Gastric/gastroesophageal junction adenocarcinoma
Conditions
Interventions
Single-arm research Group:1. Chemotherapy: CAPOX regimen (Capecitabine 1000 mg/m^2, oral, twice daily on days 1 to 14
Oxaliplatin 130 mg/m^2, intravenous infusion on day 1), every three weeks
2. Immunotherapy: Suluilumab 200mg, intravenous infusion on day 1, every three weeks
3. Oral immunonutrition: Zhiyisu 200ml/bottle, two bottles daily, continuous oral administration until disease progression or surgery
4. Probiotics: Ataining (Clostridium butyricum capsules), 6 capsules each time, once daily, continuous oral administration until disease progression or surgery.
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old, gender not specified; 2. Patients diagnosed with adenocarcinoma of the stomach or gastroesophageal junction (GEJ) through histological or cytological examination were included in the study only if they had Siewert type III adenocarcinoma of the GEJ or Siewert type II adenocarcinoma of the GEJ that did not require combined thoracotomy surgery. 3. Before treatment, CT, MRI or PET-CT were used to confirm the presence of severe lymph node metastasis. The following factors or multiple factors simultaneously were considered: (1) 16 groups of a2 and/or b1 lymph nodes around the abdominal aorta metastasis (>=1.0 cm); (2) Massive or fused lymph node metastasis (Bulky N: refers to enlarged lymph nodes with a long diameter of >=3 cm, or two adjacent lymph nodes with a long diameter of >=1.5 cm); (3) cN3: metastasis of 7 or more regional lymph nodes (circularly enlarged lymph nodes, short diameter > 6-8 mm; high enhancement or uneven enhancement, short-long diameter ratio > 0.7, multiple clusters); and/or oligometastasis, defined as meeting one of the following factors: 1) peritoneal metastasis (P1); 2) positive free cancer cells in the abdominal cavity (CY1); 3) liver metastasis (lesions = 2 weeks. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 6. Expected survival time >= 6 months; 7. The main organ functions are basically normal (no blood transfusion, albumin infusion, recombinant human thrombopoietin or colony-stimulating factor treatment within 14 days before enrollment), the cardiac function is good, and there is no active infection. 8. Indications for excluding chemotherapy, immunotherapy, immunonutrition, and probiotic treatment; 9. Before being included in the study, there were no other uncontrollable benign diseases such as infections in the lungs, kidneys, or liver. 10. Female patients must meet the following requirements: - Menopause (defined as no menstruation for at least 1 year, and no other confirmed cause except menopause), or surgical sterilization (removal of ovaries and/or uterus), or patients with reproductive capacity must also meet the following conditions: (1) The serum pregnancy test result within 7 days before enrollment must be negative; (2) Agree to use a contraceptive method with an annual failure rate of less than 1% or remain abstinent (avoiding heterosexual sexual intercourse) (from signing the informed consent form to the last administration of the trial drug, at least 120 days after the last administration of chemotherapy drugs, and at least 6 months after the last administration of chemotherapy drugs) (Contraceptive methods with an annual failure rate of less than 1% include bilateral tubal ligation, male sterilization, correct use of hormone contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper-containing intrauterine devices.); (3) Cannot breastfeed. Male patients must meet the following requirements: - Agree to abstain from sexual intercourse (avoiding heterosexual sexual intercourse) or use a contraceptive method, as follows: If the partner is a ferti
Exclusion criteria
Exclusion criteria: 1. Including the history of malignant tumors in other parts, the patient has received potentially curative treatment and there is evidence that the disease is absent within 5 years. The cases of successful resection for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, and other carcinoma in situ are excluded. 2. Patients with HER2-positive gastric adenocarcinoma or GEJ adenocarcinoma; 3. The following distant metastases, confirmed by imaging or pathological examination, include but are not limited to lung metastasis, bone metastasis, adrenal metastasis, central nervous system metastasis, leptomeningeal metastasis, spinal cord compression or leptomeningeal diseases, etc. 4. Borrmann Type IV; 5. Patients who are preparing for or have previously undergone organ or bone marrow transplantation; 6. Having had or currently having congenital or acquired immune deficiency diseases; 7. Active or previously documented autoimmune diseases or inflammatory disorders, such as autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, pituitary inflammation, hyperthyroidism or hypothyroidism, asthma requiring bronchodilator treatment, etc. 8. Within 6 months prior to enrollment, there was a history of myocardial infarction or uncontrolled arrhythmia (including QTc interval of = 450 ms for males and = 470 ms for females) (QTc interval is calculated using the Fridericia formula); 9. There is NYHA grade III-IV cardiac dysfunction or cardiac ultrasound examination showing LVEF (left ventricular ejection fraction) 10 mg/day prednisone) or other immunosuppressive drugs within 14 days before enrollment or during the study period. However, the following situations allow for enrollment: Patients without active autoimmune diseases are permitted to use topical or inhaled corticosteroids, or adrenal hormone replacement therapy with a dose of = 10 mg/day prednisone. 14. Within 14 days prior to enrollment, any active infection requiring systemic anti-infective treatment occurred; except for cases where prophylactic antibiotic therapy was administered (such as for preventing urinary tract infections or chronic obstructive pulmonary disease); 15. The time elapsed since the completion of the previous clinical study treatment is less than 14 days, and the patient is currently undergoing or planning to commence the treatment for this study. 16. It is known that there is a history of severe allergic reaction to any monoclonal antibody or research drug excipient. 17. During the treatment period, antibiotics, probiotics, yogurt or foods rich in bacteria are being used or are planned to be used. 18. Pregnant or lactating women, as well as women or men with reproductive capacity who are unwilling or unable to take effective contraceptive measures; 19. There are patients who may
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug safety;Surgical safety;Progression-free survival rate;Primary pathological remission; | — |
Countries
China
Contacts
Public ContactChen Xiaodong
Sichuan Cancer Hospital
Outcome results
None listed