Study of SHR-1210 Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT03099382
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • camrelizumab — BIOLOGICAL
    Subjects receive camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks
  • Docetaxel — DRUG
    Subjects receive Docetaxel intravenous infusion at the dose 75mg/m2 on Day 1 every 3 weeks
  • Irinotecan — DRUG
    Subjects receive Irinotecan intravenous infusion at the dose 180mg/m2 on Day 1 every 2 weeks

Study Details

In this study, participants with advanced or metastatic squamous cell carcinoma of the esophagus that has progressed after first-line standard therapy will be randomized to receive either single agent SHR-1210 or the Investigator's choice of standard therapy with docetaxel or irinotecan. The primary study hypothesis is that treatment with SHR-1210 will prolong overall survival (OS) as compared to treatment with standard therapy.

Key Dates

Start date
May 5, 2017
Status verified
Apr 2023
Primary completion
May 6, 2019
Completion
May 6, 2019

Study Design

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

Arms

  • Experimental: camrelizumab
  • Active Comparator: Investigator's Choice of Standard Therapy
    Docetaxel or Irinotecan

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: approximately 24 months ]

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