UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009272 |
|---|---|
| Receipt number | R000010511 |
| Scientific Title | pilot study of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma patients in Child-Pugh score 8,9 |
| Date of disclosure of the study information | 2012/11/06 |
| Last modified on | 2019/04/15 21:12:48 |
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Basic information
Public title
pilot study of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma patients in Child-Pugh score 8,9
Acronym
Efficacy of TAI with cisplatin for HCC in Child-Pugh score8,9
Scientific Title
pilot study of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma patients in Child-Pugh score 8,9
Scientific Title:Acronym
Efficacy of TAI with cisplatin for HCC in Child-Pugh score8,9
Region
| Japan |
Condition
Condition
advanced hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy of hepatic arterial infusion chemotherapy with cisplatin for unresectable advanced hepatocellular carcinoma, and to evaluate safety and tumor response with this therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
1) overall survival
2) time to progression
3) safety
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 with cisplatin
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with hepatocellular carcinoma diagnosed by histologial examination or by imaging modalities
2) no adaptation or no response of resection, liver transplantation and local abration,TACE,HAIC
3) Male or female aged 20 years or older at the time of informed consent and younger than 90 years old
4) Convalescence decided by hepatic leision
5) At least 1 target lesion measurable by RECIST/Modified RECIST
6) Interval of 4 weeks or over between last treatment and present therapy
7) Patients with an ECOG Performance Status (PS) score of 0 or 1,2
8) Patients in Child-Pugh score 8or 9
9) Adequate organ function
a) Neutrophil>=1500 /mm3
b)PLT>= 50000 /mm3
c) Hb>= 8.0g/dL
d) T-Bil<= 5.0 mg/dL
e) AST<= within 5 times of normal limit
ALT<= within 5 times of normal limit
f) Cre<= within 1.5 times of normal limit
g) PT>=40%
h) No need of treatment on ECG
10) Life expectancy of at least 3 months
11) Patients obtained written informed consent
Key exclusion criteria
1) Severe arterio-portal or arterio-venous shunts in the liver
2) Patinets with difficulty with drug arrival to hepatic lesion
3) Other uncontrolled severe illness.
a) With severe cardiac failure
b) With severe renal function disease
c) With active infectious disease except viral hepatitis.
d) With active gastrointestinal hemorrhage
e) With active other malignancies.
f) With hepatic encephalopathy and severe mental disorder
g) With clinically significant refractory ascites or pleural effusion
4) Allergic reaction to iodine contrast material, gadolinium contrast material, or platium containing agent.
5) A pregnant woman, or a woman suspected of pregnancy.
6) Patients who are concluded to be inappropriate to participate in this study by their physitians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Chayama |
Organization
Hiroshima University Hospital
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5555
chayama@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Aikata |
Organization
Hiroshima University Hospital
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5191
Homepage URL
aikata@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Metabolism,Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Metabolism,Hiroshima University Hospital
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
| 2012 | Year | 11 | Month | 06 | 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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 06 | Day |
Last modified on
| 2019 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010511
