Overview
This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of treatment with Camrelizumab (SHR-1210) + definitive chemoradiotherapy(dCRT) vs placebo+dCRT for locally advanced esophageal cancer patients in China. Camrelizumab (SHR-1210) is a humanized anti-PD1 IgG4 monoclonal antibody.
Description
In this study, eligible subjects will be randomized into study arm or control arm. Participants receive camrelizumab or placebo + chemotherapy + radiation therapy . The chemotherapy regimens are : paclitaxel plus cisplatin Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) will be the primary outcomes.
Eligibility
Inclusion Criteria:
1.18 to 75 years; 2.Histologically confirmed diagnosis of localized ESCC; 3.Measurable and/or non-measurable disease defined per RECIST v1.1; 4.ECOG Performance Status 1; 5.Adequate organ function
Exclusion Criteria:
- Indicators of severe malnutrition;
- A history of surgery for esophageal cancer;
- Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
- Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy;
- Received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology therapies;
- Active autoimmune diseases or history of autoimmune diseases that may relapse