UMIN-CTR Clinical Trial

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
Last 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
Email	contact@keio-hpbts.jp

Public contact
1st 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
Email	contact@keio-hpbts.jp

Sponsor
Institute	Keio University, School of medicine, Department of Surgery
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017574