For Healthcare Professionals

Phase 3 Study of Tislelizumab Versus Sorafenib in Participants With Unresectable HCC

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About the study

This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese participants. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese participants are recruited in this Phase 3 study.
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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

Key Inclusion Criteria:


  1. Histologically confirmed diagnosis of HCC
  2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach
  3. No prior systemic therapy for HCC (with the exception of HCC participants enrolled in the safety run-in substudy [Japan only])
  4. Measurable disease
  5. Child-Pugh score A
  6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  7. Adequate organ function

EXCLUSION CRITERIA

Key Exclusion Criteria:


  1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
  2. Tumor thrombus involving main trunk of portal vein or inferior vena cava
  3. Loco-regional therapy to the liver within 28 days before randomization
  4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization
  5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment
  6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse
  7. Participant with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization
  8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy
  9. QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening

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.

Study’s details


Contition

Hepatocellular Carcinoma (HCC)

Age (in years)

18+

Phase

Phase 3

Participants needed

674

Est. Completion Date

Dec 5, 2023

Treatment type

Interventional


Sponsor

BeiGene

ClinicalTrials.gov identifier

NCT03412773

Study number

BGB-A317-301

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