Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC
Trial Parameters
Brief Summary
This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.
Eligibility Criteria
Inclusion Criteria: 1. Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma. 2. Confirmed metastatic or locally advanced, unresectable disease. 3. Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine or platinum/taxane doublet. 4. Willing to provide tumor tissue for PD-L1 biomarker analysis. 5. Human epidermal growth factor receptor 2 (HER-2/neu) status known and participants with HER2/neu positive tumors show documentation of previous treatment containing trastuzumab. 6. ECOG performance status of 0 to 1. 7. Life expectancy of more than 12 weeks. 8. Signing the informed consent forms. 9. Adequate bone marrow, liver and renal function. Exclusion Criteria: 1. Squamous cell or undifferentiated gastric cancer. 2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 3. Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who a