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

NCT ID: NCT01834963

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2020-02-29

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 with portal vein tumor thrombus.

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 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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interferon Alfa、Fluorouracil

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

Group Type: EXPERIMENTAL

Interferon Alfa、Fluorouracil

Intervention Type: DRUG

Hepatic 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

Cisplatin、Fluorouracil

Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks

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

Group Type: EXPERIMENTAL

Cisplatin、Fluorouracil

Intervention Type: DRUG

Hepatic 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

Interventions

Interferon Alfa、Fluorouracil

Hepatic 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

Intervention Type: DRUG

Cisplatin、Fluorouracil

Hepatic 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

Intervention Type: DRUG

Other Intervention Names

Interferon Alfa ; IFN、; Fluorouracil ; 5-FU; Cisplatin ； Cispulan; Fluorouracil ; 5-FU

Eligibility 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

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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.

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• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kansai Hepatobiliary Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiroaki Nagano, MD, PhD

Role: STUDY_DIRECTOR

Osaka University Graduate School of Medicine

Locations

Osaka University, Graduate School of Medicine

Osaka, , Japan

Site Status: RECRUITING

Countries

Japan

Facility Contacts

Hiroshi Wada

Role: primary

+81-6-6879-3251

Other Identifiers

UMIN000010425

Identifier Type: REGISTRY

Identifier Source: secondary_id

KHBO1207

Identifier Type: -

Identifier Source: org_study_id