Patients With Hepatocellular Carcinoma (HCC)
Starting soon · Not applicable · Has a placebo group
Conditions studied: Hepatocellular Carcinoma, Hepatocellular Cancer, Liver Diseases, Liver Cancer
In brief
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 facts
- Study ID
- NCT07690683
- Run by
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- People needed
- 52
- Starts
- 2026-09-01
- Expected to finish
- 2029-09-01
- Last updated by the study team
- 2026-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >18 years;
- Diagnosis of advanced or unresectable HCC;
- Patients undergoing standard therapy with immune checkpoint inhibitors (ICIs);
- Signed informed consent for study participation.
You may not qualify if…
- 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.
Where it is running
- Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli, — Roma, Italy
Full record on ClinicalTrials.gov
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