UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007303
Receipt No. R000008611
Scientific Title The efficacy of hepatic arterial infusion chemotherapy using 5-fluorouracil and systemic pegylated interferon alpha-2b for advanced intrahepatic cholangiocarcinoma
Date of disclosure of the study information 2012/02/25
Last modified on 2012/11/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The efficacy of hepatic arterial infusion chemotherapy using 5-fluorouracil and systemic pegylated interferon alpha-2b for advanced intrahepatic cholangiocarcinoma
Acronym Combined 5-FU and PEG-IFN alpha-2b therapy for ICC
Scientific Title The efficacy of hepatic arterial infusion chemotherapy using 5-fluorouracil and systemic pegylated interferon alpha-2b for advanced intrahepatic cholangiocarcinoma
Scientific Title:Acronym Combined 5-FU and PEG-IFN alpha-2b therapy for ICC
Region
Japan

Condition
Condition advanced intrahepatic cholangiocarcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The efficacy of hepatic arterial infusion chemotherapy (HAIC) using 5-fluorouracil (5-FU) combined with subcutaneous administration of pegylated interferon (PEG-IFN) alpha-2b in patients with advanced ICC was evaluated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint of interest was the overall response rate
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria The patients were required to have histologically confirmed, unresectable, and measurable ICC. Other eligibility criteria were age &#8805; 18 years, an Eastern Cooperative Oncology Group (ECOG) performance status of 0&#8211;2, platelet count > 0.5 &#61620; 105/&#61549;l, leukocyte count > 2000/&#61549;l, total bilirubin < 3 mg/dl, serum creatinine < 1.5 mg/dl, and successful implantation of an intra-arterial catheter and drug delivery system.
Key exclusion criteria Pregnancy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Kasai
Organization Iwate Medical University
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address Uchimaru 19-1, Morioka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Iwate Medical University
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization Iwate Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2008 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The objective early response rate was 66.7%. Cumulative survival rates were 69.3% at 12 months and 34.6% at 24 months. The median survival time was 18.5 months. All adverse reactions were controllable by temporary suspension of treatment. Serious complications and treatment-related deaths were not observed.

Management information
Registered date
2012 Year 02 Month 15 Day
Last modified on
2012 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008611

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.