Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Liver Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fecal microbiota transplantation performed via colonoscopy. | Procedure | — | UNRESOLVED |
| Simulated Colonoscopy With Placebo Capsules in Addition to Standard Treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FMT arm
- description
- 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.
- interventionNames
- Procedure: Fecal microbiota transplantation performed via colonoscopy.
- type
- PLACEBO_COMPARATOR
- label
- control arm
- description
- 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.
- interventionNames
- Procedure: Simulated Colonoscopy With Placebo Capsules in Addition to Standard Treatment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available