A Single-arm, Phase II Study of Camrelizumab Combined With S-1 Maintenance After First-Line Induction Chemotherapy in Patients With HER2 Negative Advanced Gastric Cancer
In this study, We investigated the efficacy and safty of camrelizumab combined with S-1 maintenance after first-line induction chemotherapy for GC. Patients without progressive disease after 4-6 weeks of first-line chemotherapy with SOX will be treated with camrelizumab combined with S-1.
• Male or female subjects aged from 18 to 75 years old;
• Subjects with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ);
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry;
• Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
• Estimated life expectancy of more than 3 months;
• Adequate haematological, hepatic and renal functions defined by the protocol;
• Negative blood pregnancy test at Screening for women of childbearing potential; Highly effective contraception for both male and female subjects if the risk of conception exists;