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.
20 Years
N/A
Both
Hepatocellular Carcinoma
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
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
-
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.
-
Type of Study:
Interventional
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:
Yes
Principal Investigator
Hiroaki Nagano, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Osaka University, Graduate School of Medicine
Authority:
Japan: Institutional Review Board
Study ID:
KHBO1207
NCT ID:
NCT01834963
Start Date:
March 2013
Completion Date:
February 2020
Related Keywords:
- Hepatocellular Carcinoma
- Carcinoma
- Thrombosis
- Carcinoma, Hepatocellular
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