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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006475
Receipt No. 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

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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
Institute Kagoshima University Medical and Dental Hospital
Institute
Department

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
URL(English) https://upload.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


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