Adjuvant Hepatic Arterial Infusional Chemotherapy After Curative Resection of Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Several adjuvant therapies have been attempted to reduce uni-centric, and intra- or extrahepatic recurrence after curative surgical resection for hepatocellular carcinoma (HCC). However, because the efficacy of such adjuvant therapy remains unclear, there is no standard postoperative therapy.

The investigators investigated whether adjuvant hepatic arterial infusional chemotherapy with 5-fluorouracil (5-FU) and cisplatin reduces the recurrence of HCC after curative resection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Cisplatin; Fluorouracil

Criteria

Inclusion Criteria:

• age of 18 to 70 years old

• appropriate blood test results (white blood cells (WBCs) ≥3,000/mm3, platelet count ≥50,000/mm3, total bilirubin <3mg/dl)

• a patient could enter this study if one of the following was fulfilled

1. maximum diameter of HCC ≥5 cm,

2. microvascular or bile duct invasion upon pathological examination,

3. capsular invasion of HCC upon pathological examination, 4) Edmonson-Steiner grade III or IV.

Exclusion Criteria:

• patients with intra- or extrahepatic metastases at 4 weeks after resection

• Child-Pugh class B or C (n = 4)

• ECOG performance scale ≥2

• prior systemic chemotherapy, radiation, or locoregional therapy