UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006475
Receipt number R000007686
Scientific Title Evaluation of the safety and efficacy of sorafenib therapy after TACE for unresectable hepatocellular carcinoma (multicenter study)
Date of disclosure of the study information 2011/10/05
Last modified on 2012/10/29 19:45:42

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Basic information

Public title

Evaluation of the safety and efficacy of sorafenib therapy after TACE for unresectable hepatocellular carcinoma (multicenter study)

Acronym

Investigation for safety and efficacy of Sorafenib TreatmEnt Post-TACE in HCC: i-STEP

Scientific Title

Evaluation of the safety and efficacy of sorafenib therapy after TACE for unresectable hepatocellular carcinoma (multicenter study)

Scientific Title:Acronym

Investigation for safety and efficacy of Sorafenib TreatmEnt Post-TACE in HCC: i-STEP

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of sorafenib after transcatheter arterial chemoembolization (TACE) for unresectable hepatocellular carcinoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time to progression

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

To evaluate the safety and efficacy of sorafenib therapy after TACE in patients with unresectable hepatocellular carcinoma who have PD within 6 months after prior TACE as assessed according to the modified RECIST criteria and thus are anticipated to have a reduced response to any subsequent TACE.

Interventions/Control_2

Patients are not given sorafenib after prior TACE (the control group).

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) Male or female aged 20 years or older at the time of enrollment
2) Patients who have provided written consent to participate in this study
3) Patients with histologically or clinically (based on diagnostic imaging and tumor markers) diagnosed hepatocellular carcinoma
4) Patients not indicated for hepatectomy, liver transplant, or percutaneous local treatment (i.e., radiofrequency ablation, ethanol injection)
5) Patients assessed as having progressive disease (PD) according to the modified RECIST criteria within 6 months following prior TACE
6) Patients who had a measurable lesion as specified by the modified RECIST criteria on computed tomographic arteriography (CTA) or computed tomographic arterial portography (CTAP) obtained immediately before the index TACE
7) Patients who completed TACE appropriately
8) Patients without any residual adverse effects of TACE
9) Patients in Child-Pugh Class A
10) Patients with an ECOG Performance Status (PS) score of 0 or 1
11) Patients with adequate functions of major organs

Key exclusion criteria

1) Patients previously treated with sorafenib or other molecular-targeting therapy
2) Patients previously treated with systemic chemotherapy
3) Patients with clinically significant ascites (refractory ascites requiring paracentesis)
4) Patients with extra-hepatic metastases at the time of the index TACE (Chest CT must be performed for confirmation.)
5) Patients with vascular invasion of Vp3/4 and Vv2/3 at the time of the index TACE
6) Patients with diffuse lesions at the time of the index TACE
7) Patients with a history of liver transplant
8) Patients with potential bleeding from esophageal varices
9) Patients who experienced any of the following within 12 months prior to enrollment in this study
10) Patients with a current or past history of hepatic encephalopathy
11) Patients with a brain tumor
12) Patients undergoing dialysis
13) Patients who had gastrointestinal hemorrhage within the past month
14) Patients with multiple active cancers
15) Patients receiving CYP3A4 inducers (e.g., rifampicin)
16) Patients with serious comorbidities (NCI-CTCAE Ver. 4 Grade 2 or greater arrhythmia, uncontrolled hypertension)
17) Patients with a history of serious hypersensitivity to sorafenib
18) Patients taking oral herbal medicine approved for the treatment of cancer (e.g., Shosaikoto)
19) Patients with disorders related to human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)
20) Pregnant or breastfeeding patients
21) Other patients judged by the principal investigator or a co-investigator to be inappropriate to participate in this stud

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirohito Tsubouti

Organization

Kagoshima University Medical and Dental Hospital

Division name

Department of Gastroenterology

Zip code


Address

8-35-1, Sakuragaoka, Kagoshima, Kagoshima

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Tsutomu Tamai

Organization

Kagoshima University Medical and Dental Hospital

Division name

Department of Gastroenterology

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Kagoshima University Medical and Dental Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

鹿児島大学医学部・歯学部付属病院(鹿児島県)、鹿児島厚生連病院(鹿児島県)、鹿児島逓信病院(鹿児島県)、霧島市立医師会医療センター(鹿児島県)、済生会川内病院(鹿児島県)、南風病院(鹿児島県)、藤元早鈴病院(鹿児島県)、宮崎医療センター病院(鹿児島県)


Other administrative information

Date of disclosure of the study information

2011 Year 10 Month 05 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

Enrolling by invitation

Date of protocol fixation

2011 Year 08 Month 15 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 10 Month 04 Day

Last modified on

2012 Year 10 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007686


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name