UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015739
Receipt number R000018315
Scientific Title The efficacy of HAIC in combination with sorafenib: multicenter, phase II study
Date of disclosure of the study information 2014/11/22
Last modified on 2020/04/12 09:18:25

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Basic information

Public title

The efficacy of HAIC in combination with sorafenib: multicenter, phase II study

Acronym

The efficacy of HAIC in combination with sorafenib.

Scientific Title

The efficacy of HAIC in combination with sorafenib: multicenter, phase II study

Scientific Title:Acronym

The efficacy of HAIC in combination with sorafenib.

Region

Japan


Condition

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Sorafenib is a useful molecular target drug for advanced hepatodellular carcinoma.However,the response rate is very low (0.6-3.3%). On the other hand, hepatic artery injection chemotherapy (HAIC) has higher response rate (8-71%) than sorafenib.In this study, we will evaluate the efficacy of HAIC in combination with sorafenib.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adverse effect, QOL, response rate, PFS, OS

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Sorafenib is administered orally 400 mg(2 x 200 mg) once or twice daily.The regimen of HAIC contains platinum,fluorouracil,epirubicin or mitomycin C. HAIC is repeated every 4 to 6 weeks.

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with advanced hepatocellular carcinoma who has already administerd sorafenib at least 4 weeks.

Key exclusion criteria

Patients with large volume ascites, brain metastases, hypertension (diastric pressure is over 100mmHg), uncontrorable cardiac problems, sever renal failure, active infection (without viral hepatitis), active gastric bleeding, cancer in other organ, hepatic encepharopathy, and sever drug allergy. Pregnant or lactating women, and the women who wish to be pregnant. Patients who have difficulty in oral feeding.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Takaaki
Middle name
Last name Sugihara

Organization

Tottori University Faculty of Medicine

Division name

Department of gastroenterology

Zip code

6838504

Address

36-1 Nishimachi, Yonago, Tottori prefecture

TEL

0859-38-6527

Email

sugitaka@med.tottori-u.ac.jp


Public contact

Name of contact person

1st name Takaaki
Middle name
Last name Sugihara

Organization

Tottori University Faculty of Medicine

Division name

Department of gastroenterology

Zip code

6838504

Address

36-1 Nishimachi, Yonago, Tottori prefecture

TEL

0859-38-6527

Homepage URL


Email

sugitaka@med.tottori-u.ac.jp


Sponsor or person

Institute

Tottori University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

No organization.

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

Advanced Medicine, Innovation and Clinical Research Center, Tottori University Hospital

Address

36-1 Nishimachi, Yonago, Tottori prefecture

Tel

0859386946

Email

crsc@ml.med.tottori-u.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

2014 Year 11 Month 22 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

Terminated

Date of protocol fixation

2014 Year 11 Month 21 Day

Date of IRB

2014 Year 11 Month 21 Day

Anticipated trial start date

2014 Year 11 Month 25 Day

Last follow-up date

2019 Year 01 Month 31 Day

Date of closure to data entry

2019 Year 01 Month 31 Day

Date trial data considered complete

2019 Year 01 Month 31 Day

Date analysis concluded

2019 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 11 Month 22 Day

Last modified on

2020 Year 04 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018315


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name