Phase II Study Testing a Cancer Vaccine Combined With Atezolizumab and Bevacizumab for Unresectable Hepatocellular Carcinoma

What this Trial Is About

Researchers are evaluating the combination of a CD4 helper T-inducer cancer vaccine called UCPVax with anti-PD-L1 therapy atezolizumab and bevacizumab in patients with unresectable hepatocellular carcinoma HCC. This randomized Phase II trial aims to determine the clinical interest and immune response effectiveness by measuring the objective response rate at 6 months. The study involves 105 patients across 10 centers and is sponsored by the Centre Hospitalier Universitaire de Besancon. Participants are assigned to one of two groups one receiving atezolizumab plus bevacizumab combined with the UCPVax vaccine, and the other receiving only atezolizumab plus bevacizumab. Atezolizumab is given intravenously at 1200 mg every 3 weeks, bevacizumab at 15 mgkg every 3 weeks, and UCPVax vaccine is administered subcutaneously at 0.5 mg with an adjuvant. Treatment continues until disease progression or unacceptable side effects occur. During the study, patients will undergo regular assessments to evaluate tumor response using mRECIST guidelines at 6 months. Researchers will also monitor overall survival, progression-free survival, and disease control rate over approximately 2 years. Safety is closely followed through monitoring for adverse events and treatment tolerance. Participants overall health, performance status, and liver function will be evaluated throughout the study period.

Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma