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CompletedNCT00524498Updated Oct 15, 2015

A Phase II Study of a Continuous Hepatic Arterial Infusion Combination Therapy With OPC-18 and 5-FU in Patients With Highly Advanced Hepatocellular Carcinoma

A Phase 2 interventional study of OPC-18 and cisplatin in Hepatocellular Carcinoma, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 7 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-10-15.

Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • OPC-18
  • Interferon-alpha
  • Fluorouracil
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 60 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients receiving the herbal medicine shosaikoto
  • Patients with autoimmune hepatitis
  • Patients with a history of hypersensitivity to OPC-18 or other interferon preparations
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    A

    FAIT

    Drug: OPC-18

  • Active comparator
    B

    BST

    Drug: cisplatin

Interventions

  • DrugOPC-18

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

  • Drugcisplatin

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

    Also known as: low-dose FP treatment

06

What researchers measure

Primary outcomes

  1. Antitumor effect (tumor size reduction)

    Time frame: every 4 weeks

Secondary outcomes

  1. Disease control rate Overall survival Progression-free survival

    Time frame: every 4 weeks

07

Study locations

7 sites
  • Chubu region, Japan
  • Chugoku region, Japan
  • Hokkaido region, Japan
  • Kanto region, Japan
  • Kinki region, Japan
  • Kyushu region, Japan
  • Tohoku region, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00524498
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 3, 2007
Start date
Sep 2007
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Oct 15, 2015

Study contacts

Katsuhisa Saito
study director · Divsion of New Product Development

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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