Advanced (oligometastatic) gastric cancer
Conditions
Interventions
Arterial group:S-1 40mg~60/m2, Bid, d1-14, q3week × 3 cycles
Oxaliplatin 100mg/m2, arterial perfusion, d1, q3week × 3 cycles
Epirubicin 30 mg/m2, arterial perfusion, d1, q3week × 3 cycles
Xindiliximab 200mg, intravenous drip, d2, q3week × 3 cycles
Intravenous group:S-1 40mg~60/m2, Bid, d1-14, q3week × 3 cycles
Oxaliplatin 100mg/m2, intravenous infusion, d1, q3week × 3 cycles
Sponsors
General Hospital of Eastern Theatre Command
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects eligible for inclusion in this study must meet all of the following criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Age= 18 years old and = 75 years old, gender is not limited; 3. Adenocarcinoma of the gastric and gastroesophageal junction diagnosed by histopathological examination; 4. Patients with advanced gastric cancer with a single distant metastasis who cannot be resected without resection; 5. No previous anti-tumor therapy (radiotherapy, chemotherapy, targeted or immunotherapy, etc.); 6. The screening period using CT or MRI, PET-CT, and other examinations indicates that there is only 1 unresectable factor: 1) According to abdominal aortic lymph node metastasis (No.16a2/b1) 2) Virchow lymph node metastasis 3) Hepatic oligometastasis 4) Oligometastasis of the lungs 5) Ovarian oligostasis 6) Peritoneal oligometastatic: only positive peritoneal cytology (CY1P0), or only visible peritoneal implantation P1 7. Solid tumor efficacy evaluation criteria (RECIST version 1.1), at least one imaging can measure the lesion; 8. ECOG scores 0-1 points; 9. Expected survival time> 3 months; 10. Sufficient organ function, subjects need to meet the following laboratory indicators: 1) In the case of no use of granulocyte colony-stimulating factor in the past 14 days, the absolute value (ANC) of neutrophils = 1.5x109/L. 2) In the case of no blood transfusion in the past 14 days, platelets = 100×109/L. 3) In the case of no blood transfusion or use of erythropoietin in the past 14 days, hemoglobin > 9g/dL; 4) Total bilirubin =1.5× upper limit of normal value (ULN); 5) aspartate aminotransferase (AST), alanine aminotransferase (ALT) at =2.5 × ULN (subjects with liver metastases are allowed ALT or AST =5×ULN); 11. Serum creatinine =1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) = 60 ml/min; 12. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; 13. Normal thyroid function, is thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, participants may also be enrolled if total T3 (or FT3) and FT4 are within the normal range; 14. For female subjects of childbearing age, a urine or serum pregnancy test should be received within 3 days before the first study drug administration (Day 1 of Cycle 1) with a negative result. If a urine pregnancy test cannot be confirmed as unfavorable, a blood pregnancy test is ordered. Non-childbearing age women are defined as at least 1 year postmenopausal or have undergone surgical sterilization or hysterectomy; 15. If there is a risk of conception, all subjects (whether male or female) are required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last study drug administration (or 180 days after the previous chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: Participants who meet the following criteria were not eligible for inclusion in this study: 1. Distal metastases other than oligometastatic as defined in the enrollment criteria (e.g., brain, bone, etc.); 2. Her-2 test positive; 3. Known endoscopic signs of active bleeding of the lesion, history of gastrointestinal perforation and fistula within 6 months; 4. Other malignant diseases other than gastric cancer diagnosed within 5 years before the first administration (excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection); 5. Currently participating in intervening clinical investigational treatment, receiving other investigational drugs, or using investigational devices within 4 weeks before the first dose; 6. Previous treatment of anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 7. Received proprietary Chinese medicine or immunomodulatory drugs with anti-tumor indications (including thymus peptide, interferon, interleukin, except topical use to control ascites) systemic systemic therapy within 2 weeks before the first administration; 8. Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 9. Receiving systemic glucocorticoid therapy (excluding nasal, inhaled, or other routes of topical corticosteroids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: The use of physiologic doses of glucocorticoids (= 10 mg/day of prednisone or equivalent) is allowed; 10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 11. Those who are known to be allergic to the active ingredients or excipients of the study drug Cindilibu, anti capecitabine, and oxaliplatin; 12. There are a variety of factors that affect oral drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, cardia and pyloric near-obstruction affecting eating and gastric emptying); 13. Have not adequately recovered from toxicity and/or complications caused by any intervention before initiation of treatment (i.e., grade = 1 or baseline, excluding fatigue or alopecia); 14. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 15. Uncontrolled active hepatitis B (defined as HBsAg positive and HBV-DNA copy number more significant than the upper limit of normal values in the laboratory department of the research center); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: 1) HBV viral load < 1000 copies/ml (200 IU/ml) before first administration, subjects should receive anti-HBV therapy throughout the study drug treatment period to avoid viral reactivation 2) For subjects anti-HBc(+), HBsAg(-), anti-HBs(-), anti-HBs(-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required 3) subjects with active HCV infection (positive for HCV antibodies and HCV-RNA levels above the lower limit of detection); 16. Have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion rate of acceptable surgery after conversion therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 excision rate;ORR;EFS;MPR;CTCAE 5.0;OS; | — |
Countries
China
Contacts
Public ContactXiaosong Xiang
General Hospital of Eastern Theatre Command
Outcome results
None listed