Combination of Radiation Therapy and Anti-PD-1 Antibody SHR-1210 in Treating Patients With Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT03187314|
Recruitment Status : Unknown
Verified August 2017 by Shixiu Wu, Hangzhou Cancer Hospital.
Recruitment status was: Recruiting
First Posted : June 14, 2017
Last Update Posted : August 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Neoplasms Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms||Drug: Radiation Drug: SHR-1210||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Radiation Therapy With Anti-PD-1 Antibody SHR-1210 in Treating Patients With Unresectable Esophageal Cancer|
|Actual Study Start Date :||June 14, 2017|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Experimental Group
Radiation to 60 Gy, 5 x per week, for 6 weeks. Radiation begun the day after the first dose of SHR-1210. SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes.
RT to 60 Gy, 5 x per week，for 6 weeks. Radiation begun the day after the first dose of SHR-1210
SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes.
- Local control [ Time Frame: two years after enrollment ]occurrence of local or regional progression
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 3 months ]Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed by treatment-related adverse events assessed by CTCAE v4.0
- Objective response rate [ Time Frame: 3 months ]Objective response rate as assessed by RECIST criteria
- Overall survival [ Time Frame: 1 year ]Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187314
|Hangzhou Cancer Hospital||Recruiting|
|Hangzhou, Zhejiang, China, 310002|
|Contact: Shixiu Wu, MD +8657186826086 firstname.lastname@example.org|