UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004316 |
|---|---|
| Receipt number | 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 | 2023/01/05 10:01:56 |
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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
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
kaz-ues@med.kindai.ac.jp
Sponsor or person
Institute
Japan Liver Oncology Group
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
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
| 2023 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005114
