Cancer of the stomach
Conditions
Interventions
Central group:CAPOX regimen combined with sindilizumab and bevacizumab
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological or cytological diagnosis confirmed adenocarcinoma of the stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma); 2. Imaging and surgical evaluation of patients with unresectable recurrence or metastasis; 3. The expected survival period is more than 3 months; 4. The age is between 18 and 75 years old, male and female; 5. Have not received systematic treatment for patients with advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction in the past. If the patients with gastric and gastroesophageal junction adenocarcinoma have received adjuvant or neoadjuvant treatment (including chemotherapy, radiotherapy and chemotherapy) in the past, their last treatment must be completed at least 6 months before randomization and there is no recurrence or disease progression at the time of treatment. Subjects are allowed to undergo palliative radiotherapy, but it must be completed at least 2 weeks before the first study treatment. Subjects are allowed to have received anti-tumor traditional Chinese medicine preparations in the past, but must stop using them at least 2 weeks before randomization; 6. ECOG physical strength status is 0 – 1; 7. At least one lesion can be evaluated according to RECIST 1.1 standard; 8. Be able to provide pathological tissue or fresh pathological tissue archived within 6 months from the signing of the screening informed consent for PD-L1 test and obtain the test results. For the sections archived within 6 months before randomization, it should be confirmed that no systemic treatment (including adjuvant/neoadjuvant treatment) has been received after obtaining the samples; 9. The function of main organs is normal, that is, they meet the following standards: 1) Routine blood test (no blood transfusion and G-CSF used within 14 days before screening): a) Hemoglobin = 90 g/L; b) Absolute neutrophil count (ANC) = 1.5 × 109/L c) Platelet count = 75 × 109/L 2) Blood biochemical examination (no albumin was used within 14 days before screening): a) Albumin = 28 g/L; b) Total bilirubin = 1.5 × Upper limit of normal value (ULN); c) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 3 × ULN In case of liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 5 × ULN d) Creatinine = 1.5 × ULN 2) Coagulation function: a) International normalized ratio (INR) or prothrombin time (PT) = 1.5 × ULN b) Activated partial thromboplastin time (APTT) = 1.5 × ULN 10. For the sections archived within 6 months before randomization, it should be confirmed that no systemic treatment (including adjuvant/neoadjuvant treatment) has been received after obtaining the samples; 11. The acute toxic reaction caused by previous anti-tumor treatment or surgery has been relieved to 0-1 level (according to NCICTCAE version 5.0) or to the level specified in the inclusion/exclusion criteria; 12. Female subjects of childbearing age must carry out a serum pregnancy test within 3 days before starting the study medication, and the result is negative, and are willing to use a medically approved effective contraceptive measure (such as intrauterine device, pregnancy avoidance drug or condom) during the study period and within 3 months after the last administration of the study medication; 13. For male subjects whose partners are women of childbearing age, they should undergo surgical sterilization
Exclusion criteria
Exclusion criteria: 1. Known to be HER2 positive; 2. Gastric cancer known as squamous cell carcinoma, undifferentiated or other tissue types, or adenocarcinoma mixed with other tissue types; 3. There is uncontrolled or symptomatic active central nervous system (CNS) metastasis, which can be manifested as clinical symptoms, brain edema, spinal cord compression, cancer metastasis, cancerous meningitis, leptomeningeal disease and/or progressive growth. If CNS metastasis has been adequately treated and the symptoms of the nervous system can recover to the baseline level at least 2 weeks before randomization (except for the residual signs or symptoms related to CNS treatment), it can be included in the study. In addition, the subjects must stop using corticosteroids or receive prednisone (or other equivalent corticosteroids) at a stable dose of = 10 mg/d or a gradually reduced dose at least 2 weeks before randomization; 4. There were hydrothorax and ascites that could not be controlled after puncture and drainage within 14 days before randomization; 5. The weight of subjects with clinical symptoms or with moderate or more pericardial effusion decreased by more than 20% in the first 2 months of randomization; 6. Have received the following treatment or drugs before randomization: 1) Excessive surgery was performed within 28 days before randomization (PICC is allowed for tissue biopsy and central catheter insertion through peripheral vein puncture due to diagnosis; 2) Immunosuppressive drugs were used within 7 days before randomization, excluding nasal spray and inhaled corticosteroids or physiological dose of systemic hormones (i.e. no more than 10 mg/d of nisone or other corticosteroids with physiological dose of the same drug); 3) Inoculate live attenuated vaccine within 28 days before randomization or within 60 days after drug treatment; 4) They received anti-tumor treatment (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy or tumor embolization) within 28 days before randomization. Any other malignant tumor was diagnosed within 3 years before entering the study, except for skin basal cell carcinoma or squamous, superficial bladder cancer carcinoma, cervical carcinoma in situ, breast intraductal carcinoma and thyroid papillary carcinoma that can be treated locally and have healed. 7. Any active, known or suspected autoimmune disease; 8. It is allowed to select the subjects who are in a stable state and do not need systemic immunosuppressive treatment, such as: type I diabetes, hypothyroidism diabetes that only needs hormone replacement treatment, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis and alopecia); 9. Previously received anti-PD-1/PD-L1 antibody, anti-CTLA-4 antibody or other drugs that act on T cell co-stimulation or check cell co-stimulation or check point pathway; 10. There were clinically significant bleeding symptoms or clear bleeding tendency within 3 months before randomization; Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before randomization; 11. Arterial/venous thrombosis events occurred within 6 months before randomization, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 12. Major vascular disease (such as aortic aneurysm requiring surgical repair or recent peripheral arterial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival; | — |
Countries
chengdu
Contacts
Public ContactLiu Ming
West China Hospital of Sichuan University
Outcome results
None listed