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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Zhejiang
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Hangzhou, Zhejiang, China, 310002
- Hangzhou Cancer Hospital
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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) 1.1.
- 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.
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.
- 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.
- Decision of unsuitableness by principal investigator or physician-in-charge.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective response rate (ORR)
Time Frame: 4-8 weeks
|
ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1.
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4-8 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment-emergent adverse events
Time Frame: year 0 - year 1
|
Incidence of treatment-emergent adverse events would be assessed based on the common toxicity criteria for adverse events version 4.0 (CTCAE v4.0) and EORTC criterion.
|
year 0 - year 1
|
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Local-regional free survival (LRFS)
Time Frame: year 0 - year 3
|
LRFS was calculated from the date of treatment initiation to the date of documented failure.
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year 0 - year 3
|
|
Overall survival
Time Frame: year 0 - year 3
|
OS was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.
|
year 0 - year 3
|
|
Health-related quality of life (HRQoL)
Time Frame: From baseline to one year after RT.
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HRQoL measured by standardized EORTC questionaires (EORTC QLQ-C30)
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From baseline to one year after RT.
|
|
Health-related quality of life (HRQoL)
Time Frame: From baseline to one year after RT.
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HRQoL measured by standardized EORTC questionaires (EORTC QLQ-OES18)
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From baseline to one year after RT.
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Neoplasms, Squamous Cell
- Carcinoma, Squamous Cell
- Esophageal Neoplasms
- Esophageal Squamous Cell Carcinoma
- Esophageal Diseases
Other Study ID Numbers
Other Study ID Numbers
- HangzhouCH08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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