Gastric cancer
Conditions
Interventions
Trail group:NA
Sponsors
Hubei Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age: 18 years old or above, male or female; 2) Adenocarcinoma of the stomach or gastroesophageal junction confirmed by pathology or histology, with locally advanced lesions or distant metastases that cannot be surgically removed. 3) I have not received systematic treatment for advanced or metastatic GC/GEJ in the past. For patients who have previously received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy, or radiochemotherapy) for GC/GEJ, their last treatment must be completed at least 6 months before randomization and there must be no recurrence or disease progression at the time of treatment completion. Patients are allowed to undergo palliative radiotherapy, but it must be completed at least 2 weeks before the first study treatment. 4) The subjects have been determined by the researchers to be suitable for first-line immunotherapy combined with chemotherapy, and the patients are willing to accept first-line immunotherapy combined with chemotherapy; 5) HER2 negative; 6) ECOG: 0-1 points; 7) Having measurable lesions that meet the RECIST 1.1 standard; 8) Having sufficient organ and bone marrow function, defined as follows: a) Hemoglobin = 90g/L, b) Absolute neutrophil count (ANC) = 1.5 × 109/L, c) Platelets = 100 × 109/L, d) ALT, AST = 2.5 times the normal upper limit value, = 5 times the upper normal limit (for those with liver metastasis), e) Serum total bilirubin = 1.5 times the upper normal limit value, f) Serum creatinine = 1.5 times the upper normal limit value, g) Serum albumin = 30g/L; h) Urinary protein<2+; If the urine protein is = 2+, the 24-hour urine protein quantitative display must be = 1g; i) International standardized ratio (INR) = 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) = 1.5 times ULN; 9) The subjects should provide tumor tissue samples: fresh samples or formalin fixed and paraffin embedded tumor tissue samples (FFPE) obtained from the first 6 months of randomization; 10) The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1) positive HER2; 2) Gastric cancer known to be squamous cell carcinoma, undifferentiated carcinoma or other tissue types, or adenocarcinoma mixed with other tissue types; 3) The presence of uncontrolled or symptomatic active central nervous system (CNS) metastases, which may be manifested by the presence of clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, pia meningeal disease, and/or progressive growth; 4) Received the following treatments or medications before randomization: - Major surgery within 28 days prior to randomization (diagnostic tissue biopsy and peripheral venipathesis with central venous catheter placement [PICC] are permitted); - Receiving antitumor therapy (including intraperitoneal perfusion, systemic chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biotherapy, or tumor embolization) within 28 days prior to randomization; 5) Untreated active hepatitis (hepatitis B, defined as HBV-DNA = 500 IU/ml; Hepatitis C, defined as HCV-RNA above the lower detection limit of analytical methods) or co-infection with hepatitis B and hepatitis C; 6) Received anti-PD-1 /PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, anti-ctLA-4 antibodies, or other drugs/antibodies acting on T cell costimulation or checkpoint pathways; 7) Systemic antibiotic use = 7 days within the 4 weeks prior to randomization, or unexplained fever >38.5°C prior to initial administration during the screening period (as determined by the investigator, fever due to tumor could be included) 8) Patients with a history of psychotropic drug abuse and unable to abstain or patients with mental disorders; 9) Patients with concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the patient or affect the completion of the study; 10) Those considered unsuitable for inclusion by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;Nutrition curve; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS; | — |
Countries
China
Contacts
Public ContactHuiting Xu
Hubei Cancer Hospital
Outcome results
None listed