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Hepato Cellular Carcinoma (HCC)Phase 2NCT07276100

Fecal Microbiota Transplantation to RESCUE Patients With Unresectable Hcc Progressors to First Line Therapy With AtezolizUmaB and Bevacizumab

A Phase 2 study testing Fecal microbiota transplantation (FMT) and Atezolizumab & Bevacizumab in people with Hepato Cellular Carcinoma (HCC), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate whether fecal microbiota transplantation (FMT), when administered in combination with atezolizumab and bevacizumab, can improve treatment response in participants with hepatocellular carcinoma (HCC) whose disease has progressed during prior atezolizumab-bevacizumab therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepato Cellular Carcinoma (HCC)
What is being tested?
Fecal microbiota transplantation (FMT) and Atezolizumab & Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteItaly
Study dates
1 Jan 2026to 1 Jan 2029
Phase
Phase 2
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

  • Signed Informed Consent Form.
  • Age ≥ 18 years.
  • Tolerance to first-line treatment for HCC with atezolizumab plus bevacizumab, defined as absence of adverse events requiring permanent discontinuation of either drug.
  • Ability to comply with all study procedures, in the investigator's judgment.
  • Unresectable hepatocellular carcinoma with early disease progression on first-line atezolizumab + bevacizumab (within 4 months of treatment initiation).
  • At least one untreated measurable lesion per RECIST 1.1.
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  • ECOG Performance Status 0-1.
  • Child-Pugh class A.
  • Adequate hematologic and end-organ function (laboratory values obtained within 7 days prior to enrollment), defined as follows:
  • ANC ≥ 1.5 × 10⁹/L (1500/µL), without G-CSF support.
  • Lymphocyte count ≥ 0.5 × 10⁹/L (500/µL).
  • Platelet count ≥ 60 × 10⁹/L (60,000/µL), without transfusion.
  • Hemoglobin ≥ 90 g/L (9 g/dL); transfusion allowed if last transfusion ≥ 3 weeks prior.
  • AST, ALT, and ALP ≤ 5 × ULN.
  • Total bilirubin ≤ 3 × ULN.
  • Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault).
  • Serum albumin ≥ 28 g/L (2.8 g/dL), without infusion supplementation in previous 2 months.
  • INR and aPTT ≤ 1.5 × ULN.
  • Women of childbearing potential:
  • Agree to remain abstinent or use effective contraception (failure rate <1%/year) during treatment and for 5 months after last atezolizumab dose and 6 months after last bevacizumab dose.
  • Agree to refrain from donating eggs during this period.
  • Men with female partners of childbearing potential:
  • Agree to remain abstinent or use a condom plus an additional contraceptive method (combined failure rate <1%/year) during treatment and for 6 months after last bevacizumab dose.
  • Agree to refrain from donating sperm during this period.

