Gastric cancer
Conditions
Interventions
Group A:Intraperitoneal injection of bevacizumab + white purple/seggio/PD-1 inhibitor system therapy
Group B:White violet/Sigiol/PD-1 inhibitor/bevacizumab system therapy.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Aged 18-70 years, no gender limit; 3. Histologically or cytologically confirmed peritoneal metastasis of gastric cancer; 4. Have not received systemic therapy before, or the time from the end of (neo) adjuvant chemotherapy/adjuvant radiotherapy to the time of disease recurrence > 6 months; 5. HER2 negative; 6. ECOG score 0-1 points; 7. Expected survival time > 3 months; 8. Sufficient organ function, subjects should meet the following laboratory indicators: (1) The absolute value of neutrophils (ANC) is >=1.5x10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days; (2) Platelets >=100x10^9/L without blood transfusion in the past 14 days; (3) Hemoglobin>9g/dL without blood transfusion or erythropoietin use in the past 14 days; (4) Total bilirubin =60 ml/min; urine dipstick test results show urine protein <2+; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) Myocardial enzyme spectrum is within the normal range (if the investigators comprehensively judge that the simple laboratory abnormality does not have clinical significance, it is also allowed to be included); 9. For female subjects of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age are defined as having been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; 10. If there is a risk of conception, all subjects (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of the study drug (or 180 days after the last chemotherapy drug dose).
Exclusion criteria
Exclusion criteria: 1. Nearly obstruction of the cardia and pylorus affects the patient's eating and gastric emptying, or has difficulty swallowing tablets; 2. Diagnosed with other malignant diseases other than gastric cancer within 5 years before the first administration (excluding basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 3. It is known to show signs of active bleeding in the lesion under endoscopy; 4. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose; 5. Previous therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or against another stimulating or synergistic inhibitory T cell receptor (eg, CTLA-4, OX-40, CD137) drug; 6. Received systemic systemic treatment of Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, and interleukin, except for local use for controlling pleural effusion) within 2 weeks before the first administration; 7. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy; 8. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (<=10 mg/day prednisone or equivalent) are allowed; 9. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 10. Those who are known to be allergic to the active ingredients or excipients of the study drugs sintilimab and bevacizumab; 11. Those with multiple factors affecting capecitabine (such as inability to swallow and intestinal obstruction, etc.); 12. Have not recovered sufficiently from toxicity and/or complications from any intervention (ie, <= Grade 1 or reached baseline, excluding fatigue or alopecia) prior to initiating treatment; 13. Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive); 14. Untreated active hepatitis B (defined as HBsAg positive and the detection of HBV-DNA copy number greater than the upper limit of normal in the laboratory department of the research center); Note: Hepatitis B patients who meet the following criteria can also be enrolled: (1) HBV viral load <1000 copies/ml (200 IU/ml) before the first administration, patients should receive anti-HBV therapy throughout the study chemotherapy drug treatment to avoid the virus reactivate; (2) For patients with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV treatment is not required, however, close monitoring of virus reactivation is required; 15. Active HCV infected patients (HCV antibody positive and HCV-RNA level higher than the detection limit); 16. Received live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Inactivated virus vaccine for injection against seasonal influenza within 30 days before the first dose is allowed; however, live attenuated influenza
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness of ascites control;Progression-free survival;Overall survival;Objective response rate;Disease control rate;1-year overall survival;Disease remission time;Duration of relief; | — |
Countries
China
Contacts
Public ContactZhang Tao
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed