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Randomised Phase II Study of Postoperative Hepatic Arterial Infusion Chemotherapy (Interferon/Fluorouracil Versus Low-dose Cisplatin/Fluorouracil) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus.

Phase 2
20 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Randomised Phase II Study of Postoperative Hepatic Arterial Infusion Chemotherapy (Interferon/Fluorouracil Versus Low-dose Cisplatin/Fluorouracil) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus.

No standard treatment has been established for highly advanced hepatocellular carcinoma
(HCC) invading the major branches of the portal vein except for sorafenib. Some reports
suggested that hepatic arterial infusion chemotherapy improved survival of these patients.
Other reports indicated surgical intervention improved that survival. However, there is no
standard adjuvant therapy after liver resection for the patients with HCC with portal vein
tumor thrombus in the main or first branch of the portal vein. Our preliminary results
showed that combined interferon-alpha and intra-arterial 5-fluorouracil (5-FU) as a
postoperative therapy prolonged disease-free and overall survival after liver resection.
Hepatic arterial infusion chemotherapy using low-dose 5-FU and cisplatin is also promising
regimen for advanced HCC.

Herein, the investigators planed the study to evaluate efficacy (two year survival as
primary outcome, and overall-survival as secondary outcome) and safety ( as secondary
outcome) in hepatic arterial infusion chemotherapy with continuous infusion of
5-fluorouracil and systemic administration of interferon-alpha or low-dose 5-FU and
cisplatin, and to compare the efficacy as randomized control trial.

Inclusion Criteria:

1. hepatocellular carcinoma with histological or evidence or typical findings by CT or

2. surgically resectable tumors with tumor thrombus in first branch or main trunk of
portal vein.

3. 20 years old or more.

4. Eastern Cooperative Oncology Group 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.

white blood cell count >= 2000/microliter, Neutrophil >= 1000/microliter, Hemoglobin >=
9.0 g/dL, Platelet count >= 75000/microliter, Total Bilirubin <= 1.5mg/dl, aspartate
aminotransferase(AST) /alanine aminotransferase(ALT) <= 150 IU/L, Serum creatinine <=
1.2mg/dL, Creatinine clearance >= 60 ml/min


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 hepatitis B virus(HBV) and hepatitis C virus(HCV).

5. Sever complications (interstitial pneumonia, heart failure, renal failure, liver
failure, ileus, incontrollable diabetes mellitus, and so on)

6. Active double cancer

7. Pregnancy 8-10) Medication or treatment that may affect to the absorption of drug or

11) others, in the investigator's judgment.


Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Two-year overall survival rate

Outcome Description:

Duration: From randomization to evidenced death. Rate: Number of patients with evidenced death / number of total patients. 2 year survival rate: survival rate at two-year from the randomization

Outcome Time Frame:

Two years

Safety Issue:


Principal Investigator

Hiroaki Nagano, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Osaka University, Graduate School of Medicine


Japan: Institutional Review Board

Study ID:




Start Date:

March 2013

Completion Date:

February 2020

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Thrombosis
  • Carcinoma, Hepatocellular