UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013734 |
|---|---|
| Receipt number | R000016015 |
| Scientific Title | A phase I,II trial of hepatic arterial infusion chemotherapy with cisplatin and 5-fluorouracil for unresectable advanced hepatocellular carcinoma |
| Date of disclosure of the study information | 2014/04/16 |
| Last modified on | 2020/10/19 09:28:37 |
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Basic information
Public title
A phase I,II trial of hepatic arterial infusion chemotherapy with cisplatin and 5-fluorouracil for unresectable advanced hepatocellular carcinoma
Acronym
A phase I,II trial of HAIC with CDDP+5-FU for advanced HCC
Scientific Title
A phase I,II trial of hepatic arterial infusion chemotherapy with cisplatin and 5-fluorouracil for unresectable advanced hepatocellular carcinoma
Scientific Title:Acronym
A phase I,II trial of HAIC with CDDP+5-FU for advanced HCC
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety, efficacy
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
safety
Key secondary outcomes
efficacy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
hepatic arterial infusion chemotherapy. 5-FU 300mg/m2, day 1 to 5, 5 to 19. CDDP 45mg/m2, 55mg/m2 or 65mg/m2, day2. 1 course = 28 days. continue till PD.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients were considered eligible for this study based on following criteria: advanced unresectable hepatocellular carcinoma; clinical stage III or IVA; no prior chemotherapy or radiation therapy within one month; an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; age; 18 years; adequate baseline bone marrow function (hemoglobin level>9g/dl, neutrophil count>1,500/mm3 and platelet count >70,000/mm3) ; adequate hepatic function (total bilirubin level;2.0 mg/dl, aspartate aminotransferase and alanine aminotransferase levels five times the upper limit of normal); adequate renal function (serum creatinine level1.5 mg/dl); adequate respiratory and cardiac function; no metastatic lesion except for liver; and life expectancy at least three months. Written informed consent was obtained from all patients.
Key exclusion criteria
complete obstruction of either celiac artery, common hepatic artery or splenic artery
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Miyanishi |
Organization
Sapporo Medical University School of Medicine
Division name
Dept. of Medical Oncology
Zip code
Address
South1, West16, Chuo-ku, Sapporo
TEL
011-611-2111
miyako@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Miyanishi |
Organization
Sapporo Medical University School of Medicine
Division name
Dept. of Oncology and hematology
Zip code
Address
South1, West16, Chuo-ku, Sapporo
TEL
0119611-2111
Homepage URL
miyako@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 04 | Month | 16 | 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
Completed
Date of protocol fixation
| 2008 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2008 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2008 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 16 | Day |
Last modified on
| 2020 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016015
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
