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

Kansai Hepatobiliary Oncology Group

Status and phase: Unknown; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Cisplatin、Fluorouracil; Drug: Interferon Alfa、Fluorouracil

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01834963

KHBO1207

UMIN000010425 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Interferon Alfa、Fluorouracil

Experimental group

Description:

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

Treatment:

Drug: Interferon Alfa、Fluorouracil

Cisplatin、Fluorouracil

Experimental group

Description:

Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks

Treatment:

Drug: Cisplatin、Fluorouracil