A Double-Blind, Randomized, Phase II/III Study Comparing the Use of Chemoembolization Combined With Sunitinib Against Chemoembolization Combined With a Placebo in Patients With Hepatocellular Carcinoma (SATURNE)
- To evaluate unacceptable bleeding or hepatic failure at 10 weeks post-treatment in
patients with unresectable hepatocellular carcinoma treated with transarterial
chemoembolization in combination with sunitinib malate versus transarterial
- To evaluate the overall survival of these patients.
- To evaluate the tumor stabilization rate in these patients.
- To evaluate the safety of this regimen in these patients.
- To evaluate the disease-free survival of these patients.
- To evaluate the relapse-free survival of these patients.
- To evaluate the quality of life of these patients.
- To evaluate the overall survival rate at 2 years of these patients.
OUTLINE: This is a multicenter study.
Pilot: Patients receive oral sunitinib malate once daily on days 1-28. Beginning 7-10 days
later, patients undergo 1-3 courses of transarterial chemoembolization (TACE). Treatment
repeats every 6 weeks for 1 year.
Randomization: Patients are stratified according to main tumor diameter (< 5 cm vs ≥ 5 cm),
nodular involvement (uninodular vs multinodular), and center. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive sunitinib malate and TACE as in the pilot phase.
- Arm II: Patients receive oral placebo once daily on days 1-28 and TACE as in the pilot
Quality of life is assessed periodically.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Unacceptable bleeding or hepatic failure at 10 weeks post-treatment
Mohamed Hebbar, MD
Centre Hospital Universitaire Hop Huriez