Evaluation of Stereotactic Body Radiotherapy as a Bridge Therapy for Hepatocellular Carcinoma Patients Enlisted for Liver Transplantation

NCT06218420 | Recruiting Phase 2 DMC

• 1 other identifier: APHP210358
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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 interventional treatments (RF or TACE). The incidence of hepatocellular carcinoma (HCC) is increasing worldwide and is currently the first indication for Liver transplantation (LT). HCC patients access to LT is not only determined by the underlying liver function but also by the alpha-fetoprotein (aFP) score which allows to better identify patients with high risk of recurrence. LT is the best curative treatment as it can cure both the tumor and the underlying liver disease. However, the access to LT is limited due to organ shortage and preserved liver function for the majority of the patients with HCC. Bridging therapies, such as ablation by radiofrequency (RF) or microwaves, or trans-arterial chemoembolization (TACE), are carried out routinely to prevent the risk of tumor progression and drop-out during the waiting time (the drop-out rate being 20%). Nevertheless, only 50 to 70% of patients in France will have access to these treatments due to specific contraindications. Stereotactic body radiotherapy (SBRT) has emerged as a non-invasive alternative and potentially efficient treatment of single or bilocular HCC. SBRT is a high-precision technique allowing to deliver a precise high dose irradiation on moving intrahepatic lesions. RTS is feasible only when the hepatic reserve is sufficient to avoid radic hepatitis. Advantages of SBRT, as compared to TACE or RF, are 1) to preserve the hepatic artery, which can be altered by TACE 2) to allow access to complex tumors locations or superficial lesions not feasible by RF 3) to avoid any tumor spread related to punctures 4) to avoid general anesthesia. However, SBRT has not been validated as bridging therapy before LT in a prospective study. Thus, this study is the first prospective multicentric study to evaluate this treatment modality in HCC patients enlisted for LT not suitable to RF or TACE.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; liver transplantation; bridging treatment; stereotactic body radiation therapy

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of stereotactic body radiotherapy (SBRT) as bridging therapy for patients with hepatocellular carcinoma (HCC) enlisted for liver transplantation (LT).

  Bridge therapy success is defined as follows: * Patient with liver transplantation within 15 months after the first session SBRT or, * Patient still enlisted (ie with aFP score\<2) at M15 from the first session SBRT. All other cases will be considered as failure.

  Within 15 months following SBRT.

Secondary Outcomes (4)

• To estimate the overall and disease-free survival after LT for HCC treated with SBRT on waiting list

  Up to 24 months post LT

• To evaluate the pathological response after SBRT on the liver explant after LT

  After LT surgery (maximum 39 months after inclusion and within 24 months post LT).

• To assess the performance of liver imaging (using RECIST 1.1, mRECIST) to predict the pathological response

  Preceding LT surgery (and within 15 months after inclusion at maximum)

• To assess the occurrence of adverse events related to SBRT during waiting time period and after LT

  Before and after LT (maximum 39 months after inclusion and within 24 months post LT)

Study Arms (1)

Patients with hepatocellular carcinoma enlisted for a liver transplant and eligible for SBRT

OTHER

All patients enrolled in the trial and responding to inclusion/exclusion criteria will receive SBRT (a high-precision technique allowing to deliver a precise high dose irradiation on moving intrahepatic lesions).

Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Stereotactic Body Radiotherapy (SBRT) RADIATION

Stereotactic Body Radiotherapy (SBRT) is a non-invasive alternative and potentially efficient treatment of single or bilocular HCC. However, SBRT has not been validated as bridging therapy before LT in a prospective study yet.

Patients with hepatocellular carcinoma enlisted for a liver transplant and eligible for SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to comply with study procedures
• Patients under guardianship or curatorship
• Pregnancy (Positiveurinary/blood βHCG test)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de chirurgie digestive, hépato-bilio-pancréatique et transplantation hépatique. Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Claire GOUMARD, MD, PhD Assistant Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire GOUMARD, MD, PhD Assistant Professor

CONTACT

+33 6 07 77 39 06; claire.goumard@aphp.fr

Jean-Marc SIMON, Professor

CONTACT

+33 1 42 17 81 61; jean-marc.simon@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: January 23, 2024
• Study Start: May 31, 2024
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2030
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)