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Not Yet Recruiting NCT07690683

Patients With Hepatocellular Carcinoma (HCC)

Conditions: Hepatocellular Carcinoma, Hepatocellular Cancer, Liver Diseases, Liver Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 52
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Location: Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli, Roma

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 Criteria

Inclusion Criteria: * Age \>18 years; * Diagnosis of advanced or unresectable HCC; * Patients undergoing standard therapy with immune checkpoint inhibitors (ICIs); * Signed informed consent for study participation. Exclusion Criteria: * 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07690683). StuddyBuddy aggregates publicly available trial information.