Status:
RECRUITING
Microbiota Modification for Immuno-oncology in Hepatocellular Carcinoma
Lead Sponsor:
Center Eugene Marquis
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Hepatocellular carcinoma (HCC) is the most common liver primary cancer with a high rate of mortality. Since the results of IMbrave150, immunotherapy have emerged as a standard of care for HCC patients...
Eligibility Criteria
Inclusion
- Male and Female
- Age ≥18 years at time of signing informed consent
- Presenting with HCC, diagnosed either by histological or radiological criteria as described by EASL
- Locally advanced or metastatic and/or unresectable HCC according a Multidisciplinary Team meeting
- Progressive disease after exposure to standard-of-care approved first-line immunotherapy
- Decision made by the physician to continue the same standard-of-care approved first-line immunotherapy beyond progression
- Child-Pugh A within 7 days prior to inclusion
- ECOG performance status 0 to 1
- Adequate hematological (Hemoglobin \>8.5g/dL, platelets \>60G/L, neutrophils \>1.5G/L) and renal (creatinine clearance \> 50 mL/min according to Cockcroft or MDRD formula) functions
- Disease measurable by RECIST 1.1
- Signed written Informed consent
Exclusion
- Partial response achieved under standard-of-care approved first-line immunotherapy
- CTCAE Grade ≥3 or more toxicity under standard-of-care approved first-line immunotherapy, or persistent toxicity Grade \>1
- Liver involvement \> 50%
- Presence of major macro vascular invasion (except Vp1/Vp2)
- Pregnant woman, or breastfeeding or women of child-bearing potential with no adequate contraception (see §4.3.1)
- Under curatorship, guardianship, safeguard of justice or deprived of liberty
- History of serious autoimmune disease
- Interstitial lung disease
- HBV chronic infection with HBV DNA \> 100 IU/mL or without antiviral therapy; HBV patients with cirrhosis should be treated
- HIV infection
- Immunosuppression, including subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg/day prednisone equivalent)
- Transplanted liver, or patient with intent for transplantation
- Has difficulties in swallowing.
- Has undergone major surgery or significant trauma ≤4 weeks prior to Screening. Note: Participants who had surgery \>4 weeks prior to Screening must have recovered adequately from any toxicity and/or complications from the surgery or trauma prior to starting study intervention.
- Is currently participating in or has participated in a study with an investigational compound or device within 3 months prior to the first dose of study intervention.
- Note: Participants who have entered the follow-up phase of an investigational study may participate so long as it has been at least 3 months since the last dose of the previous investigational agent.
- Has a systemic infection or other serious infection requiring systemic treatment within 30 days prior to Screening.
- Has a history of hypersensitivity to EXL01 and/or any excipients, which are listed in the IB, and/or to soybean or soy-containing products
- Has a history of hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies
- Active inflammatory intestinal disease (Crohn disease, Hemorrhagic recto-colitis, coeliac disease) or any serious chronic intestinal disease with uncontrolled diarrhea, or other inflammatory disease requiring anti-inflammatory medications
- Current probiotics administration, or planned probiotics administration during treatment course.
- Specific contra-indication to the continuation of the standard-of-care approved first-line immunotherapy :
- 1: for atezolizumab-bevacizumab:
- Thromboembolic events in the 3 months prior to inclusion
- Prior bleeding event due to untreated or incompletely treated esophageal and / or gastric varices within 6 months' prior inclusion
- Has a history of hypersensitivity to the atezolizumab or to any of the excipients listed in section 6.1 of the SmPC of atezolizumab
- Has a history of hypersensitivity to bevacizumab or to any of the excipients listed in section 6.1 of the SmPC of bevacizumab
- Uncontrolled hypertension
- Clinically significant cardiovascular disease such as pre-existing coronary artery disease, or congestive heart failure
- Proteinuria 21.2: for durvalumab:
- Has a history of hypersensitivity to the durvalumab or to any of the excipients listed in section 6.1 of the SmPC of durvalumab.
Key Trial Info
Start Date :
March 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06551272
Start Date
March 12 2025
End Date
December 12 2026
Last Update
August 5 2025
Active Locations (6)
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1
hôpital Avicenne
Bobigny, France, 93000
2
CHU de Bordeaux
Bordeaux, France
3
Hôpital Beaujon
Clichy, France, 92100
4
CHU de Nantes Hotel Dieu
Nantes, France, 44 000