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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024396
Receipt No. R000028079
Scientific Title Prevention of recurrence after curative hepatectomy for hepatocellular carcinoma by Active Hexose Correlated Compound
Date of disclosure of the study information 2016/10/21
Last modified on 2020/04/16

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Basic information
Public title Prevention of recurrence after curative hepatectomy for hepatocellular carcinoma by Active Hexose Correlated Compound
Acronym Prevention of recurrence after curative hepatectomy for hepatocellular carcinoma by Active Hexose Correlated Compound
Scientific Title Prevention of recurrence after curative hepatectomy for hepatocellular carcinoma by Active Hexose Correlated Compound
Scientific Title:Acronym Prevention of recurrence after curative hepatectomy for hepatocellular carcinoma by Active Hexose Correlated Compound
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To prevention recurrence after curative hepatectomy for hepatocellular carcinoma by Active Hexose Correlated Compound

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relapse Free Survival
Key secondary outcomes Overall Survival
Patients Survival
serum albumin level

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
Food
Interventions/Control_1 Intake of Active Hexose Correlated Compound
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1)HCC diagnosed by CT and/or MRI within Stage A and B of BCLC clasification
2) without pre treatment for HCC
3) Stage A and AFPxPIVKA-II>=100000
4)without distant metastasis and macroscopic tumor thrombus
5)PS 0-2
6)Child-Pugh score <=7
function reserve of bone marrow, liver kidney
WBC>=2,000 /mm3 and <=10,000 /mm3
Plate>=50,000 /mm3 Hb>=8.0 g/dL
T.Bil<=2.0 mg/dL
PT%>=50%
Cr<=1.5 mg/dL
BUN<=35 mg/dL
7)accept of informed consent


Key exclusion criteria 1)without other cancer
2)severe cardiac and/or pulmonary failure
3)renal failure contraindication of enhanced CT and/or MRI
4)Mental illness
5)in pregnancy
6)already intake of AHCC
contraindication decided by doctor

Target sample size 50

Research contact person
Name of lead principal investigator
1st name Toshiya
Middle name
Last name Kamiyama
Organization Hokkaido University Graduate school of Medicine
Division name Gastroenterological Surgery I
Zip code 060-8638
Address N-15, W-7, Kita-ku, Sapporo Japan
TEL 011-706-5927
Email t-kamiya@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Hideki
Middle name
Last name Yokoo
Organization Hokkaido University Hospital
Division name Gastroenterological Surgery I
Zip code 060-8648
Address N-14, W-5, Kita-ku, Sapporo Japan
TEL 011-706-5927
Homepage URL
Email hi-yokoo@mua.biglobe.ne.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization AMINO UP Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido University Clinical Research Review Board
Address N-14, W-5, Kita-ku, Sapporo
Tel 011-706-7934
Email recjimu@huhp.hokudai.ac.jp

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
2016 Year 10 Month 21 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 31
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 No longer recruiting
Date of protocol fixation
2016 Year 10 Month 21 Day
Date of IRB
2016 Year 10 Month 21 Day
Anticipated trial start date
2016 Year 10 Month 21 Day
Last follow-up date
2021 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
2016 Year 10 Month 13 Day
Last modified on
2020 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028079

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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