Status:
UNKNOWN
Study of Camrelizumab (SHR-1210) in Combination With Concurrent Chemoradiotherapy in Locally Advanced Esophageal Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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)...
Detailed 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 : pac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT04426955
Start Date
June 30 2020
End Date
December 1 2023
Last Update
September 16 2021
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China