Camrelizumab vs Placebo as Maintenance Therapy After dCRT in Locally Advanced ESCC
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|ClinicalTrials.gov Identifier: NCT03985046|
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Kuai Le Zhao, MD, Fudan University
The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab vs placebo as maintenance therapy after definitive concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Squamous Cell Carcinoma||Drug: Camrelizumab Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Double-blind Phase II Study of Camrelizumab vs Placebo as Maintenance Therapy After Definitive Concurrent Chemoradiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2022|
Camrelizumab will be administered intravenously, a fixed dose of 200 mg. Each infusion lasts for 30 min, once every 2 weeks. The cumulative longest medication period is 12 months.
|Placebo Comparator: Placebo||
Placebo will be administered intravenously, a fixed dose of 200 mg. Each infusion lasts for 30 min, once every 2 weeks. The cumulative longest medication period is 12 months.
Primary Outcome Measures :
- progression-free survival [ Time Frame: up to 42 months ]
- overall survival [ Time Frame: up to 42 months ]
Secondary Outcome Measures :
- Adverse Events [ Time Frame: up to 42 months ]
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