Gastric cancer
Conditions
Interventions
Experimental group:Sintilimab and ramucirumab combined with chemotherapy
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in clinical research; Fully understand and be informed about the study, and sign the Informed Consent Form (ICF); Willing to follow and be capable of completing all experimental procedures. 2. Be =18 years old and =75 years old at the time of signing the ICF. 3. Histologically or cytologically confirmed, locally advanced unresectable or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma (including signet-ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma). 4. No prior antitumor therapy. 5. The subjects must provide the test results of PD-L1. 6. ECOG PS score of 0 or 1 within 7 days prior to first dose. 7. The expected survival period is = 3 months. 8. Hepatitis B surface antigen (HBsAg) (-) and Hepatitis B core antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), Hepatitis B virus Deoxyribonucleic Acid (HBV DNA) must be <1000 copies/mL or<200IU/mL or <the upper limit of normal value (ULN) at the research center for enrollment. 9. HCV antibodies (-). 10. Normal major organ function, i.e., the following criteria are met (no blood transfusions, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) therapy within 14 days prior to the first dose): a. Blood routine White blood cell (WBC) normal value range Neutrophils (NE) normal value range Platelets (PLT) = 100 × 10 ^ 9/L Hemoglobin (Hb) = 90g/L b. Blood biochemistry (liver and kidney function) Total bilirubin (TBIL) = 1.5 × Upper limit of normal value (ULN) Alanine aminotransferase (ALT) = 2.0 × Upper limit of normal value (ULN) Asparagus cochinchinensis aminotransferase (AST) = 2.0 × Upper limit of normal value (ULN) Albumin = 30g/L Creatinine (Cr) normal value range c. Coagulation function Activated partial thromboplastin time (APTT) = 1.5 × Upper limit of normal value (ULN) Prothrombin time (PT) = 1.5 × Upper limit of normal value (ULN) International standardized ratio (INR) = 1.5 × Upper limit of normal value (ULN)
Exclusion criteria
Exclusion criteria: 1. Within 5 years or concurrently with other active malignant tumors. Cured limited tumors such as basal cell carcinoma of the skin, Cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast may be enrolled. 2. Those who have undergone surgery (including incisional biopsy) within 4 weeks prior to the start of study treatment or those who need to undergo surgery during the study treatment. 3. Those who have central nervous system disease or symptoms of central nervous system metastasis. 4. Patients who are preparing for or have previously received an organ or bone marrow transplant. 5. have a history or evidence of thrombosis or bleeding disorders within 6 months prior to the first study treatment. 6. have active tuberculosis. 7. patients with previous and current interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis, or severely impaired lung function that may interfere with the detection and management of suspected drug-related pulmonary toxicity. 8. Patients with poorly controlled hypertension (SBP =150 and/or DBP =100), prior hypertensive crisis, or history of cardiovascular disease (=Grade II or worse congestive heart failure, myocardial ischemia, unstable angina pectoris, stroke, or transient ischemic attack). 9. Patients with risk factors for gastrointestinal perforation (previous gastrointestinal fistula, history of perforation, abdominal abscess, partial or complete small bowel obstruction, or need for complete parenteral nutrition). 10. Patients with moderate to severe proteinuria. 11. Patients with non-healing wounds, ulcers or fractures. 12. Presence of known active or suspected autoimmune disease. Except for those who are in a stable state of the disease at the time of enrollment (not requiring systemic immunosuppressive therapy). 13. Known history of severe allergy to any monoclonal antibody and excipients. 14. Known history of psychotropic substance abuse or drug addiction; patients who have stopped drinking alcohol may be enrolled. 15. Presence of patients with potentially increased risk of study drug use, or other severe, acute and chronic medical conditions that, in the judgment of the investigator, make them unsuitable for participation in clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival;Incidence rate of adverse events and Serious adverse event; | — |
Countries
China
Contacts
Public ContactHao Wu
Jiangsu Province Hospital
Outcome results
None listed