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Hepatocellular carcinoma (HCC) with portal venous invasion (PVI) has a very poor prognosis, with a median survival of 3 months and virtually no survival at 1 year. The combination of intraarterial 5-fluorouracil (FU) and systemic peg-interferon (peg-IFN) was recently reported to be effective against HCC with PVI, but these were small pilot studies.Six hundred and forty-nine patients with HCC with PVI received peg-IFN (90 µg subcutaneously on days 1 of each week of treatment) and 5-FU (500 mg into hepatic artery on days 1–5 of the first and second week of each 4-week cycle). The therapy was either terminated at the end of the first cycle in cases with progressive disease, or continued for at least three cycles, when responses to treatment were evaluated by Eastern Cooperative Oncology Group criteria.Seventy-one (10%) patients showed complete response and another 154 (24%) showed partial response. Adverse events were limited to nausea and appetite loss. The survival rates at 12 and 24 months among overall patients were 33% and 14%, respectively. MST was 6.9 months. Survival rates at 12 and 24 months were 91% and 61% among complete responders, respectively, and 52% and 16% among partial responders.The combination therapy with 5-FU and IFN was safe, and substantially improved the survival rate among the complete responders. Sorafenib was recently reported to be first choice against advanced HCC. Now we conduct RCT.