and descend, spleen fails to transform and transport, and qi stagnation due to deficiency of the middle jiao results in dull pain in the epigastric region, poor appetite, and nausea; Prolonged illness leads to deficiency, repeated chemotherapy depletes vital energy, and insufficient essence and blood, resulting in fatigue, pale tongue, and wiry and thready pulse; Prolonged illness affects the kidneys, leading to kidney essence deficiency and bone marrow depletion, allowing cancer toxins to enter and stagnate in the bone marrow, eroding bone tissue and causing shoulder and back pain.

[0033] Treatment Method – Pill and Decoction Layering Method: Herbal Decoction: Astragalus membranaceus 35g, Curcuma zedoaria 30g, Codonopsis pilosula 8g, Sparganium stoloniferum 12g, Poria cocos 8g, Actinidia chinensis root 35g, Atractylodes macrocephala stir-fried with wheat bran 20g, Pinellia ternata stir-fried with ginger 15g, Citrus reticulata peel 8g, Eupolyphaga sinensis (processed with wine) 6g, Paeonia lactiflora stir-fried with wine 18g, Angelica sinensis (processed with wine) 13g, Aucklandia lappa (processed with wine) 9g, Coix lacryma-jobi 25g, Amomum villosum 7g (added later), Glycyrrhiza uralensis (processed with honey) 6g; Preparation and Administration: Decoction using an automatic decoction machine, 200ml twice daily, taken warm half an hour after meals; Traditional Chinese medicine pills: Xihuang pills, 3g each time, twice a day, taken with the above decoction, half an hour after meals.

[0034] Apatinib mesylate tablets (brand name: Aitan): 250mg once daily, orally, half an hour after meals (it is recommended to keep the daily medication time fixed) and taken with warm water.

[0035] Treatment schedule: One treatment cycle consists of continuous medication for 28 days. At least two cycles should be completed, and medication should be discontinued when the condition progresses significantly or intolerable adverse reactions occur.

[0036] Follow-up until November 29, 2025: The patient's abdominal pain, fatigue, and loss of appetite had significantly improved compared to before, the PS score was 1, and the carcinoembryonic antigen (CEA) level had decreased to 436 ng / ml. Enhanced CT scans of the chest and entire abdomen showed a significant reduction in the size of the retroperitoneal lymph nodes, and all symptoms had been alleviated. The efficacy assessment was effective, with a median duration of response of 4 months.

[0037] contrast Figure 15 and Figure 16 A comparison of tumor markers before and after treatment showed that CEA decreased significantly from 599 to 436 after carcinoembryonic antigen (CEA) treatment; Simultaneously, a comparison with... Figure 17 and Figure 18 The comparison of CT images before and after treatment showed that the peritoneal lymph nodes were significantly reduced after treatment, thus the treatment was deemed effective.

Claims

1. A pill-and-decoction combination for treating advanced gastric cancer, characterized in that, This includes traditional Chinese medicine decoctions, traditional Chinese medicine pills, and targeted drugs for gastric cancer; The traditional Chinese medicine decoction consists of the following components by weight: 25-35 parts raw Astragalus membranaceus, 15-30 parts Curcuma zedoaria, 10-18 parts Codonopsis pilosula, 8-12 parts Sparganium stoloniferum, 12-18 parts Poria cocos, 25-35 parts Actinidia chinensis root, 12-20 parts stir-fried Atractylodes macrocephala, 10-15 parts ginger-processed Pinellia ternata, 5-8 parts Citrus reticulata peel, 4-6 parts wine-processed Eupolyphaga sinensis, 12-18 parts stir-fried Paeonia lactiflora, 8-13 parts wine-processed Angelica sinensis, 5-9 parts roasted Aucklandia lappa, 16-25 parts raw Coix lacryma-jobi, 4-7 parts Amomum villosum, and 3-6 parts honey-processed Glycyrrhiza uralensis; the traditional Chinese medicine pill is Xihuang Pill.

2. The pill-and-decoction combination for treating advanced gastric cancer according to claim 1, characterized in that, The targeted drug for gastric cancer is apatinib mesylate tablets.

3. A pill-and-decoction compound for treating advanced gastric cancer according to claim 1 or 2, characterized in that, The traditional Chinese medicine decoction consists of the following components by weight: 30 parts raw Astragalus membranaceus, 30 parts Curcuma zedoaria, 15 parts Codonopsis pilosula, 10 parts Sparganium stoloniferum, 15 parts Poria cocos, 30 parts Actinidia chinensis root, 15 parts stir-fried Atractylodes macrocephala, 12 parts ginger-processed Pinellia ternata, 6 parts dried tangerine peel, 5 parts wine-processed Euphorbia humifusa, 15 parts stir-fried Paeonia lactiflora, 10 parts wine-processed Angelica sinensis, 6 parts roasted Aucklandia lappa, 20 parts raw Coix lacryma-jobi, 5 parts Amomum villosum, and 5 parts honey-processed Glycyrrhiza uralensis.

4. Use of the composition according to any one of claims 1-3 in the preparation of a medicament for treating advanced gastric cancer.

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