Patients With Hepatocellular Carcinoma (HCC)

NCT07690683 | Not Yet Recruiting

• 1 other identifier: 27533
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Cancer; Liver Diseases; Liver Cancer; Hepatocellular Carcinoma

Keywords

microbiota; fecal microbiota transplantation; FMT; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Time from randomization to documented disease progression or death from any cause.

  6-24 month

Study Arms (2)

FMT arm

EXPERIMENTAL

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.

Procedure: Fecal microbiota transplantation performed via colonoscopy.

control arm

PLACEBO COMPARATOR

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.

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

Interventions

Fecal microbiota transplantation performed via colonoscopy. PROCEDURE

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

FMT arm

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.

control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

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

Roma, Italy

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Liver Diseases

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases

Study Officials

• Francesca Romana Ponziani

  Fondazione Policlinico A. Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Romana Ponziani

CONTACT

3471227242; francescaromana.ponziani@policlinicogemelli.it

Elisabetta Creta

CONTACT

3480778584; elisabetta.creta@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 21, 2026

Record last verified: 2026-06

Locations

IT (1)