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BeiGene BGB-A317-301 (RATIONALE-301): A randomized, open-label, multicenter, phase 3 study to compare the efficacy and safety of BGB-A317 versus sorafenib as first-line treatment in patients with unresectable hepatocellular carcinoma (HCC)

Description

This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of BGB-A317 versus sorafenib as a first-line systemic treatment in patients with unresectable hepatocellular carcinoma.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this trial is to compare overall survival (OS) between tislelizumab and sorafenib as first-line treatment in patients with unresectable hepatocellular carcinoma (HCC).

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have histologically confirmed diagnosis of HCC
  • Have 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
  • Have no prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only])
  • Have measurable disease
  • Have Child-Pugh score A
  • Have Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  • Have adequate organ function

Excluding patients who:

  • Have known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
  • Have tumor thrombus involving main trunk of portal vein or inferior vena cava
  • Have loco-regional therapy to the liver within 28 days before randomization
  • Have clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within six months before randomization
  • Have bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at screening, or within six months before randomization/enrollment
  • Have presence at screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse
  • Have any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization
  • Have ahistory of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy
  • Have QT interval corrected for heart rate (corrected by Fridericia's method) > 450 msec at screening