Study of Irpagratinib Combined With Atezolizumab and Bevacizumab for Advanced or Unresectable Liver Cancer Showing FGF19 Overexpression

What this Trial Is About

This research evaluates the safety, tolerability, and preliminary effectiveness of a combination therapy using Irpagratinib, Atezolizumab, and Bevacizumab in patients with advanced or unresectable hepatocellular carcinoma HCC that shows FGF19 overexpression. It is a phase 2, open-label study with two parts a Safety Run-in to establish the appropriate dose of Irpagratinib within the triple therapy, and an Expansion phase to further assess safety and efficacy using a Simons two-stage design. During the Safety Run-in, nine patients will receive Irpagratinib orally at either 150 mg twice daily or 200 mg twice daily in repeated 21-day cycles, combined with Atezolizumab 1200 mg and Bevacizumab 15 mgkg intravenously every three weeks. Dose-limiting toxicities DLTs are monitored to determine the recommended Irpagratinib dose for the Expansion phase, where up to 24 patients will be treated with the selected dose of Irpagratinib plus Atezolizumab and Bevacizumab on the same schedule. Patients may continue treatment with the remaining drugs if they discontinue one due to adverse events but still benefit clinically. Participants will undergo regular assessments including imaging exams, laboratory tests, and clinical evaluations to monitor safety and response. The primary outcomes include the incidence of DLTs after the first cycle and the objective response rate evaluated over about 21 months. Secondary outcomes measure progression-free survival, disease control rate, duration of response, time to progression, overall survival, and adverse event incidence. Safety and efficacy data will be collected throughout the study, with follow-up visits up to one year after the last treatment dose.

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