Phase III Randomized Study of Surgical Resection With Versus Without Postoperative Hepatic Arterial Chemotherapy in Patients With Hepatocellular Carcinoma and Portal Vein Tumor Thrombus
- Compare the efficacy of surgical resection with vs without postoperative hepatic
arterial chemotherapy in patients with hepatocellular carcinoma and portal vein tumor
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to grade
of portal invasion and Child-Pugh classification. Patients are randomized to 1 of 2
- Arm I: Patients undergo macroscopic curative resection. Within 28 days after surgery,
patients without post-surgery complications undergo hepatic arterial infusion
comprising fluorouracil and cisplatin on days 1-5, 8-12, and 15-19. Treatment continues
for 6 months.
- Arm II: Patients undergo macroscopic curative resection.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
Primary Purpose: Treatment
Iwao Ikai, MD
United States: Federal Government