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

Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study ID
NCT07276100
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hepato Cellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fecal microbiota transplantation (FMT) — OTHER
    Fecal microbiota transplantation (FMT)
  • Atezolizumab & Bevacizumab — DRUG
    Atezolizumab \& Bevacizumab

Study Details

The purpose of this study is to evaluate whether fecal microbiota transplantation (FMT), when administered in combination with atezolizumab and bevacizumab, can improve treatment response in participants with hepatocellular carcinoma (HCC) whose disease has progressed during prior atezolizumab-bevacizumab therapy. The study will also assess the safety and feasibility of this treatment strategy. Primary Objective: To determine whether FMT can restore or enhance response to atezolizumab and bevacizumab following disease progression. Participants will: Receive a fecal microbiota transplantation (FMT). Resume treatment with atezolizumab and bevacizumab, administered every 3 weeks.

Key Dates

Start date
Jan 1, 2026
Status verified
May 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: experimental
    Fecal microbiota transplantation (FMT) + atezolizumab (1200 mg flat dose) and bevacizumab (15 mg/kg) Q3W

Primary Outcome Measure

incidence of adverse events of grade > 3 [ Time Frame: through study completion, approximately 3 years ]

Central Contacts