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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Autoimmune hypothyroidism on replacement therapy.

Controlled Type 1 diabetes on insulin.

Acute, low-dose, or one-time pulse steroids.

Mineralocorticoids, inhaled steroids, low-dose steroids for adrenal insufficiency/orthostatic hypotension.

Trial design

Design model

Single group

Treatments tested in this trial

  • Fecal microbiota transplantation (FMT)

    Other intervention

    Fecal microbiota transplantation (FMT)

  • Atezolizumab & Bevacizumab

    Drug

    Atezolizumab \& Bevacizumab

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: experimentalExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

incidence of adverse events of grade > 3

Time frame
through study completion, approximately 3 years
2

disease control rate

Time frame
12 weeks after FMT

Secondary outcomes

Other outcomes

Sponsors and contacts

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