Overview

P2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma.

Status:
Unknown status
Trial end date:
2020-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kansai Hepatobiliary Oncology Group
Treatments:
Cisplatin
Fluorouracil
Interferon-alpha
Interferons
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

-

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.

-