Randomised phase II study of postoperative hepatic arterial infusion chemotherapy (IFN/5-FU versus low-dose FP) for hepatocellular carcioma with portal vein tumor thrombus. (KHBO1207)

Randomised phase II study of postoperative hepatic arterial infusion chemotherapy (IFN/5-FU versus low-dose FP) for hepatocellular carcioma with portal vein tumor thrombus. (KHBO1207) - Random P2 study of postoperative IFN/5-FU vs LFP for HCC with PVTT. (KHBO1207)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010425

Enrollment

Registered

2013-04-05

Start date

2013-03-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

Hepatic Arterial Infusion of 5-fluorouracil combined with systemc administration of Interferon-alpha Hepatic Arterial Infusion of 5-fluorouracil and Cisplatin (Low-dose FP)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) hepatocelular carcinoma with histological or evidence or typical findings by CT or MRI. 2) surgically resetcable tumors with tumor thrombus in first branch or main trunk of portal vein. 3) 20 years old or more. 4) ECOG Performance status of 0 or 1. 5) Life expectancy of at least 6 months at the pre-treatment evaluation. 6) Child-Pugh class A or B. 7) Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements. WBC >= 2000/uL, Neutrophil >= 1000/uL, Hemoglobin >= 9.0 g/dL, Platelet count >= 75000/uL, Total Bilirubin <= 1.5mg/dl, AST/ALT <= 150 IU/L, Serum creatinine <= 1.2mg/dL, Creatinine clearance >= 60 ml/min

Exclusion criteria

Exclusion criteria: 1) Histological diagnosed combined hepatocellular and cholangiocellular carcinoma. 2) Extrahepatic tumor spread which affects patient's prognosis. 3) Hepatic encephalopathy 4) Active infections except for HBV and HCV. 5) Severee complications (IP, HF, RF, LF, ileus, DM, etc) 6) Active double cancer 7) Pregnancy 8-10) Medication or treatment that may affect to the absorption of drug or pharmacokinetics. 11) others, in the investigator's judgment.

Design outcomes

Primary

Measure	Time frame
2 years survival proportion	—

Countries

Japan

Contacts

Public ContactHiroshi Wada

Graduate School of Medicine, Osaka University Surgery

hwada98@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026