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

Condition(s) studied

Investigational drug(s) / intervention(s)

Stereotactic Body Radiotherapy (SBRT): 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.

Study 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.

Eligibility

Primary outcome measure(s)

• To evaluate the efficacy of stereotactic body radiotherapy (SBRT) as bridging therapy for patients with hepatocellular carcinoma (HCC) enlisted for liver transplantation (LT). — Within 15 months following SBRT.
  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.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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