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

Hengrui Medicine

Status and phase: Unknown; Phase 3

Conditions: Esophageal Cancer

Treatments: Radiation: Radiation; Drug: Paclitaxel; Drug: Cisplatin; Drug: Camrelizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04426955

SHR-1210-III-323

Details and patient eligibility

About

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.

Full 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.

Enrollment: 396 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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396 participants in 2 patient groups, including a placebo group

Arm A

Experimental group

Description:

Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.

Treatment:

Drug: Camrelizumab

Drug: Cisplatin

Drug: Paclitaxel

Radiation: Radiation

Arm B

Placebo Comparator group

Description:

Placebo + Paclitaxel + Cisplatin + Radiotherapy.

Treatment:

Drug: Placebo

Drug: Cisplatin

Drug: Paclitaxel

Radiation: Radiation