Who cannot join

  • 1. History of leptomeningeal disease or brain metastases.
  • 2. Active or prior autoimmune disease or immune deficiency (e.g., myasthenia gravis, myositis, autoimmune hepatitis, SLE, RA, IBD, antiphospholipid syndrome, Wegener, Sjögren, Guillain-Barré, MS), except:
  • Autoimmune hypothyroidism on replacement therapy.
  • Controlled Type 1 diabetes on insulin.
  • Dermatologic-only autoimmune diseases (eczema, psoriasis, lichen simplex chronicus, vitiligo) if:
  • 1. Rash <10% BSA. 2. Well-controlled on low-potency topical steroids. 3. No exacerbations requiring systemic therapy within 12 months.
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  • 3. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on CT (radiation pneumonitis in field allowed).
  • 4. Active tuberculosis.
  • 5. Significant cardiovascular disease within 3 months (NYHA ≥ II, MI, CVA), unstable arrhythmia, or unstable angina.
  • 6. Congenital long-QT syndrome or QTcF >500 ms at screening.
  • 7. Active advanced malignancy other than HCC within 1 year.
  • 8. Prior severe adverse reaction to atezolizumab or bevacizumab unmanageable with low-dose steroids or requiring discontinuation.
  • 9. Uncorrectable electrolyte abnormalities (K, Ca, Mg).
  • 10. Major surgery within 4 weeks or planned major surgery during study.
  • 11. Severe infection within 4 weeks (including hospitalization, bacteremia, severe pneumonia).
  • 12. Therapeutic oral/IV antibiotics within 2 weeks (prophylactic antibiotics allowed). All within 30 days has to be recorded in eCRF.
  • 13. Prior allogeneic stem cell or solid organ transplantation.
  • 14. Any condition or laboratory abnormality posing excessive risk or interfering with study results.
  • 15. Live attenuated vaccine within 4 weeks before treatment or planned during or 5 months after atezolizumab.
  • 16. Severe allergic or anaphylactic reaction to humanized antibodies or fusion proteins.
  • 17. Hypersensitivity to CHO cell products or components of atezolizumab or bevacizumab.
  • 18. Pregnancy or breastfeeding; intent to become pregnant during treatment or post-treatment windows.
  • Pregnancy test required within 14 days pre-treatment.
  • 19. Fibrolamellar HCC, sarcomatoid HCC, or combined HCC-cholangiocarcinoma.
  • 20. Untreated or high-risk esophageal/gastric varices. EGD required; prophylactic treatment mandated.
  • 21. Variceal bleeding within 6 months.
  • 22. Clinically evident ascites.
  • 23. Episode of encephalopathy within 3 months.
  • 24. HBV/HCV co-infection.
  • 25. Patients with prior HCV but negative HCV RNA are considered non-infected.
  • 26. Prior systemic therapy for advanced HCC other than first-line atezolizumab + bevacizumab.
  • 27. Systemic immunostimulatory agents (e.g., interferon, IL-2) within 4 weeks or 5 half-lives.
  • 28. Symptomatic, untreated, or actively progressing CNS metastases. Eligible only if all criteria are met: extracranial measurable disease, no hemorrhage history, lesions limited to cerebellum/supratentorial region, no progression post-therapy, no recent RT/surgery, no steroid requirement, stable anticonvulsants, new lesions treated before enrollment.
  • 29. Uncontrolled tumor-related pain; symptomatic lesions requiring RT must be treated first.
  • 30. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring ≥ monthly drainage.
  • Indwelling catheters allowed.
  • 31. Uncontrolled or symptomatic hypercalcemia.
  • 32. Investigational therapy (other than atezolizumab + bevacizumab) within 28 days.
  • 33. Systemic immunosuppressive therapy within 2 weeks, except:
  • Acute, low-dose, or one-time pulse steroids.
  • Mineralocorticoids, inhaled steroids, low-dose steroids for adrenal insufficiency/orthostatic hypotension.
  • 34. Uncontrolled hypertension (SBP >150 mmHg and/or DBP >100 mmHg on multiple readings).
  • 35. Prior hypertensive crisis or hypertensive encephalopathy.
  • 36. Significant vascular disease within 6 months.
  • 37. Hemoptysis >2.5 mL within 1 month.
  • 38. Bleeding diathesis or significant coagulopathy.
  • 39. Current or recent (within 10 days of first dose of study treatment) use of aspirin >325 mg/day or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.
  • 40. Current or recent (within 10 days prior to study treatment start) use of full dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose. Prophylactic anticoagulation for the patency of venous access devices is allowed provided the activity of the agent results in an INR < 1.5 x ULN and aPTT is within normal limits (ratio <1.5) within 14 days prior to initiation of study treatment.
  • 41. Core biopsy or minor surgery (except vascular access) within 3 days of first bevacizumab dose.
  • 42. History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess within 6 months.
  • 43. History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including subocclusive disease related to the underlying disease or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding prior to initiation of study treatment. Patients with signs/symptoms of sub-/occlusive syndrome/intestinal obstruction at time of initial diagnosis may be enrolled if they had received definitive (surgical) treatment for symptom resolution.
  • 44. Abdominal free air not explained by procedure or surgery.
  • 45. Serious non-healing wound, ulcer, or untreated bone fracture.
  • 46. Metastatic disease involving major airways/blood vessels or large mediastinal masses (<30 mm from carina).
  • Portal/hepatic vein invasion allowed.
  • 47. Intra-abdominal inflammatory process (e.g., complicated PUD, diverticulitis, colitis) within 6 months.
  • 48. Radiotherapy within 28 days (or abdominal/pelvic RT within 60 days), except palliative bone RT within 7 days.
  • 49. Local liver therapy (RFA, ethanol, cryoablation, HIFU, TACE, TAE, SIRT) within 28 days or incomplete recovery.
  • 50. Major surgery, open biopsy, abdominal surgery, abdominal intervention, or significant trauma within the specified windows or unresolved from such events.
  • 51. Chronic daily NSAID use, except aspirin <325 mg/day. Occasional use allowed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fabio Piscaglia, MD contact

0512142214

fabio.piscaglia@unibo.it

Mariarosaria Marseglia Biologist, Biologist contact

mariarosaria.marseglia@aosp.bo.it

Italy1 site, 1 recruiting

  • IRCCS AOU di Bologna Policlinico di Sant'Orsola

    Bologna, BO, 40138

    Prof. Piscaglia, MD, 0512142214, fabio.piscaglia@unibo.it

    Recruiting

Other trials in Italy

About this study

The purpose of this study is to evaluate whether fecal microbiota transplantation (FMT), when administered in combination with atezolizumab and bevacizumab, can improve treatment response in participants with hepatocellular carcinoma (HCC) whose disease has progressed during prior atezolizumab-bevacizumab therapy. The study will also assess the safety and feasibility of this treatment strategy.

Primary Objective:

To determine whether FMT can restore or enhance response to atezolizumab and bevacizumab following disease progression.

Participants will:

Receive a fecal microbiota transplantation (FMT).

Resume treatment with atezolizumab and bevacizumab, administered every 3 weeks.

Being tested
Fecal microbiota transplantation (FMT), Atezolizumab & Bevacizumab
Keywords
hepato cellular carcinoma, atezolizumab, microbiota, fecal microbiota trasplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal microbiota transplantation (FMT)Other

    Fecal microbiota transplantation (FMT)

  • Atezolizumab & BevacizumabDrug

    Atezolizumab \& Bevacizumab

Study groups in NCT07276100
Study groupRoleWhat they receive
experimentalExperimentalFecal microbiota transplantation (FMT) + atezolizumab (1200 mg flat dose) and bevacizumab (15 mg/kg) Q3W
Receives: Other: Fecal microbiota transplantation (FMT); Drug: Atezolizumab & Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of adverse events of grade > 3

    Measured: through study completion, approximately 3 years

  2. disease control rate

    Measured: 12 weeks after FMT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2025
  2. Study start1 Jan 2026
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2029 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07276100
Sponsor's protocol ID
RESCUE-HUB
Other IDs
2023-510504-45-00, 2023
Status last verified
May 2026
First submitted
25 Nov 2025
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fecal microbiota transplantation (FMT) and Atezolizumab & Bevacizumab in people with Hepato Cellular Carcinoma (HCC), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 24 inclusion and 60 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: looking for participants now, as of the sponsor's last update on 1 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Fabio Piscaglia, MD (0512142214, fabio.piscaglia@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of adverse events of grade > 3 (time frame: through study completion, approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07276100.

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 1 Jun 2026.

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