Spots Global Cancer Trial Database for Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer

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Trial Identification

Brief Title: Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer

Official Title: PD-1 Antibody SHR-1210 Combined With Paclitaxel and Cisplatin Versus Placebo Combined With Paclitaxel and Cisplatin as First-line Therapy for Advanced Esophageal Cancer: a Randomized, Double-blinded, Controlled, Multi-center Phase III Trial

Study ID: NCT03691090

Conditions

Advanced Esophageal Cancer

Interventions

Study Description

Brief Summary: This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

Detailed Description: In this study, eligible subjects will be randomized into study arm or control arm. Treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and overall survival (OS) will be the primary outcomes.