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
NCT ID: NCT00524498
Last Updated: 2015-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2007-09-30
2010-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
P2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma.
NCT01834963
Hepatic Arterial Infusion of Oxaliplatin and Fluorouracil Treatment of Advanced Primary Liver Cancer After TACE
NCT02557503
Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
NCT01406574
Study of Sorafenib In Combination With Low-dose 5-fluorouracil/Cisplatin (FP) Intraarterial Infusion Chemotherapy
NCT00933816
Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma
NCT00241020
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
FAIT
OPC-18
OPC-18: 500IU \* 3 times a week, sc 5-FU : 500mg infusion for 5days into hepatic artery
B
BST
cisplatin
infusion into hepatic artery with cisplatin 10mg and 5-FU 250mg a day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OPC-18
OPC-18: 500IU \* 3 times a week, sc 5-FU : 500mg infusion for 5days into hepatic artery
cisplatin
infusion into hepatic artery with cisplatin 10mg and 5-FU 250mg a day
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 with autoimmune hepatitis
* Patients with a history of hypersensitivity to OPC-18 or other interferon preparations
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Katsuhisa Saito
Role: STUDY_DIRECTOR
Divsion of New Product Development
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chubu Region, , Japan
Chugoku Region, , Japan
Hokkaido Region, , Japan
Kanto Region, , Japan
Kinki Region, , Japan
Kyushu Region, , Japan
Tohoku Region, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
018-06-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.