Patients With Hepatocellular Carcinoma (HCC)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide and is frequently diagnosed at an advanced stage, resulting in limited therapeutic options. Despite the advances in immunotherapy, a substantial proportion of patients fail to respond adequately due to mechanisms of immune resistance. The gut microbiota plays a crucial role in modulating the response to immune checkpoint inhibitors (ICIs), and fecal microbiota transplantation (FMT) has demonstrated the ability to enhance their efficacy in other tumors, such as melanoma. In patients with HCC and cirrhosis, intestinal dysbiosis, characterized by a reduction in beneficial bacteria (e.g., Bifidobacterium, Akkermansia) and increased inflammation, is associated with an immunosuppressive profile. Furthermore, a dysbiosis index has been correlated with response to ICIs. In this context, FMT represents a promising strategy to enhance the efficacy of immunotherapy in HCC, although data regarding its efficacy and safety are still limited.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years;

Diagnosis of advanced or unresectable HCC;

Patients undergoing standard therapy with immune checkpoint inhibitors (ICIs);

Signed informed consent for study participation.

Disqualifiers

Presence of chronic intestinal diseases (e.g., inflammatory bowel disease, celiac disease);

Recent use of systemic antibiotics (within the previous 4-6 weeks);

Child-Pugh class > B8, ECOG performance status >1;

Any contraindication to colonoscopy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fecal microbiota transplantation performed via colonoscopy.

    Procedure/Surgery

    Patients randomized to the intervention group will receive fecal microbiota transplantation (FMT) via colonoscopy.

  • Simulated Colonoscopy With Placebo Capsules in Addition to Standard Treatment

    Procedure/Surgery

    Patients assigned to the control group will undergo a simulated (sham) colonoscopy and will subsequently follow the same therapeutic regimen with placebo capsules, in addition to standard therapy.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: FMT armExperimental treatment 1 intervention
Group B: control armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Time from randomization to documented disease progression or death from any cause.

Time frame
6-24 month

Secondary outcomes

Other outcomes

Sponsors and contacts

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