UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005818
Receipt number R000006874
Scientific Title An Investigation of the Safety of Continued Treatment with Sorafenib in Patients with Unresectable Hepatocellular Carcinoma after the First Disease Progression
Date of disclosure of the study information 2011/06/21
Last modified on 2018/11/07 09:20:40

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

An Investigation of the Safety of Continued Treatment with Sorafenib in Patients with Unresectable Hepatocellular Carcinoma after the First Disease Progression

Acronym

An Investigation of the Safety of Continued Treatment with Sorafenib in Patients with Unresectable Hepatocellular Carcinoma after the First Disease Progression

Scientific Title

An Investigation of the Safety of Continued Treatment with Sorafenib in Patients with Unresectable Hepatocellular Carcinoma after the First Disease Progression

Scientific Title:Acronym

An Investigation of the Safety of Continued Treatment with Sorafenib in Patients with Unresectable Hepatocellular Carcinoma after the First Disease Progression

Region

Japan


Condition

Condition

advanced hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to evaluate the safety and efficacy of continued treatment with sorafenib in patients with unresectable advanced HCC after documentation of PD according to the modified RECIST criteria.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety after documentation of the first PD

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Sorafenib 400mg twice daily

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histologically or clinically (imaging and tumor markers) diagnosed hepatocellular carcinoma
2)Not eligible for local treatment (e.g., surgery, RFA, TAE, and ethanol injection)
3)Lesions measurable with contrast-enhanced computed tomography (CT) or contrast- enhanced magnetic resonance imaging (MRI)
4)No carryover of effects or adverse effects of prior treatment (A washout period of at least 2 weeks will be established before the start of the clinical study for patients who have undergone hepatic resection, percutaneous local treatment, TAE, hepatic arterial infusion, and radiation therapy.)
5)Child-Pugh class A
6)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
7)Adequate functional reserve of major organs
8)Over 20 years old
9)Capable of complying with requirements with respect to visit days, medication, and laboratory tests
10)The patient provides written informed consent before the start of the clinical study

Key exclusion criteria

1)History of use of sorafenib or another molecular-targeted drug
2)History of systemic chemotherapy
3)Clinically significant ascites (i.e., refractory ascites requiring drainage)
4)History of liver transplantation
5)Esophageal varices with the potential to bleed
6)Any of the following diseases within 12 months before enrollment in the clinical study: myocardial infarction, unstable angina, cardiac failure, and cerebrovascular disorder
7)Concurrent or prior hepatic encephalopathy
8)Brain tumor
9)Currently on dialysis
10)Gastrointestinal hemorrhage during the previous month
11)Active double cancer
12)Currently treated with a CYP3A4 inducer (e.g., rifampicin)
13)Serious coexisting disease (NCI CTCAE grade 2 or higher arrhythmia and poorly controlled hypertension)
14)History of hypersensitivity to any component of the study drug
15)Orally taking an herbal medicine approved for the treatment of cancer (e.g., sho-saiko-to)
16)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) -related disease
17)Pregnant or nursing
18)Otherwise found by the investigator or subinvestigator to be ineligible as a subject

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuo Hamamoto

Organization

Keio university school of medicine

Division name

division of gastroenterology department of internal medicine

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Email

yhamamoto@z2.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriyuki Akutsu

Organization

Sapporo Medical University Hospital

Division name

First Department of Internal Medicine

Zip code


Address

Minami 1, Nishi 16-291, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Homepage URL


Email

akutsu@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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


Address


Tel


Email



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

2011 Year 06 Month 21 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2011 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 06 Month 13 Day

Last follow-up date

2014 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 06 Month 21 Day

Last modified on

2018 Year 11 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006874


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name