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
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
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
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
