Study of SHR-1210 Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal Cancer
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ClinicalTrials.gov Identifier: NCT03099382 |
Recruitment Status :
Completed
First Posted : April 4, 2017
Last Update Posted : October 25, 2019
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Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
Tracking Information | |||||
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First Submitted Date ICMJE | March 28, 2017 | ||||
First Posted Date ICMJE | April 4, 2017 | ||||
Last Update Posted Date | October 25, 2019 | ||||
Actual Study Start Date ICMJE | May 10, 2017 | ||||
Actual Primary Completion Date | May 6, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Overall Survival (OS) [ Time Frame: approximately 24 months ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of SHR-1210 Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal Cancer | ||||
Official Title ICMJE | A Phase III Randomized Open-Label Study of Single Agent SHR-1210 vs Investigator's Choice Standard Therapy in Subjects With Advanced/Metastatic Esophageal Cancer | ||||
Brief Summary | In this study, participants with advanced or metastatic squamous cell carcinoma of the esophagus that has progressed after first-line standard therapy will be randomized to receive either single agent SHR-1210 or the Investigator's choice of standard therapy with docetaxel or irinotecan. The primary study hypothesis is that treatment with SHR-1210 will prolong overall survival (OS) as compared to treatment with standard therapy. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Esophageal Carcinoma | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Huang J, Xu J, Chen Y, Zhuang W, Zhang Y, Chen Z, Chen J, Zhang H, Niu Z, Fan Q, Lin L, Gu K, Liu Y, Ba Y, Miao Z, Jiang X, Zeng M, Chen J, Fu Z, Gan L, Wang J, Zhan X, Liu T, Li Z, Shen L, Shu Y, Zhang T, Yang Q, Zou J; ESCORT Study Group. Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study. Lancet Oncol. 2020 Jun;21(6):832-842. doi: 10.1016/S1470-2045(20)30110-8. Epub 2020 May 13. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
457 | ||||
Original Estimated Enrollment ICMJE |
438 | ||||
Actual Study Completion Date ICMJE | May 6, 2019 | ||||
Actual Primary Completion Date | May 6, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03099382 | ||||
Other Study ID Numbers ICMJE | SHR-1210-III-301-ESC | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Jiangsu HengRui Medicine Co., Ltd. | ||||
Study Sponsor ICMJE | Jiangsu HengRui Medicine Co., Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Jiangsu HengRui Medicine Co., Ltd. | ||||
Verification Date | October 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |