Actively Recruiting
Fecal Microbiota Transplantation to RESCUE Patients With Unresectable Hepatocellular Carcinoma Progressing on First-Line Atezolizumab and Bevacizumab Therapy
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-06-01
15
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
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 mg/kg 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.
CONDITIONS
Brief Title
Fecal Microbiota Transplantation to RESCUE Patients With Unresectable Hcc Progressors to First Line Therapy With AtezolizUmaB and Bevacizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Age 18 years or older.
- Tolerated first-line treatment for HCC with atezolizumab plus bevacizumab without permanent drug discontinuation.
- Able to comply with all study procedures.
- Unresectable hepatocellular carcinoma with early disease progression on first-line atezolizumab plus bevacizumab within 4 months of starting treatment.
- At least one untreated measurable lesion per RECIST 1.1 criteria.
- ECOG Performance Status of 0 or 1.
- Child-Pugh class A liver function.
- Adequate blood counts and organ function based on laboratory tests within 7 days prior to enrollment.
- Women of childbearing potential must agree to effective contraception and abstain from egg donation during and after treatment.
- Men with female partners of childbearing potential must agree to effective contraception and abstain from sperm donation during and after treatment.
You will not qualify if you...
- History of leptomeningeal disease or brain metastases.
- Active or prior autoimmune disease or immune deficiency, except well-controlled hypothyroidism, controlled type 1 diabetes, or mild skin autoimmune conditions.
- History of lung diseases like idiopathic pulmonary fibrosis or current active pneumonitis.
- Active tuberculosis.
- Significant cardiovascular events within past 3 months or unstable heart conditions.
- Congenital long-QT syndrome or QTcF > 500 ms.
- Active advanced cancers other than HCC within 1 year.
- Severe adverse reactions to atezolizumab or bevacizumab that cannot be managed.
- Uncorrectable electrolyte imbalances.
- Major surgery within 4 weeks or planned during study.
- Severe infection within 4 weeks.
- Recent therapeutic oral or IV antibiotics within 2 weeks.
- Prior allogeneic stem cell or organ transplant.
- Any condition posing excessive risk or interfering with study results.
- Recent live attenuated vaccine within 4 weeks before or during treatment.
- Severe allergic reactions to similar drugs.
- Pregnancy or breastfeeding, or intent to become pregnant during treatment and follow-up.
- Certain types of HCC (fibrolamellar, sarcomatoid, combined HCC-cholangiocarcinoma).
- Untreated or high-risk esophageal/gastric varices.
- Recent variceal bleeding or ascites.
- Recent encephalopathy.
- HBV or HCV co-infection.
- Prior systemic therapy for advanced HCC other than first-line atezolizumab plus bevacizumab.
- Recent systemic immunostimulatory or immunosuppressive therapy.
- Uncontrolled hypertension or significant vascular disease recently.
- Recent bleeding issues or use of certain blood-thinning medications.
- Recent biopsy, surgery, or trauma as specified.
- History of gastrointestinal complications or untreated wounds.
- Metastatic disease involving major airways or blood vessels.
- Recent radiotherapy or local liver therapies within specified timeframes.
- Chronic daily NSAID use except low-dose aspirin.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing treatment cycles every 3 weeks until disease progression or discontinuation
Participants receive fecal microbiota transplantation combined with atezolizumab and bevacizumab every 3 weeks as treatment for unresectable hepatocellular carcinoma.
Repeated visits every 3 weeks
Trial Site Locations
Total: 1 location
1
IRCCS AOU di Bologna Policlinico di Sant'Orsola
Bologna, BO, Italy, 40138
Actively Recruiting
Research Team
F
Fabio Piscaglia, MD
M
Mariarosaria Marseglia Biologist, Biologist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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