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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Fecal microbiota transplantation (FMT)
Other interventionFecal microbiota transplantation (FMT)
Atezolizumab & Bevacizumab
DrugAtezolizumab \& Bevacizumab
Treatment groups
Trial outcomes
Primary outcomes
incidence of adverse events of grade > 3
disease control rate
Sponsors and contacts
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