Status:
RECRUITING
Evaluation of Stereotactic Body Radiotherapy as a Bridge Therapy for Hepatocellular Carcinoma Patients Enlisted for Liver Transplantation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this trial is to carry out the first prospective multicentric study which evaluates the efficacy and the safety of SBRT in HCC patients enlisted for LT and not suitable for other bridging i...
Detailed Description
Hypothesis for the study: The hypothesis is that SBRT in HCC patients enlisted for LT and not suitable to liver resection, RF, or TACE, is a safe and effective option to bring those patients to LT wh...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Patients enlisted for LT in France for HCC (under Agence de Biomédecine (ABM) regulation)
- HCC previously treated by ablation/surgery/TACE or naive
- Not suitable for another bridging therapy such as liver resection, ablation therapy, or TACE (discussed in multidisciplinary meeting within a transplant center)
- Suitable for stereotactic radiotherapy:
- ECOG, performance status score ≤ 2,
- Child-Pugh Score ≤ B7,
- Number of lesions between 1 and 3
- Maximum tumor size \< 5cm Liver remnant volume ≥ 700 ml.
- Health insurance coverage.
- Written informed consent
Exclusion
- Inability to comply with study procedures
- Patients under guardianship or curatorship
- Pregnancy (negative urinary/blood βHCG test)
Key Trial Info
Start Date :
May 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT06218420
Start Date
May 31 2024
End Date
September 1 2027
Last Update
June 4 2024
Active Locations (1)
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1
Service de chirurgie digestive, hépato-bilio-pancréatique et transplantation hépatique. Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013