Status:
UNKNOWN
P2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma.
Lead Sponsor:
Kansai Hepatobiliary Oncology Group
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 w...
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 a...
Eligibility Criteria
Inclusion
- hepatocellular carcinoma with histological or evidence or typical findings by CT or MRI.
- surgically resectable tumors with tumor thrombus in first branch or main trunk of portal vein.
- 20 years old or more.
- Eastern Cooperative Oncology Group Performance status of 0 or 1.
- Life expectancy of at least 6 months at the pre-treatment evaluation.
- Child-Pugh class A or B.
- 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
- Histological diagnosed combined hepatocellular and cholangiocellular carcinoma.
- Extrahepatic tumor spread which affects patient's prognosis.
- Hepatic encephalopathy
- Active infections except for hepatitis B virus(HBV) and hepatitis C virus(HCV).
- Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
- Active double cancer
- Pregnancy 8-10) Medication or treatment that may affect to the absorption of drug or pharmacokinetics.
- 11\) others, in the investigator's judgment.
- \-
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2020
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01834963
Start Date
March 1 2013
End Date
February 1 2020
Last Update
May 18 2018
Active Locations (1)
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1
Osaka University, Graduate School of Medicine
Osaka, Japan, 565-0871