Patients With Hepatocellular Carcinoma (HCC)

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT07690683
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fecal microbiota transplantation performed via colonoscopy. — PROCEDURE
    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
    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.

Study Details

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.

Key Dates

First listed
Jul 8, 2026
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FMT arm
    Fecal microbiota transplantation (FMT) will be administered by colonoscopy at the initiation of standard therapy, as part of routine clinical practice, followed by oral capsule administration in combination with standard treatment.
  • Placebo Comparator: control arm
    Patients assigned to the control arm will undergo a sham colonoscopy procedure, followed by administration of placebo capsules according to the same schedule, in combination with standard therapy.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 6-24 month ]

Central Contacts

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