UMIN-CTR Clinical Trial

Basic information
Public title	Pilot study of hepatic arterial infusion chemotherapy followed by sorafenib for advanced hepatocellular carcinoma
Acronym	HICS 55
Scientific Title	Pilot study of hepatic arterial infusion chemotherapy followed by sorafenib for advanced hepatocellular carcinoma
Scientific Title:Acronym	HICS 55
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 followed by sorafenib for advanced hepatocellular.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The 1-year survival rate
Key secondary outcomes	The 2-year survival rate Over all survival Respose rate of HAIC Survival rate according to HAIC response Time to progression of HAIC Response rate of sorafenib Survival rate according to sorafenib response Adverse events Liver function process

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 Maneuver
Interventions/Control_1	Hepatic arterial infusion chemotherapy (Low-Dose FP) Patients become refractory HAIC , followed by sorafenib.
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) 20 Years and older. 2) Life expectancy of at least 12 weeks at the pre-treatment evaluation. 3) Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or MRI. 4) Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization. 5) At least 4 weeks since last therapy for HCC. 6) Patients with no sorafenib and hepatic arterial infusion chemotherapy. 7) Intrahepatic tumor which affects patient'prognosis. 8) Extrahepatic tumor apread which not affects patient's prognosis. 9) ECOG Performance status of 0 or 1. 10) Child-Pugh 5,6,7 12) Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements: Granulocyte >= 3000/mm3 Platelet count >= 50,000 /mm3 Hemoglobin >= 8.5 g/dl Total serum bilirubin <= 3 mg/dl serum albimin>=2.8 Serum creatinine <= 1.5 mg/dl prothrombin consumption test>=50% Amylase <= 2 times upper limit of normal 12) Written Informed Consent must be obtained.
Key exclusion criteria	1) With other malignant disease. 2) A pregnant woman, or a woman suspected of pregnancy. 3) With severe infectious disease. 4) With history of severe allergy. 5) With severe renal function disease. 6) With severe allergy for 5FU or CDDP. 7) With severe bone marrow supression. 8) Esophageal and/or gastric varices which has high risk of bleeding and clinically significant gastro- intestinal bleeding. 9) Serious hypertension 10) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
Target sample size	55

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	082-257-5191
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 10 Month 11 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 10 Month 01 Day
Anticipated trial start date	2012 Year 10 Month 11 Day
Last follow-up date	2016 Year 12 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	2012 Year 10 Month 11 Day
Last modified on	2019 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010200