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

Recruiting now · Phase 2

Conditions studied: Hepato Cellular Carcinoma (HCC)

In brief

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 facts

Study ID

NCT07276100

Run by

IRCCS Azienda Ospedaliero-Universitaria di Bologna

People needed

15

Starts

2026-01-01

Expected to finish

2029-01-01

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed Informed Consent Form.
• Age ≥ 18 years.
• Tolerance to first-line treatment for HCC with atezolizumab plus bevacizumab, defined as absence of adverse events requiring permanent discontinuation of either drug.
• Ability to comply with all study procedures, in the investigator's judgment.
• Unresectable hepatocellular carcinoma with early disease progression on first-line atezolizumab + bevacizumab (within 4 months of treatment initiation).
• At least one untreated measurable lesion per RECIST 1.1.
• ECOG Performance Status 0-1.
• Child-Pugh class A.
• Adequate hematologic and end-organ function (laboratory values obtained within 7 days prior to enrollment), defined as follows:
• ANC ≥ 1.5 × 10⁹/L (1500/µL), without G-CSF support.
• Lymphocyte count ≥ 0.5 × 10⁹/L (500/µL).
• Platelet count ≥ 60 × 10⁹/L (60,000/µL), without transfusion.
• Hemoglobin ≥ 90 g/L (9 g/dL); transfusion allowed if last transfusion ≥ 3 weeks prior.
• AST, ALT, and ALP ≤ 5 × ULN.
• Total bilirubin ≤ 3 × ULN.
• Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault).
• Serum albumin ≥ 28 g/L (2.8 g/dL), without infusion supplementation in previous 2 months.
• INR and aPTT ≤ 1.5 × ULN.
• Women of childbearing potential:
• a. Agree to remain abstinent or use effective contraception (failure rate <1%/year) during treatment and for 5 months after last atezolizumab dose and 6 months after last bevacizumab dose.
• b. Agree to refrain from donating eggs during this period.
• Men with female partners of childbearing potential:
• Agree to remain abstinent or use a condom plus an additional contraceptive method (combined failure rate <1%/year) during treatment and for 6 months after last bevacizumab dose.
• Agree to refrain from donating sperm during this period.

You may not qualify if…

• History of leptomeningeal disease or brain metastases.
• Active or prior autoimmune disease or immune deficiency (e.g., myasthenia gravis, myositis, autoimmune hepatitis, SLE, RA, IBD, antiphospholipid syndrome, Wegener, Sjögren, Guillain-Barré, MS), except:
• Autoimmune hypothyroidism on replacement therapy.
• Controlled Type 1 diabetes on insulin.
• Dermatologic-only autoimmune diseases (eczema, psoriasis, lichen simplex chronicus, vitiligo) if:
• Rash <10% BSA. 2. Well-controlled on low-potency topical steroids. 3. No exacerbations requiring systemic therapy within 12 months.
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on CT (radiation pneumonitis in field allowed).
• Active tuberculosis.
• Significant cardiovascular disease within 3 months (NYHA ≥ II, MI, CVA), unstable arrhythmia, or unstable angina.
• Congenital long-QT syndrome or QTcF >500 ms at screening.
• Active advanced malignancy other than HCC within 1 year.
• Prior severe adverse reaction to atezolizumab or bevacizumab unmanageable with low-dose steroids or requiring discontinuation.
• Uncorrectable electrolyte abnormalities (K, Ca, Mg).
• Major surgery within 4 weeks or planned major surgery during study.
• Severe infection within 4 weeks (including hospitalization, bacteremia, severe pneumonia).
• Therapeutic oral/IV antibiotics within 2 weeks (prophylactic antibiotics allowed). All within 30 days has to be recorded in eCRF.
• Prior allogeneic stem cell or solid organ transplantation.
• Any condition or laboratory abnormality posing excessive risk or interfering with study results.
• Live attenuated vaccine within 4 weeks before treatment or planned during or 5 months after atezolizumab.
• Severe allergic or anaphylactic reaction to humanized antibodies or fusion proteins.
• Hypersensitivity to CHO cell products or components of atezolizumab or bevacizumab.
• Pregnancy or breastfeeding; intent to become pregnant during treatment or post-treatment windows.
• Pregnancy test required within 14 days pre-treatment.
• Fibrolamellar HCC, sarcomatoid HCC, or combined HCC-cholangiocarcinoma.
• Untreated or high-risk esophageal/gastric varices. EGD required; prophylactic treatment mandated.

Where it is running

• IRCCS AOU di Bologna Policlinico di Sant'Orsola — Bologna, BO, Italy (enrolling)

Full record on ClinicalTrials.gov

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