Combination of Radiation Therapy and Anti-PD-1 Antibody SHR-1210 in Treating Patients With Esophageal Cancer
Phase II Study of Radiation Therapy With Anti-PD-1 Antibody SHR-1210 in Treating Patients With Unresectable Esophageal Cancer
1 other identifier
interventional
25
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedStudy Start
First participant enrolled
June 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedAugust 17, 2020
August 1, 2020
2 years
June 13, 2017
August 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR)
ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1.
4-8 weeks
Secondary Outcomes (5)
Treatment-emergent adverse events
year 0 - year 1
Local-regional free survival (LRFS)
year 0 - year 3
Overall survival
year 0 - year 3
Health-related quality of life (HRQoL)
From baseline to one year after RT.
Health-related quality of life (HRQoL)
From baseline to one year after RT.
Study Arms (1)
Experimental Group
EXPERIMENTALRadiation 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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) 1.1.
- Can provide either a newly obtained or archival tumor tissue sample.
- ECOG 0-1.
- 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-1210.
- Patient has given written informed consent.
You may not qualify if:
- 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.
- Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 formulation.
- Concurrent medical condition requiring the use of cortisol (\>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treament. Except: inhalation or topical corticosteroids. Doses \> 10 mg/day prednisone or equivalen for replacement therapy.
- Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent.
- Received a live vaccine within 4 weeks of the first dose of study medication.
- Pregnancy or breast feeding.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hangzhou Cancer Hospitallead
- Jiangsu HengRui Medicine Co., Ltd.collaborator
Study Sites (1)
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310002, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 13, 2017
First Posted
June 14, 2017
Study Start
June 14, 2017
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
August 17, 2020
Record last verified: 2020-08