Study of Fecal Microbiota Transplant with Atezolizumab and Bevacizumab for Unresectable Liver Cancer Patients Who Progressed After First-Line Treatment

What this Trial Is About

Researchers are evaluating whether adding fecal microbiota transplantation FMT to treatment with atezolizumab and bevacizumab can improve outcomes for people with unresectable hepatocellular carcinoma HCC whose cancer has worsened after initial therapy with these drugs. The study also aims to assess the safety and feasibility of combining FMT with these cancer drugs in this group. This is a Phase 2 interventional trial focusing on participants who have shown disease progression despite prior treatment. Participants will receive a fecal microbiota transplantation followed by resuming atezolizumab at a flat dose of 1200 mg and bevacizumab at 15 mgkg every three weeks. This treatment combination will be monitored as one experimental group, with treatments administered on a three-week cycle. The study will observe participants over approximately three years, including monitoring treatment response and adverse events. During the study, participants will undergo regular evaluations including scans to assess disease control at 12 weeks after FMT, along with continuous monitoring for serious side effects throughout the study period. Laboratory tests will be conducted within seven days prior to enrollment to confirm eligibility, and participants will be monitored for safety and treatment adherence. The main outcomes measured are disease control rate at 12 weeks and the incidence of severe adverse events over the study duration.

Fecal Microbiota Transplantation to RESCUE Patients With Unresectable Hcc Progressors to First Line Therapy With AtezolizUmaB and Bevacizumab