Study of SHR-1210 Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal Cancer
A Randomized, Open-Label, Active-Controlled, Multi-Center, Phase III Clinical Study of Anti-PD-1 Antibody SHR-1210 vs. Investigator's Choice of Chemotherapy in Subjects With Locally Advanced or Metastatic Esophageal Cancer
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
Beijing
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Beijing, Beijing, China
- Cancer Hospital Chinese Academy of Medical Sciences
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Beijing, Beijing, China
- 307 Hospital of PLA
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age: 18-75 years, male or female.
- Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease, recurrent or Metastatic disease.
- Fail to the first-line standard therapy.
- 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 or through 180 days after the last dose of docetaxel or irinotecan.
- Patient has given written informed consent.
Exclusion Criteria:
- Has a known additional malignancy within the last 5 years before study treatment with the exception of 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 before two weeks of randomization (subjects with tumor fever may be enrolled at the discretion of the investigator);
- History of Interstitial Pneumonia or received Corticosteroids for non-infectious pneumonitis.
- Known Human Immunodeficiency Virus (HIV) infection, active Hepatitis B or Hepatitis C.
- BMI, <18.5mg/m2 or ≥10% weight lost before screening.
- 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, allergy, hypersensitivity, or contraindication to docetaxel, or irinotecan.
- 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 treatment. Except: inhalation or topical corticosteroids. Doses > 10 mg/day prednisone or equivalent 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.
- Currently participating or has participated in a study within 4 weeks of the first dose of study medication.
- Received a live vaccine within 4 weeks of the first dose of study medication.
- Pregnancy or breast feeding.
- According to the investigator, other conditions that may lead to stop the research.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: camrelizumab
|
Subjects receive camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks
Other Names:
|
|
Active Comparator: Investigator's Choice of Standard Therapy
Docetaxel or Irinotecan
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Subjects receive Docetaxel intravenous infusion at the dose 75mg/m2 on Day 1 every 3 weeks
Subjects receive Irinotecan intravenous infusion at the dose 180mg/m2 on Day 1 every 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Survival (OS)
Time Frame: approximately 24 months
|
approximately 24 months
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
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
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Docetaxel
- Irinotecan
Other Study ID Numbers
Other Study ID Numbers
- SHR-1210-III-301-ESC
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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