UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007303 |
|---|---|
| Receipt number | 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 13:18:14 |
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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 ≥ 18 years, an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, platelet count > 0.5  105/l, leukocyte count > 2000/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
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
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008611
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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