Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07276100

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-12-10

15

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form.
  • Age 18 years or older.
  • Tolerated first-line treatment with atezolizumab plus bevacizumab without permanent discontinuation due to adverse events.
  • Able to comply with all study procedures.
  • Unresectable hepatocellular carcinoma with disease progression within 4 months of starting first-line atezolizumab and bevacizumab.
  • At least one measurable untreated 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 within 7 days prior to enrollment, including specific thresholds for ANC, lymphocytes, platelets, hemoglobin, liver enzymes, bilirubin, creatinine, albumin, INR, and aPTT.
  • Women of childbearing potential must agree to abstain or use effective contraception during treatment and specified post-treatment periods and refrain from egg donation.
  • Men with female partners of childbearing potential must agree to abstain or use condoms plus another contraceptive method during treatment and for 6 months after last bevacizumab dose, and refrain from sperm donation.
Not Eligible

You will not qualify if you...

  • History of leptomeningeal disease or brain metastases.
  • Active or prior autoimmune diseases or immune deficiency, except controlled autoimmune hypothyroidism, controlled type 1 diabetes, or certain well-controlled dermatologic autoimmune diseases.
  • History or evidence of active pneumonitis.
  • Active tuberculosis.
  • Significant cardiovascular disease within the last 3 months or unstable heart conditions.
  • Congenital long-QT syndrome or prolonged QTcF interval.
  • Active advanced malignancy other than hepatocellular carcinoma within 1 year.
  • Prior severe adverse reaction to atezolizumab or bevacizumab that cannot be managed.
  • Uncorrectable electrolyte abnormalities.
  • Recent major surgery or planned surgery during the study.
  • Severe infection or recent hospitalization.
  • Recent therapeutic antibiotics use within 2 weeks.
  • Prior stem cell or organ transplant.
  • Conditions or lab abnormalities posing excessive risk or interfering with study results.
  • Recent live attenuated vaccination.
  • Severe allergic reactions to study drugs.
  • Hypersensitivity to components of atezolizumab or bevacizumab.
  • Pregnancy or breastfeeding, or intent to become pregnant during study.
  • Fibrolamellar, sarcomatoid, or combined hepatocellular carcinoma.
  • Untreated or high-risk esophageal/gastric varices.
  • Recent variceal bleeding or clinically evident ascites.
  • Recent encephalopathy episode.
  • HBV/HCV co-infection.
  • Prior systemic therapy for advanced HCC other than first-line atezolizumab and bevacizumab.
  • Recent systemic immunostimulatory agents or immunosuppressive therapy.
  • Uncontrolled hypertension or significant vascular disease.
  • Recent hemoptysis or bleeding disorders.
  • Recent use of certain anticoagulants or antiplatelet agents at high doses.
  • Recent biopsy or surgery close to treatment start.
  • History of gastrointestinal fistula, perforation, or abscess within 6 months.
  • History or symptoms of intestinal obstruction requiring parenteral support.
  • Unexplained abdominal free air.
  • Non-healing wounds or untreated fractures.
  • Metastatic disease involving major airways or blood vessels.
  • Recent intra-abdominal inflammatory processes.
  • Recent radiotherapy or local liver therapy without recovery.
  • Chronic daily NSAID use other than low-dose aspirin.
  • Other specified conditions affecting safety or study integrity.

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, BO, Italy, 40138

Actively Recruiting

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Research Team

F

Fabio Piscaglia, MD

CONTACT

M

Mariarosaria Marseglia Biologist, Biologist

CONTACT

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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