UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015101 |
|---|---|
| Receipt number | R000017574 |
| Scientific Title | A phase 1 trial of hepatic arterial infusion chemotherapy with high dose cisplatin and 5-fluorouracil for unresectable advanced and recurrent hepatocellular carcinoma |
| Date of disclosure of the study information | 2014/09/10 |
| Last modified on | 2019/03/15 12:05:25 |
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Basic information
Public title
A phase 1 trial of hepatic arterial infusion chemotherapy with high dose cisplatin and 5-fluorouracil for unresectable advanced and recurrent hepatocellular carcinoma
Acronym
A phase 1 trial of HAIC with high dose CDDP + 5-FU for advanced HCC
Scientific Title
A phase 1 trial of hepatic arterial infusion chemotherapy with high dose cisplatin and 5-fluorouracil for unresectable advanced and recurrent hepatocellular carcinoma
Scientific Title:Acronym
A phase 1 trial of HAIC with high dose CDDP + 5-FU for advanced HCC
Region
| Japan |
Condition
Condition
hepatocelllar carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Incidence of dose limiting toxicity
Key secondary outcomes
Adverse effect, response rate, progression free survival, safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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 with high dose CDDP and 5-FU
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histology/cytology-or clinically (by imaging or tumor marker) proven advanced hepatocellular carcinoma
2) ECOG PS of 0 or1
4) Child-Pugh A or B
5) The function of the major organ is kept as satisfied by the following requirement, a) Neutrophil >= 1,500/microL, b) Platelets >=50,000/microL, c) Hemoglobin >= 8.5g/dL
d) PT% >=40%, e) AST or ALT <= 5 *Upper limit of Normal(ULN), f) Cr <= 1.5 *ULN
6) written informed consent
Key exclusion criteria
(1) Active second primary malignancies.
(2) Within 3 years after radical treatment of another cancer
(3) With extrahepatic metastasis.
(4) Patients with ascites possessed clinical meaning.
(5) Hepatic Encephalopathy
(6) Critical renal failure or hemodialysis
(7) Contraindication of CDDP and 5-FU
(8) Any patients are pregnant/ nursing
(9) After administration of TS-1
(10) Auditory disorder
(11) Patients with serious infection
(12) Gastrointestinal ulcer or bleeding
(13) Uncontrolled DM
(14) Those judged to be not suitable by the attending physician
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Itano |
Organization
Keio University, School of medicine
Division name
Department of Surgery
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
contact@keio-hpbts.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Itano |
Organization
Keio University, School of medicine
Division name
Department of Surgery
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
contact@keio-hpbts.jp
Sponsor or person
Institute
Keio University, School of medicine, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Keio University, School of medicine, Department of Surgery
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
| 2014 | Year | 09 | Month | 10 | 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
| 2013 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | 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 | 09 | Month | 10 | Day |
Last modified on
| 2019 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017574
