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New treatment option for Hepato Cellular Carcinoma (HCC)
Official title Fecal Microbiota Transplantation to RESCUE Patients With Unresectable Hcc Progressors to First Line Therapy With AtezolizUmaB and Bevacizumab
ClinicalTrials.gov ID: NCT07276100
What this study is testing
What is Atezolizumab & Bevacizumab?
Atezolizumab & Bevacizumab is an investigational medicine, being studied as a potential treatment for hepato cellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 1\. History of leptomeningeal disease or brain metastases. 2\. Active or prior autoimmune disease or immune deficiency (e.g., myasthenia gravis...
- Autoimmune hypothyroidism on replacement therapy.
- Controlled Type 1 diabetes on insulin.
- Dermatologic-only autoimmune diseases (eczema, psoriasis, lichen simplex chronicus, vitiligo) if: 1\. Rash \ 500 ms at screening. 7\. Active advanced...
- Acute, low-dose, or one-time pulse steroids.
- Mineralocorticoids, inhaled steroids, low-dose steroids for adrenal insufficiency/orthostatic hypotension. 34\. Uncontrolled hypertension (SBP \>150...
See the full eligibility criteria
- 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.
- 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: a. 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...
- 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.
- 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...
- Autoimmune hypothyroidism on replacement therapy.
- Controlled Type 1 diabetes on insulin.
- Dermatologic-only autoimmune diseases (eczema, psoriasis, lichen simplex chronicus, vitiligo) if: 1\. Rash \ 500 ms at screening. 7\. Active advanced malignancy other than HCC within 1 year. 8\. Prior severe adverse...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, BO, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, BO, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.