Overview

Study of Camrelizumab (SHR-1210) in Combination With Concurrent Chemoradiotherapy in Locally Advanced Esophageal Cancer

Status:
Active, not recruiting

Trial end date:
2023-12-01

Target enrollment:
0

Participant gender:
All

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) vs placebo+dCRT for locally advanced esophageal cancer patients in China. Camrelizumab (SHR-1210) is a humanized anti-PD1 IgG4 monoclonal antibody.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Jiangsu HengRui Medicine Co., Ltd.

Treatments:

Cisplatin
Paclitaxel

Criteria

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:

1. Indicators of severe malnutrition;

2. A history of surgery for esophageal cancer;

3. Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring
frequent drainage or medical intervention;

4. Known to be intolerable or resistant to treatment with the protocol-specified
chemotherapy;

5. Received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology
therapies;

6. Active autoimmune diseases or history of autoimmune diseases that may relapse