UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005731 |
|---|---|
| Receipt number | R000006776 |
| Scientific Title | Hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma: Prospective randomized study |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2020/06/15 09:23:58 |
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Basic information
Public title
Hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma: Prospective randomized study
Acronym
HAIC for advanced HCC
Scientific Title
Hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma: Prospective randomized study
Scientific Title:Acronym
HAIC for advanced HCC
Region
| Japan |
Condition
Condition
Advanced hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investiated the efficacy of combination therapy with desferoxamine and sorafenib in advanced hepatocellular carcinoma patients who were non-responders for hepatic arterial infusion chemotherapy with anticancer drugs in prospective randomized study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival
Key secondary outcomes
Response, Progression-free survival, Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination therapy with desferoxamine and sorafenib
Interventions/Control_2
Sorafenib only
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) Patients with advanced hepatocellular carcinoma
2) Non-responders for chemotherapy with anticancer drugs and indication for sorafenib
3) Patients who have no influence on previous treatment
4) Performance status(PS) 0 or 1
5) Child-Pugh A
6) Favorable function of major organs (bone marrow, kidney, heart), and meeting citeria as follows:
(1) neutrophil count >= 1500/mm3
(2) platelet count>= 50000/mm3
(3) hemogrobin level >= 8.5g/dl
(4) serum creatinine level < 2mg/dl
(5) prothrombin time activity >= 50%
(6) age >= 20years, male and female
Key exclusion criteria
1) Severe coexisting illness (expect for chronic hepatitis or liver cirrhosis)
2) Active bouble cancers
3) serum creatinine level >= 2mg/dl
4) Past history of hypersensitivity for drugs including iodine and contrast agent
5) Patients with pregnancy, lactation or possibility of pregnancy
6) Patients who judged as inadequacy due to other reasons by the doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Yamasaki |
Organization
Yamaguchi University School of Medicine
Division name
First Department of Internal Medicine
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yamaguchi University School of Medicine
Division name
First Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
t.yama@yamaguchi-u.ac.jp
Sponsor or person
Institute
First Department of Internal Medicine, Yamaguchi University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2011 | Year | 09 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | 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
| 2011 | Year | 06 | Month | 07 | Day |
Last modified on
| 2020 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006776
| 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 |
