NCT01834963

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

May 18, 2018

Status Verified

August 1, 2017

Enrollment Period

4.9 years

First QC Date

April 16, 2013

Last Update Submit

May 15, 2018

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Progression free survival time

    two years

  • Overall survival time

    two years

  • toxicity

    At the end of hepatic arterial infusion chemotherapy (6 months)

Study Arms (2)

Interferon Alfa、Fluorouracil

EXPERIMENTAL

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

Drug: Interferon Alfa、Fluorouracil

Cisplatin、Fluorouracil

EXPERIMENTAL

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

Drug: Cisplatin、Fluorouracil

Interventions

Interferon Alfa、FluorouracilDRUG

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

Also known as: Interferon Alfa ; IFN、, Fluorouracil ; 5-FU
Interferon Alfa、Fluorouracil
Cisplatin、FluorouracilDRUG

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

Also known as: Cisplatin ； Cispulan, Fluorouracil ; 5-FU
Cisplatin、Fluorouracil

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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.
  • \) others, in the investigator's judgment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka University, Graduate School of Medicine

Osaka, 565-0871, Japan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Interferon-alphaFluorouracilCF regimen

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hiroaki Nagano, MD, PhD

    Osaka University Graduate School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2013

First Posted

April 18, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2018

Study Completion

February 1, 2020

Last Updated

May 18, 2018

Record last verified: 2017-08

Locations

JP(1)