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

NCT ID: NCT04426955

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2023-12-31

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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm A

Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.

Group Type EXPERIMENTAL

Camrelizumab

Intervention Type DRUG

IV infusion

Paclitaxel

Intervention Type DRUG

IV infusion

Cisplatin

Intervention Type DRUG

IV infusion

Radiation

Intervention Type RADIATION

Concurrent Radiation

Arm B

Placebo + Paclitaxel + Cisplatin + Radiotherapy.

Group Type PLACEBO_COMPARATOR

Paclitaxel

Intervention Type DRUG

IV infusion

Cisplatin

Intervention Type DRUG

IV infusion

Placebo

Intervention Type DRUG

IV infusion

Radiation

Intervention Type RADIATION

Concurrent Radiation

Interventions

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Camrelizumab

IV infusion

Intervention Type DRUG

Paclitaxel

IV infusion

Intervention Type DRUG

Cisplatin

IV infusion

Intervention Type DRUG

Placebo

IV infusion

Intervention Type DRUG

Radiation

Concurrent Radiation

Intervention Type RADIATION

Other Intervention Names

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SHR-1210

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

1. Indicators of severe malnutrition;
2. A history of surgery for esophageal cancer;
3. Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
4. Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy;
5. Received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology therapies;
6. Active autoimmune diseases or history of autoimmune diseases that may relapse
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status

Countries

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China

Other Identifiers

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SHR-1210-III-323

Identifier Type: -

Identifier Source: org_study_id

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