Hepatocellular CarcinomaFORCENCT07690683
Patients With Hepatocellular Carcinoma (HCC)
A study testing Fecal microbiota transplantation performed via colonoscopy. in people with Hepatocellular Carcinoma and Hepatocellular Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatocellular Cancer, Liver Diseases
- What is being tested?
- Fecal microbiota transplantation performed via colonoscopy.
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years;
- Diagnosis of advanced or unresectable HCC;
- Patients undergoing standard therapy with immune checkpoint inhibitors (ICIs);
- Signed informed consent for study participation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli,
Roma
Francesca Romana Ponziani, 3471227242, francescaromana.ponziani@policlinicogemelli.it
Elisabetta Creta, 3480778584, elisabetta.creta@policlinicogemelli.it
About this study
Official title: Fecal Microbiota Transplantation as a Response Booster in Patients With Hepatocellular Carcinoma Undergoing Immune Checkpoint Inhibitor Therapy
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.
Read the detailed description
The study includes an initial screening phase aimed at assessing patient eligibility and obtaining written informed consent. Subsequently, participants will undergo centralized randomization through dedicated software, according to a procedure designed to maintain blinding for both patients and clinical staff involved in the study, with the exception of the technical personnel responsible for the preparation of fecal microbiota transplantation (FMT).
Throughout the study, both procedures included in standard clinical practice and procedures specifically required by the study protocol will be performed. Routine clinical activities will include the collection of clinical, laboratory, and instrumental data already planned within the standard patient care pathway. Laboratory monitoring will be carried out every 2-3 weeks and will include complete blood count, liver and renal function tests, C-reactive protein, urinalysis, and alpha-fetoprotein measurement. Radiological follow-up will be performed by CT scan every three months.
Regarding study-specific procedures, patients assigned to the experimental arm will receive fecal microbiota transplantation according to procedures designed to ensure maintenance of study blinding. Scheduled follow-up visits will take place at baseline and subsequently at 1, 6, and 12 months.
In addition to blood samples already collected as part of routine clinical practice, an extra 10 mL blood sample and two fecal samples will be collected from each patient at the predefined study timepoints, namely at enrollment and at months 1, 6, and 12. The analysis of biological samples, with particular focus on gut microbiota characterization and bile acid profiling, represents an important scientific investigational tool. These analyses may contribute to a better understanding of systemic inflammatory status and the pathophysiology of the gut-liver axis, potentially providing clinically relevant information for a more comprehensive and personalized long-term management of the disease.
Biological samples and patient data will be collected exclusively after obtaining written informed consent and in full compliance with the approval of the competent Territorial Ethics Committee.
Finally, the study includes prospective collection of clinical outcomes, including disease progression, radiological response according to RECIST 1.1/mRECIST criteria, and survival. Treatment efficacy will primarily be assessed in terms of progression-free survival (PFS), complemented by secondary endpoints including objective response rate (ORR), disease control rate (DCR), time to progression (TTP), and overall survival (OS).
- Being tested
- Fecal microbiota transplantation performed via colonoscopy., Simulated Colonoscopy With Placebo Capsules in Addition to Standard Treatment
- Keywords
- microbiota, fecal microbiota transplantation, FMT, immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation performed via colonoscopy.Procedure or surgery
Patients randomized to the intervention group will receive fecal microbiota transplantation (FMT) via colonoscopy.
Simulated Colonoscopy With Placebo Capsules in Addition to Standard TreatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Simulated Colonoscopy With Placebo Capsules in Addition to Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Time from randomization to documented disease progression or death from any cause.
Measured: 6-24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Romana Ponziani, Principal investigator, Fondazione Policlinico A. Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690683
- Sponsor's protocol ID
- 27533
- Acronym
- FORCE
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation as a Response Booster in Patients With Hepatocellular Carcinoma Undergoing Immune Checkpoint Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT07690683
- Acronym / sponsor ID
- FORCE / 27533
- Keywords
- microbiota, fecal microbiota transplantation, FMT, immunotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study includes an initial screening phase aimed at assessing patient eligibility and obtaining written informed consent. Subsequently, participants will undergo centralized randomization through dedicated software, according to a procedure designed to maintain blinding for both patients and clinical staff involved in the study, with the exception of the technical personnel responsible for the preparation of fecal microbiota transplantation (FMT).
Throughout the study, both procedures included in standard clinical practice and procedures specifically required by the study protocol will be performed. Routine clinical activities will include the collection of clinical, laboratory, and instrumental data already planned within the standard patient care pathway. Laboratory monitoring will be carried out every 2-3 weeks and will include complete blood count, liver and renal function tests, C-reactive protein, urinalysis, and alpha-fetoprotein measurement. Radiological follow-up will be performed by CT scan every three months.
Regarding study-specific procedures, patients assigned to the experimental arm will receive fecal microbiota transplantation according to procedures designed to ensure maintenance of study blinding. Scheduled follow-up visits will take place at baseline and subsequently at 1, 6, and 12 months.
In addition to blood samples already collected as part of routine clinical practice, an extra 10 mL blood sample and two fecal samples will be collected from each patient at the predefined study timepoints, namely at enrollment and at months 1, 6, and 12. The analysis of biological samples, with particular focus on gut microbiota characterization and bile acid profiling, represents an important scientific investigational tool. These analyses may contribute to a better understanding of systemic inflammatory status and the pathophysiology of the gut-liver axis, potentially providing clinically relevant information for a more comprehensive and personalized long-term management of the disease.
Biological samples and patient data will be collected exclusively after obtaining written informed consent and in full compliance with the approval of the competent Territorial Ethics Committee.
Finally, the study includes prospective collection of clinical outcomes, including disease progression, radiological response according to RECIST 1.1/mRECIST criteria, and survival. Treatment efficacy will primarily be assessed in terms of progression-free survival (PFS), complemented by secondary endpoints including objective response rate (ORR), disease control rate (DCR), time to progression (TTP), and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT arm | Experimental | Procedure: Fecal microbiota transplantation performed via colonoscopy.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. |
| control arm | Placebo comparator | Procedure: Simulated Colonoscopy With Placebo Capsules in Addition to Standard TreatmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years;
- Diagnosis of advanced or unresectable HCC;
- Patients undergoing standard therapy with immune checkpoint inhibitors (ICIs);
- Signed informed consent for study participation.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantation performed via colonoscopy.Patients randomized to the intervention group will receive fecal microbiota transplantation (FMT) via colonoscopy. | Procedure or surgery | FMT arm |
| Simulated Colonoscopy With Placebo Capsules in Addition to Standard TreatmentPatients 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. | Procedure or surgery | control arm |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 6-24 month
Time from randomization to documented disease progression or death from any cause.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca Romana Ponziani principal investigator
Fondazione Policlinico A. Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation performed via colonoscopy. in people with Hepatocellular Carcinoma and Hepatocellular Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Romana Ponziani (3471227242, francescaromana.ponziani@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 6-24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.