Study of Camrelizumab (SHR-1210) in Combination With Concurrent Chemoradiotherapy in Locally Advanced Esophageal Cancer
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- STATUS
- Recruiting
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- participants needed
- 390
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- sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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 | 18-75 years |
| Treatment | Placebo, Paclitaxel, Cisplatin, Radiation, Camrelizumab |
| Clinical Study Identifier | NCT04426955 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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