UMIN-CTR Clinical Trial

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