NCT00524498

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of a continuous hepatic arterial infusion combination therapy with OPC-18 and 5-FU versus BST in patients with highly advanced hepatocellular carcinoma for which resection therapy or local therapy is inapplicable due to advanced vascular invasion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

7 active sites

Status
completed

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

First Submitted

Initial submission to the registry

August 31, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

2.3 years

First QC Date

August 31, 2007

Last Update Submit

October 13, 2015

Conditions

Hepatocellular Carcinoma

Keywords

OPC-18Interferon-alphaFluorouracil

Outcome Measures

Primary Outcomes (1)

  • Antitumor effect (tumor size reduction)

    every 4 weeks

Secondary Outcomes (1)

  • Disease control rate Overall survival Progression-free survival

    every 4 weeks

Study Arms (2)

A

EXPERIMENTAL

FAIT

Drug: OPC-18

B

ACTIVE COMPARATOR

BST

Drug: cisplatin

Interventions

OPC-18DRUG

OPC-18: 500IU \* 3 times a week, sc 5-FU : 500mg infusion for 5days into hepatic artery

A
cisplatinDRUG

infusion into hepatic artery with cisplatin 10mg and 5-FU 250mg a day

Also known as: low-dose FP treatment
B

Eligibility Criteria

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

You may qualify if:

  • Patients who are histologically or clinically (diagnostic imaging and tumor marker) diagnosed with hepatocellular carcinoma
  • Patients with a measurable lesion by contrast CT
  • Patients with no remote metastasis (extrahepatic metastasis), confirmed by X-ray, CT, MRI, or other means if necessary
  • Patients who have not previously received intra-arterial hepatic chemotherapy

You may not qualify if:

  • Patients receiving the herbal medicine shosaikoto
  • Patients with autoimmune hepatitis
  • Patients with a history of hypersensitivity to OPC-18 or other interferon preparations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Katsuhisa Saito

    Divsion of New Product Development

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 31, 2007

First Posted

September 3, 2007

Study Start

September 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations

JP(7)