A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

Part of paid clinical trials in Detroit, Michigan.

Sponsor
BeiGene
Study ID
NCT03430843
Phase
PHASE3
Status
Completed

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab — DRUG
    200 mg administered intravenously (IV)
  • Paclitaxel — DRUG
    135-175 mg /m² administered IV , or 80-100 mg/m\^2 administered IV according to local guidelines for standard of care
  • Docetaxel — DRUG
    75 mg/m\^2 administered IV or 70 mg/m\^2 IV in Japan
  • Irinotecan — DRUG
    125 mg/m\^2 administered IV

Study Details

The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.

Key Dates

Start date
Jan 26, 2018
Status verified
Oct 2024
Primary completion
Dec 1, 2020
Completion
Dec 28, 2022

Study Design

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

Arms

  • Experimental: Tislelizumab
    Tislelizumab on Day 1, given every 21 days
  • Active Comparator: Investigator chosen chemotherapy (ICC)
    Paclitaxel on Day 1, given every 21 days or on a weekly schedule; OR Docetaxel on Day 1, given every 21 days; OR Irinotecan on Days 1 and 8, given every 21 days

Primary Outcome Measure

Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set [ Time Frame: Approximately 2 years and 10 months from date of first randomization ]

Locations (2)

FacilityCityStateZIPSite coordinators
Henry Ford HospitalDetroitMichigan48202-
Toledo Clinic Cancer CenterToledoOhio43623-

Find similar trials in Detroit, MI

By research site
Henry Ford Hospital· Detroit, MIToledo Clinic Cancer Center· Toledo, OH

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