Patients With Hepatocellular Carcinoma (HCC)

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Simulated Colonoscopy With Placebo Capsules in Addition to Standard Treatment: 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 summary

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

Primary outcome measure(s)

• Progression-Free Survival (PFS) — 6-24 month
  Time from randomization to documented disease progression or death from any cause.

Trial sites (1)

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