UMIN-CTR Clinical Trial

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	doi: 10.1177/15347354211073066.
Publication of results	Published

Result
URL related to results and publications	doi: 10.1177/15347354211073066.
Number of participants that the trial has enrolled	31
Results	A total of 29 patients were treated with AHCC. The 2-year recurrence-free survival rate after resection was 48% for those without discontinuations and 55.2% for all patients with a history of treatment. Serum albumin levels decreased to a minimum in the first postoperative month and gradually recovered to the preoperative level at 6 months. Almost no change in lymphocyte percentage was observed during follow-up. Inflammation-based prognostic scores were maintained at favorable levels after hepatectomy.
Results date posted	2022 Year 11 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 01 Month 25 Day
Baseline Characteristics	The study design was single-armed, non-randomized, open (no one was blinded), and uncontrolled. Patients with HCC who underwent curative hepatectomy were treated with AHCC (1 g) 3 times daily orally for 2 years. The inclusion criteria were HCC diagnosed preoperatively as stages A and B of the Barcelona clinic liver cancer (BCLC) classification and alpha-fetoprotein X protein induced by vitamin K absence or antagonist II (PIVKA-II) >= 100000 for stage A.
Participant flow	A total of 29 patients were treated with AHCC, of which 25 (4 patients discontinued) were followed up. The 2-year recurrence-free survival rate after resection was 48% for those without discontinuations and 55.2% for all patients with a history of treatment.
Adverse events	Toxicity and adverse events were not observed in any patient.
Outcome measures	Serum albumin levels decreased to a minimum in the first postoperative month and gradually recovered to the preoperative level at 6 months. Almost no change in lymphocyte percentage was observed during follow-up. Inflammation-based prognostic scores were maintained at favorable levels after hepatectomy.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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	2022 Year 11 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028079