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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004316
Receipt No. R000005114
Scientific Title Phase II study: Transcatheter Arterial Chemoembolization Therapy In Combination with Sorafenib (TACTICS)
Date of disclosure of the study information 2010/10/04
Last modified on 2010/10/03

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Basic information
Public title Phase II study: Transcatheter Arterial Chemoembolization Therapy In Combination with Sorafenib (TACTICS)
Acronym TACTICS
Scientific Title Phase II study: Transcatheter Arterial Chemoembolization Therapy In Combination with Sorafenib (TACTICS)
Scientific Title:Acronym TACTICS
Region
Japan

Condition
Condition HCC
Classification by specialty
Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the safety and efficacy of the combination therapy with TACE and sorafenib compared to TACE alone in patients with unresectable HCC who are not candidates for surgical resection or percutaneous ablation therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Time To Untreatable Progression(TTUP)
Key secondary outcomes Time to Progression(TTP)
Overall survival(OS)
Objective Response Rate(ORR)
Tumor markers
Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 TACE alone
Interventions/Control_2 TACE with Sorafenib
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) Patients aged 20 Years or over
2) Patients who were fully informed of the study beforehand and signed the informed consent to participate in the study.
3) Patients who are expected to live more than 12 weeks.
4) Patients diagnosed with typical HCC by biopsy,cytology, or diagnostic imaging such as dynamic CT(MRI).Typical HCC is defined by AASLD criteria.
5) Patients in whom complete resection of the tumor by hepatectomy or complete tumor necrosis by local tumor necrosis therapy(RFA) cannot be expected to succeed.
6) Patients with tumors which are confirmed to the liver and can be treated by TACE(the maximum diameter equal to or less than 10cm,and the maximum number of nodule equal to or less than 10).
7) Patients with viable and measurable target lesion.
8) patients with no or one history of TACE therapy.
9) patients with an ECOG PS(Performance Status) Score of 0 or 1.
10) patients with Child-Pugh class A.
11) Patients with laboratory values that meet the following criteria:
a.Hemoglobin >= 8.5 g/dl
b.Granulocytes >= 1500/mm3
c.Platelet count >= 50,000 /mm3
d.Total serum bilirubin =< 3 mg/dl
e.AST and ALT =< 6 times upper limits of normal
f.Serum creatinine =< 1.5 times upper limits of normal
Key exclusion criteria 1) History of malignant tumor
2) Severe cardiac disease
3) Serious and active infection, except for HBV and HCV
4) History of HIV infection
5) Renal dialysis
6) Diffuse tumor lesion
7) Extrahepatic metastasis
8) Vascular invasion
9) Intracranial tumor
10) Preexisting or history of hepatic encephalopathy
11) Clinically uncontrolled ascites or pleural effusion
12) Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
13) Esophageal and/or gastric varices which has high risk of bleeding
14) History of thrombosis and/or embolism within 6 months of the start of treatment
15) History of receiving any of the following therapies:
a) Systemic chemotherapy for advanced HCC
b) Local therapy, such as radiofrequency ablation, TACE, or hepatic arterial infusion within 3 months of the start of treatment
c) Current treatment with CYP3A4 inducing agents
d) Invasive surgery within 4 weeks of the start of treatment
e) History of allogenic transplantation
f) History of bone marrow transplant or haemopoietic stem cell transplant within 4 weeks of the start of this study
16) Unable to take oral medications
17) Gastrointestinal problems that may affect absorption or pharmacokinetics of the study drugs
18) Use of drugs that may affect absorption or pharmacokinetics of the study drugs
19) Concurrent disease or disability that may affect evaluation of the effects of the study drugs
20) Enrollment in another study within 4 weeks of study entry
21) Female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant
22) Risk of allergic reactions to the study drugs
23) Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results
24) Any condition that could jeopardize the safety of the patient or their compliance in the study
Target sample size 228

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Kudo
Organization Kinki University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 377-2, Oono-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan
TEL 072-366-0221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuomi Ueshima
Organization Kinki University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 377-2, Oono-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan
TEL 072-366-0221
Homepage URL
Email kaz-ues@med.kindai.ac.jp

Sponsor
Institute Japan Liver Oncology Group
Institute
Department

Funding Source
Organization Japan Liver Oncology Group
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2010 Year 10 Month 04 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 Open public recruiting
Date of protocol fixation
2010 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2010 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
2010 Year 10 Month 03 Day
Last modified on
2010 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005114

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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