Non-metastatic Hepatocellular Carcinoma
Conditions
Keywords
Liver neoplasms, Carcinoma, Hepatocellular, Radiation therapy, TACE, Transarterial Chemoembolization
Brief summary
Patients with non-metastatic unresectable hepatocellular carcinoma
Interventions
One cure of doxorubicin or DC Beads transarterial chemoembolization by a highly experienced interventional radiologist, followed 1 to 4 weeks later by hypofractionated external beam radiation therapy up to a total dose of 45-60 Gy, 3 Gy per fraction, 5 fractions per week, for an overall treatment time of 3 to 4 weeks.
Surgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma by a highly experienced liver surgeon
Sponsors
Study design
Eligibility
Inclusion criteria
* Age ≥18 years of age * ECOG 0-2 * Histologically proven hepatocellular carcinoma or proven according to radiological and biochemical criteria (EASL-AASLD) in cirrhotic patients * Child-Pugh class A * Absence of truncular or lobar portal vein invasion, or suprahepatic vein invasion
Exclusion criteria
* Uncontrolled replication of hepatitis B virus * Transplanted liver * Previous abdominal irradiation * Previous treatment of HCC with systemic therapy, or with surgical resection in the 2 previous years * Metastatic illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival of the patient after start of treatment | Within 10 years after the treatment (surgical resection or TACE) | Disease-Free Survival (DFS) defined as the time (in months) between the treatment (surgical resection or TACE) and the diagnostic of local, locoregional or distant recurrence, or date of death from any cause; patients who are alive or lost to follow-up at the time of the analysis will be censored on the last follow-up date; patients who have received a liver transplant for non-carcinologic reason will be censored on the date of transplantation. |
Countries
France