Hepatocellular Carcinoma | P2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma.
Hepatocellular Carcinoma research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Interferon Alfa、FluorouracilHepatic Arterial Infusion of 5-fluorouracil combined with systemic administration of Interferon-alpha Interferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks
Drug:Cisplatin、FluorouracilHepatic Arterial Infusion of 5-fluorouracil and Cisplatin (Low-dose FP) Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Interferon Alfa、FluorouracilInterferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks
Cisplatin、FluorouracilCisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks
Start Date: March 2013
Completed Date: February 2020
Phase: Phase 2
Primary Outcome: Two-year overall survival rate
Secondary Outcome: Progression free survival time
Study sponsors, principal investigator, and references
Principal Investigator: Hiroaki Nagano, MD, PhD
Lead Sponsor: Kansai Hepatobiliary Oncology Group