Prevention of recurrence after curative hepatectomy for hepatocellular carcinoma by Active Hexose Correlated Compound

JRCT ID: jRCTs011180006

Registered date:19/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 12/01/2017
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Intake of Active Hexose Correlated Compound
1 g, 3 times daily orally for 2 years

Outcome(s)

• Primary Outcome: Relapse Free Survival

Secondary Outcome

Overall survival
From the date of registration as the start date, the period until the date of death by any
Patients survival
From the date of registration as the starting date, the period until the date of death by hepatocellular carcinoma
serum albumin levels
Changes in serum albumin levels before and after treatment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kamiyama Toshiya
• Source(s) of Monetary Support: AMINO UP Co., Ltd.
• Secondary ID(s): UMIN000024396