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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009094
Receipt No. R000010200
Scientific Title Pilot study of hepatic arterial infusion chemotherapy followed by sorafenib for advanced hepatocellular carcinoma
Date of disclosure of the study information 2012/10/11
Last modified on 2019/04/12

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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