UMIN-CTR Clinical Trial

Public title

Efficacy of entecavir as an adjuvant therapy for hepatocellular carcinoma
derived from HBV infection:
a prospective trial

Acronym

ETV-HCC

Scientific Title

Efficacy of entecavir as an adjuvant therapy for hepatocellular carcinoma
derived from HBV infection:
a prospective trial

Scientific Title:Acronym

ETV-HCC

Region

Japan

Condition

HBV related CHB/LC/HCC

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We examine it in a prospective study whether nucleoside analog administration can be provided safely and decrease a recurrence after the curative resection of hepatocellular carcinoma with the chronic hepatitis B and cirrhosis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Recurrence free survival

Key secondary outcomes

effective evaluation
(1) Overall survival
(2) HBV-DNA at1m,3m,6m,9m,12m
(3) Liver function
(4) Child Pugh Score
Safety assessment
(1) Adverse event frequencies
(2) Liver function 6m,12m later after registration
(3) Liver residual function(ICGR-15)
(4) Child-Pugh score
(5) Background liver histology at the re-resection

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Entecavir 0.5mg/day

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Age at the time of the agreement acquisition 20 years old or older
2) No macroscopic vascular invasion, No extra hepatic lesion, be resected a hepatocellular carcinoma for a radical cure purpose. (no clear persistence. There is more than 2 years after treatment in the case of a
3) HBs antigen is positive, and given a diagnosis of hepatitis B, cirrhosis of the liver at the time of screening clinically (before resection).
4)WBC more than 2,000/mm3, Hb more than 7.5g/dL, Platelet more than 50,000 / mm3 .
5)The patients with liver disease to meet all the following conditions:-The extension that is with three seconds of the normal value or less of prothrombin time, or INR is 1.5 or less.
-Albumin is more than 2.5g/dL.
-Total bilirubin is less than2.5g/dL.
6)There were not the severe complications just after the operation, and attending staff judged to be able to leave the hospital recurrence

Key exclusion criteria

(1)the pregnancy and the nursing.
(2)Women with childbearing age who is impossible to undergo appropriate contraception.
(3) The women who are positive by an examination of pregnancy with less than 72 hours before administration start or at screening.
(4)The patients with bleeding varicose vein, the hepatic encephalopathy now, and need treatment.
(5) The patients with other liver diseases by an anamnesis, liver biopsy or a laboratory study.
(6) CP score 13 or more in the patients with cirrhosis.
(7) Absolute non-curative resection case.
(8) Recurrent case within 24 months after the HCC radical operation.
(9) HIV infection
(10)Pancreatitis within 24 weeks before study drug administration start.
(11)The patients who were judged when alcoholism did not enable appropriate medication or raised the risk of hepatotoxicity and the pancreatitis.
(12)The patients with difficulty in conducting a clinical trial by other serious conditions.
(13)Serum creatinine levels exceed the twice the normal value upper limit, or
eGFR<30mL/min or less.
(14) Hemoglobin < 7.5 g/dL.
(15) Platelet count < 50,000/mm3.
(16) A granulocyte count < 1,500/ mm3.
(17) The patients with allergic history by the nucleoside analog.
(18)The patients who received immunosuppressive therapy within four weeks before therapeutic drug administration start.
(19)The patients who received the IFN within 12 weeks before study.
(20) The patients using ETV before.
(21) The patients received the hepatitis B therapeutic drug (lamivudine) of the nucleoside analog.
(22) The case that we continued surgery until just before that more than three months, and was given nucleic acid analog.
(23) The patients who cannot be given it orally.
(24) The patients who have difficulty in puncture of peripheral vessels.
(25) The patients who are restricted forcibly by a legal reason or a mental disease, a physical disease (including the infection).
(26) In addition, the patients that attending staff of this study judged that administration was inappropriate.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Norihiro Kokudo

Organization

Tokyo University Hospital

Division name

Hepato-Biliary-Pancreatic Surgery Division

Zip code

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

+81-3-3520-0111

Email

sukeyaubj@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Yosuke Inoue

Organization

Tokyo University Hospital

Division name

Hepato-Biliary-Pancreatic Surgery Division

Zip code

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

+81-3-3520-0111

Homepage URL

Email

sukeyaubj@yahoo.co.jp

Institute

Tokyo University Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

07

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

05

Month

10

Day

Date of IRB

Anticipated trial start date

2011

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

07

Month

18

Day

Last modified on

2019

Year

01

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007090