Phase II Study of Radiation Therapy With Anti-PD-1 Antibody SHR-1210 in Treating Patients With Unresectable Esophageal Cancer

Hangzhou Cancer Hospital1 site in 1 country25 target enrollmentJune 14, 2017

ConditionsEsophageal Neoplasms Esophageal Diseases Esophageal Squamous Cell Carcinoma

InterventionsRadiation SHR-1210

DrugsRadiation SHR-1210

Overview

Phase: Phase 2
Intervention: Radiation
Conditions: Esophageal Neoplasms
Sponsor: Hangzhou Cancer Hospital
Enrollment: 25
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in patients with esophageal cancer

Registry

clinicaltrials.gov

Start Date

June 14, 2017

End Date

June 30, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hangzhou Cancer Hospital

Responsible Party

Principal Investigator

Shixiu Wu

Professor

Hangzhou Cancer Hospital

Eligibility Criteria

Inclusion Criteria

•age:18-75 years, male or femal.
•Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease.
•Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.
•Can provide either a newly obtained or archival tumor tissue sample.
•Life expectancy of greater than 12 weeks.
•Adequate organ function.
•Female: child bearing potential, a negative urine or serum pregnancy test result within 72 h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 3 months after the last dose of SHR-
•Patient has given written informed consent.

Exclusion Criteria

•Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
•Complete obstruction of the esophagus, or patients who have the potential to develop perforation
•Other malignancy within 5 years prior to entry into the study, expect for curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.
•Known central nervous system (CNS) metastases.
•Subjects with any active autoimmune disease or history of autoimmune disease.
•Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
•Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
•History of Interstitial Pneumonia or active non-infectious pneumonitis.
•Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C.
•Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.

Arms & Interventions

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.

Intervention: Radiation