Clinical trial NCT01834963: P2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Kansai Hepatobiliary Oncology Group
Sponsor class: NETWORK
First posted: 2013-04-18
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy, interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with hepatocellular carcinoma with portal vein tumor thrombus.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

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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 pharmacokinetics.

11) others, in the investigator's judgment.

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Primary outcomes:
measure: Two-year overall survival rate
timeFrame: Two years
Secondary outcomes:
measure: Progression free survival time
timeFrame: two years
measure: Overall survival time
timeFrame: two years
measure: toxicity
timeFrame: At the end of hepatic arterial infusion chemotherapy (6 months)
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka University, Graduate School of Medicine
Study officials:
affiliation: Osaka University Graduate School of Medicine
name: Hiroaki Nagano, MD, PhD
role: STUDY_DIRECTOR
References: