For Healthcare Professionals

Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Chemoradiotherapy in Participant With ESCC

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About the study

This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of BGB-A317 versus P placebo with chemoradiotherapy in participants with Localized Esophageal Squamous Cell Carcinoma.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. 18 to 75 years on the day of signing the informed consent form
  2. Histologically confirmed diagnosis of localized ESCC
  3. Measurable and/or non-measurable disease defined per RECIST v1.1
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  5. Adequate organ function Key

EXCLUSION CRITERIA

  1. Indicators of severe malnutrition
  2. Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 2 weeks prior to randomization
  3. Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy
  4. Received prior radiotherapy or therapies targeting PD-1, PD-L1, PD-L2 or other immune-oncology therapies
  5. Active autoimmune diseases or history of autoimmune diseases that may relapse NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 4008203159Email iconEmail Study Center

Study’s details


Contition

Esophageal Squamous Cell Carcinoma (ESCC)

Age

18+

Phase

Phase 3

Participants needed

370

Est. Completion Date

Dec 2024

Treatment type

Interventional


Sponsor

BeiGene

ClinicalTrials.gov identifier

NCT03957590

Study number

BGB-A317-311

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