Using Stereotactic Body Radiotherapy to Help Liver Transplant Patients with Hepatocellular Carcinoma
Evaluation of Stereotactic Body Radiotherapy as a Bridge Therapy for Hepatocellular Carcinoma Patients Enlisted for Liver Transplantation
This study is testing if a special type of radiation therapy can help liver transplant patients with liver cancer stay stable while they wait for their new liver.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 139 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Paris) |
| Trial ID | NCT06218420 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety and efficacy of Stereotactic Body Radiotherapy (SBRT) as a bridging therapy for patients with hepatocellular carcinoma (HCC) who are on the liver transplantation waiting list but are not suitable for other treatments like radiofrequency ablation or trans-arterial chemoembolization. The study aims to determine if SBRT can effectively control tumor progression while patients await liver transplantation. It is the first prospective multicentric study to assess this treatment approach in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with hepatocellular carcinoma who are enlisted for liver transplantation in France and not suitable for other bridging therapies.
Not a fit: Patients who are not eligible for liver transplantation or those who can undergo other effective bridging therapies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for HCC patients awaiting liver transplantation, potentially improving their chances of receiving a transplant.
How similar studies have performed: While this approach is novel in this specific context, similar studies using SBRT for other cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * Patients enlisted for LT in France for HCC or undergoing pre-transplant assessment (under Agence de Biomédecine (ABM) regulation) * HCC previously treated or naive * 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. The liver remnant volume will be measured at the baseline visit or M0. If the volume is \<700 ml, the patient will be in early discontinuation of the study. * Health insurance coverage. * Written informed consent Exclusion Criteria: * Inability to comply with study procedures * Patients under guardianship or curatorship * Pregnancy (Positiveurinary/blood βHCG test)
Where this trial is running
Paris
- Service de chirurgie digestive, hépato-bilio-pancréatique et transplantation hépatique. Groupe Hospitalier Pitié-Salpêtrière — Paris, France (Recruiting)
Study contacts
- Principal investigator: Claire GOUMARD, MD, PhD Assistant Professor — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Claire GOUMARD, MD, PhD Assistant Professor
- Email: claire.goumard@aphp.fr
- Phone: +33 6 07 77 39 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.