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

Hepatocellular Carcinoma Clinical Trial

Official title:

Randomised Phase II Study of Postoperative Hepatic Arterial Infusion Chemotherapy (Interferon/Fluorouracil Versus Low-dose Cisplatin/Fluorouracil) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01834963
• Other study ID #: KHBO1207
• Secondary ID: UMIN000010425
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2013
• Est. completion date: February 2020

Study information

• Verified date: August 2017
• Source: Kansai Hepatobiliary Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: February 2020
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Japan	Osaka University, Graduate School of Medicine	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Kansai Hepatobiliary Oncology Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-year overall survival rate	Duration: From randomization to evidenced death.; Rate: Number of patients with evidenced death / number of total patients.; 2 year survival rate: survival rate at two-year from the randomization	Two years
Secondary	Progression free survival time	Progression free survival time from randomization to tumor progression based on RECIST or recurrence after curative surgery was calculated by Kaplan Meier methods.	two years
Secondary	Overall survival time	Overall survival time from randomization to evidence death was calculated by Kaplan Meier methods.	two years
Secondary	toxicity	The incidence of adverse events evaluated by CTCAE Ver4.0.	At the end of hepatic arterial infusion chemotherapy (6 months)