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

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04426955
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    IV infusion
  • Paclitaxel — DRUG
    IV infusion
  • Cisplatin — DRUG
    IV infusion
  • Placebo — DRUG
    IV infusion
  • Radiation — RADIATION
    Concurrent Radiation

Study Details

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.

Key Dates

Start date
Jun 30, 2020
Status verified
Sep 2021
Primary completion
Dec 31, 2022
Completion
Dec 31, 2023

Study Design

Enrollment
396 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.
  • Placebo Comparator: Arm B
    Placebo + Paclitaxel + Cisplatin + Radiotherapy.

Primary Outcome Measure

PFS assessed by IRC [ Time Frame: up to 3 years ]

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