A Prospective Study to Evaluate the Safety and Efficacy of the Combination Therapy of Irpagratinib, Atezolizumab, and Bevacizumab in Patients With Hepatocellular Carcinoma

This is a phase 2, open-label study to evaluate the safety, tolerability and efficacy of Irpagratinib in combination with Atezolizumab and Bevacizumab in patients with advanced or unresectable HCC harboring FGF19 overexpression. This study composes two parts, a Safety Run-in part to evaluate safety and establish the dose of Irpagratinib for the triple combination, and an Expansion part to evaluate the preliminary efficacy and safety using Simon's two-stage design.

Trial Details

NCT ID
NCT07010497
Phase
PHASE2
Sponsor
Asan Medical Center
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • irpagratinib
Locations (sample)
  • Seoul, South Korea|37.566,126.9784
  • Seoul, South Korea|37.566,126.9784
  • Seoul, South Korea|37.566,126.9784

Key Eligibility Criteria

  • Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient …
  • Male or female, aged ≥19 at the time of signing inform consent form.
  • Patients must have histological or cytological confirmed advanced or unresectable HCC not amenable to curative surgical or loco-regional therapies.…
  • Provide archived tissue sample for FGF19 overexpression detection.For Safety-Run in and Expansion: the result of FGF19 overexpression lab testing m…

For full eligibility, visit ClinicalTrials.gov.

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