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

  • STATUS
    Recruiting
  • participants needed
    390
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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Updated on 19 February 2024
See if I qualify
cancer
measurable disease
paclitaxel
monoclonal antibodies
monoclonal antibody therapy
chemoradiotherapy
shr-1210
esophageal cancer
squamous cell carcinoma of esophagus
antibody therapy
camrelizumab
cisplatin

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.

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.

Details
Condition Esophageal Diseases, Esophageal Cancer, Esophageal Cancer, head and neck cancer, head and neck cancer
Age 18years - 75years
Treatment Placebo, Paclitaxel, Cisplatin, Radiation, Camrelizumab
Clinical Study IdentifierNCT04426955
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

18 to 75 years; 2.Histologically confirmed diagnosis of localized ESCC
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
Clear my responses
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cancer
measurable disease
paclitaxel
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shr-1210
esophageal cancer
squamous cell carcinoma of esophagus
antibody therapy
camrelizumab
cisplatin

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