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

Jiangsu HengRui Medicine Co., Ltd.396 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

396

Conditions

Esophageal Cancer

Interventions

CamrelizumabDRUG

IV infusion

PaclitaxelDRUG

IV infusion

CisplatinDRUG

IV infusion

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Outcomes

Primary Outcomes

PFS assessed by IRC

based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Time frame: up to 3 years

Secondary Outcomes

PFS assessed by investigators

based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

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.

Time frame: up to 3 years

ORR

based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Time frame: up to 3 years

DoR

based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Time frame: up to 3 years

adverse events

Time frame: up to 3 years

Data from ClinicalTrials.gov

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