Study of Camrelizumab (SHR-1210) in Combination With Concurrent Chemoradiotherapy in Locally Advanced Esophageal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: Camrelizumab
* Drug: Paclitaxel
* Drug: Cisplatin
* Drug: Placebo
* Radiation: Radiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy. | Drug: Camrelizumab<br>* IV infusion<br>* Other names: SHR-1210;Drug: Paclitaxel<br>* IV infusion<br>Drug: Cisplatin<br>* IV infusion<br>Radiation: Radiation<br>* Concurrent Radiation<br>|
| Placebo Comparator: Arm B<br>Placebo + Paclitaxel + Cisplatin + Radiotherapy. | Drug: Paclitaxel<br>* IV infusion<br>Drug: Cisplatin<br>* IV infusion<br>Drug: Placebo<br>* IV infusion<br>Radiation: Radiation<br>* Concurrent Radiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS assessed by IRC | 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 | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | up to 3 years | 
| OS | 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 | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | up to 3 years | 
| DoR | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | up to 3 years | 
| AE | adverse events | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD-1Antibody, locally advanced esophageal cancer