UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009272
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last 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
Email chayama@hiroshima-u.ac.jp

Public contact
1st 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
Email aikata@hiroshima-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Metabolism,Hiroshima University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010511

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.