Study of IBI308 With Advanced/Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-line Treatment

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT03116152
Phase
PHASE2
Status
Completed

Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • IBI308 — BIOLOGICAL
    IBI308 200mg Intravenous drip every three weeks；
  • paclitaxel/ irinotecan — DRUG
    paclitaxel 175mg/㎡ Intravenous drip every three weeks or irinotecan 180mg/㎡ Intravenous drip every two weeks

Study Details

Efficacy and safety evaluation of IBI308 versus paclitaxel/irinotecan in patients with advanced/metastatic esophageal squamous cell carcinoma after failure of first-line treatment: a randomized, open-label, multicenter, phase 2 study

Key Dates

Start date
May 10, 2017
Status verified
Jan 2021
Primary completion
Oct 2, 2019
Completion
Oct 2, 2019

Study Design

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

Arms

  • Experimental: IBI308
    IBI308 200mg Intravenous drip every three weeks
  • Active Comparator: paclitaxel/irinotecan
    paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks

Primary Outcome Measure

Overall Survival [ Time Frame: Through Final Analysis data cutoff date of 2-August-2019 (up to approximately 26 months) ]

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