NCT04426955

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 396 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab	IV infusion
DRUG	Paclitaxel	IV infusion
DRUG	Cisplatin	IV infusion
DRUG	Placebo	IV infusion
RADIATION	Radiation	Concurrent Radiation

Timeline

• Start date: 2020-06-30
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2020-06-11
• Last updated: 2021-09-16

Locations

1 site across 1 country: China