Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma

Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma

Indication : Hepatocellular carcinoma, maximum size 9 cm, with single or multiple nodes whose total tumor mass can technically be irradiated, non-resectable, and not a candidate for percutaneous therapy with recommended treatment via hyperselective transarterial chemoembolisation (TACE).

: Phase II controlled randomized trial, multicenter, comparing the benefit of additive conformational radiotherapy after therapy with hyperselective chemoembolisation (TACE) with treatment using three TACE treatments (standard of care).

Inclusion Criteria:

• Age ≥ 18 years of age
• ECOG 0-1
• life expectancy ≥ 6 months
• Histologically proven hepatocellular carcinoma or proven according to radiological and biochemical criteria (EASL-AASLD) in cirrhotic patients
• Maximum lesion size ≤ 9 cm
• Non-eligible for surgery or percutaneous therapy
• Premature Child-Pugh A or B (7 points for the Child-Pugh score)
• AST and ALT < 7 x UNL
• Technical possibility of conformational external radiotherapy
• Technical possibility of TACE
• All the tumor mass must be able to be treated by TACE
• Written consent signed by the patient
• Patients affiliated to a social security system

Exclusion Criteria:

• Metastatic illness
• Minimal lesion size ≤ 5 mm
• Non controlled viral replication B
• History of radiotherapy at abdominal level
• Subjects capable of procreating without efficient contraception
• pregnancy or nursing female patient
• Contraindication of TACE or external conformational radiotherapy
• Any other concomitant experimental treatment
• Contraindication of Doxorubicin
• Patients who are unable to respect enslaving respiratory constraints if used by sites
• Patients who are unable to understand information and to follow protocol instructions