Randomized Phase II Study of 5-fluorouracil Hepatic Arterial Infusion With or Without Antineoplastons as an Adjuvant Therapy After Hepatectomy for Liver Metastases from Colorectal Cancer

Interventions: In both the AN arm and the control arm, patients received HAI with 5-FU at a dose of 1000 mg/m2 for 4 hours weekly or biweekly until the cumulative dose reached up to 15,000 mg.
In the AN arm, a starting dose of 30 g/day of A10-I was administered intravenously (i.v.) using a pump system with maximum dose of 100 g/day for more than 3 days. After completion of the i.v. administration of A10-I for a week, 10 g/day of AS2-1 was administered orally for 1 year. Patients in the control group receive no antineoplastons.
Primary outcome(s): The primary objective was to determine whether systemic administration of antineoplastons added to adjuvant 5-FU HAI after liver resection increased cause-specific survival (CSS).
Study Design: Parallel Randomized