- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04426955
Study of Camrelizumab (SHR-1210) in Combination With Concurrent Chemoradiotherapy in Locally Advanced Esophageal Cancer
September 14, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Camrelizumab (SHR-1210) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of treatment with Camrelizumab (SHR-1210) + definitive chemoradiotherapy(dCRT) vs placebo+dCRT for locally advanced esophageal cancer patients in China.
Camrelizumab (SHR-1210) is a humanized anti-PD1 IgG4 monoclonal antibody.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
In this study, eligible subjects will be randomized into study arm or control arm.
Participants receive camrelizumab or placebo + chemotherapy + radiation therapy .
The chemotherapy regimens are : paclitaxel plus cisplatin Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) will be the primary outcomes.
Study Type
Interventional
Enrollment (Actual)
396
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tianjin, China
- Tianjin Medical University Cancer Institute and Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
1.18 to 75 years; 2.Histologically confirmed diagnosis of localized ESCC; 3.Measurable and/or non-measurable disease defined per RECIST v1.1; 4.ECOG Performance Status ≤ 1; 5.Adequate organ function
Exclusion Criteria:
- Indicators of severe malnutrition;
- A history of surgery for esophageal cancer;
- Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
- Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy;
- Received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology therapies;
- Active autoimmune diseases or history of autoimmune diseases that may relapse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.
|
IV infusion
IV infusion
IV infusion
Other Names:
Concurrent Radiation
|
Placebo Comparator: Arm B
Placebo + Paclitaxel + Cisplatin + Radiotherapy.
|
IV infusion
IV infusion
IV infusion
Concurrent Radiation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS assessed by IRC
Time Frame: up to 3 years
|
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
|
up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS assessed by investigators
Time Frame: up to 3 years
|
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
|
up to 3 years
|
OS
Time Frame: up to 3 years
|
OS is defined as the time from registration to death due to any cause, or censored at date last known alive.
Measured by the method of Kaplan and Meier.
|
up to 3 years
|
ORR
Time Frame: up to 3 years
|
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
|
up to 3 years
|
DoR
Time Frame: up to 3 years
|
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
|
up to 3 years
|
AE
Time Frame: up to 3 years
|
adverse events
|
up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2020
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
June 9, 2020
First Submitted That Met QC Criteria
June 9, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Actual)
September 16, 2021
Last Update Submitted That Met QC Criteria
September 14, 2021
Last Verified
September 1, 2021
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
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
Other Study ID Numbers
- SHR-1210-III-323
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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