NCT07690683Not yet recruiting
Patients With Hepatocellular Carcinoma (HCC)
Fecal Microbiota Transplantation as a Response Booster in Patients With Hepatocellular Carcinoma Undergoing Immune Checkpoint Inhibitor Therapy
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 1 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07690683
What you commit to
- Study type: Interventional
- Planned participants: 52
- From 1 Sept 2026 to the primary completion date, 30 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent use of systemic antibiotics (within the previous 4-6 weeks);
Other illness
- Presence of chronic intestinal diseases (e.g., inflammatory bowel disease, celiac disease);
Other
- Child-Pugh class \> B8, ECOG performance status \>1;
- Any contraindication to colonoscopy.
Who the study is looking for
- Age \>18 years;
- Diagnosis of advanced or unresectable HCC;
- Patients undergoing standard therapy with immune checkpoint inhibitors (ICIs);
- Signed informed consent for study participation.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli, Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.