Back to resultsA Phase II Study of a Continuous Hepatic Arterial Infusion Combination Therapy With OPC-18 and 5-FU in Patients With Highly Advanced Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
OPC-18
cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring OPC-18, Interferon-alpha, Fluorouracil
Eligibility Criteria
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:
- Patients receiving the herbal medicine shosaikoto
- Patients with autoimmune hepatitis
- Patients with a history of hypersensitivity to OPC-18 or other interferon preparations
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
FAIT
BST
Outcomes
Primary Outcome Measures
Antitumor effect (tumor size reduction)
Secondary Outcome Measures
Disease control rate Overall survival Progression-free survival
Full Information
NCT ID
NCT00524498
First Posted
August 31, 2007
Last Updated
October 13, 2015
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00524498
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
OPC-18, Interferon-alpha, Fluorouracil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
FAIT
Arm Title
B
Arm Type
Active Comparator
Arm Description
BST
Intervention Type
Drug
Intervention Name(s)
OPC-18
Intervention Description
OPC-18: 500IU * 3 times a week, sc 5-FU : 500mg infusion for 5days into hepatic artery
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
low-dose FP treatment
Intervention Description
infusion into hepatic artery with cisplatin 10mg and 5-FU 250mg a day
Primary Outcome Measure Information:
Title
Antitumor effect (tumor size reduction)
Time Frame
every 4 weeks
Secondary Outcome Measure Information:
Title
Disease control rate Overall survival Progression-free survival
Time Frame
every 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Patients receiving the herbal medicine shosaikoto
Patients with autoimmune hepatitis
Patients with a history of hypersensitivity to OPC-18 or other interferon preparations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsuhisa Saito
Organizational Affiliation
Divsion of New Product Development
Official's Role
Study Director
Facility Information:
City
Chubu region
Country
Japan
City
Chugoku region
Country
Japan
City
Hokkaido region
Country
Japan
City
Kanto region
Country
Japan
City
Kinki region
Country
Japan
City
Kyushu region
Country
Japan
City
Tohoku region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
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
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