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Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib (TACTICS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01217034
Recruitment Status : Unknown
Verified October 2017 by Masatoshi Kudo, Japan Liver Oncology Group.
Recruitment status was:  Active, not recruiting
First Posted : October 8, 2010
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Masatoshi Kudo, Japan Liver Oncology Group

Tracking Information
First Submitted Date  ICMJE October 2, 2010
First Posted Date  ICMJE October 8, 2010
Last Update Posted Date October 31, 2017
Study Start Date  ICMJE October 2010
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • Progression Free Survival [ Time Frame: every 8 week ]
    Patients will be evaluated for these endpoints every 8 weeks
  • Overall Survival [ Time Frame: every 8 week ]
    The overall survival is defined as time from randomization to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period,respectively.
Original Primary Outcome Measures  ICMJE
 (submitted: October 6, 2010)
Time To Untreatable Progression(TTUP) [ Time Frame: every 8 week ]
Time to untreatable progression is defined as time from randomization to untreatable progression and will be evaluated every 8 week.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • Time To Progression [ Time Frame: every 8 weeks ]
    Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week.
  • Objective Response Rate [ Time Frame: 4week after TACE ]
    Objective Response Rate is defined as best response
  • Tumor markers [ Time Frame: every 4 weeks ]
    Change of tumor markers
  • Safety [ Time Frame: every 4 weeks ]
    Number of participants with adverse events as a measure of safety and tolerability(According to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)
  • Time To Untreatable Progression(TTUP) [ Time Frame: every 8 week till untreatable progression, assessed up to 100 months ]
    Time to untreatable progression is defined as time from randomization to untreatable progression and will be evaluated every 8 week.
  • Time to Child-Pugh C [ Time Frame: every 8 week till liver deterioration to Child-Pugh C, assessed up to 100 months ]
    Time to Child-Pugh C is defined as time from randomization to Child-Pugh C and will be evaluated every 8 week.
  • Time to intrahepatic tumor progression [ Time Frame: every 8 week till intrahepatic tumor progression, assessed up to 100 months ]
    Time to intrahepatic tumor progression is defined as time from randomization to intrahepatic tumor progression and will be evaluated every 8 week.
  • Time to vascular invasion [ Time Frame: every 8 week till vascular invasion, assessed up to 100 months ]
    Time to vascular invasion is defined as time from randomization to vascular invasion and will be evaluated every 8 week.
  • Time to Extrahepatic spread [ Time Frame: every 8 week till extrahepatic spread, assessed up to 100 months ]
    Time to extrahepatic spread is defined as time from randomization to extrahepatic spread and will be evaluated every 8 week.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2010)
  • Time To Progression [ Time Frame: every 8 weeks ]
    Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week.
  • Overall Survival [ Time Frame: every 8 week ]
    The overall survival is defined as time from randomization to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period,respectively.
  • Objective Response Rate [ Time Frame: 4week after TACE ]
  • Tumor markers [ Time Frame: every 4 weeks ]
  • Safety [ Time Frame: every 4 weeks ]
    Number of participants with adverse events as a measure of safety and tolerability(According to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib
Official Title  ICMJE Phase II Study: Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib (TACTICS)
Brief Summary The purpose of this study is to evaluate the safety and efficacy of the combination therapy with Transcatheter Arterial Chemoembolization (TACE) and sorafenib compared to TACE alone in patients with unresectable hepatocellular carcinoma (HCC) who are not candidates for surgical resection or percutaneous ablation therapy.
Detailed Description

TACE with sorafenib Group

Sorafenib will be administrated at a dose of 400mg o.d. before the first TACE. After 2days drug rest, TACE will be conducted. Sorafenib will be resumed at a dose of 400mg o.d. from 3 days after TACE(the resumption day can be postponed until 21 days after TACE). When tolerability is confirmed at 1 week after resumption, the dose of sorafenib will be increased to 400mg b.i.d. When tumor increases, TACE will be repeated.

Control group

TACE will be conducted at scheduled day. When tumor increases, TACE will be repeated.

The treatment regimen will be continued until untreatable progression which is defined as follows:

  • Child-Pugh grade C
  • Tumor growth (125 percent from baseline status)
  • Vascular invasion(Vp3,Vp4)
  • Extra hepatic spread which size is more than 10mm
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatocellular Carcinoma
  • Unresectable Hepatocellular Carcinoma
  • Carcinoma, Hepatocellular
  • Liver Neoplasm
Intervention  ICMJE
  • Drug: TACE with sorafenib
    Sorafenib will be administrated at a dose of 400mg o.d. before the first TACE. After 2days drug rest, TACE will be conducted. Sorafenib will be resumed at a dose of 400mg o.d. from 3 days after TACE(the resumption day can be postponed until 21 days after TACE). When tolerability is confirmed at 1 week after resumption, the dose of sorafenib will be increased to 400mg b.i.d. When tumor increases, TACE will be repeated.
    Other Name: TACE with Nexavar
  • Procedure: TACE alone
    TACE will be conducted at scheduled day. When tumor increases, TACE will be repeated.
    Other Name: TACE
Study Arms  ICMJE
  • Experimental: TACE with sorafenib
    TACE(on demand) with sorafenib till untreatable progression
    Intervention: Drug: TACE with sorafenib
  • Active Comparator: TACE alone
    TACE(on demand) till unreatable progression
    Intervention: Procedure: TACE alone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 6, 2010)
228
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    1. Hemoglobin ≥ 8.5 g/dl
    2. Granulocytes ≥ 1500/mm3
    3. Platelet count ≥ 50,000 /mm3
    4. Total serum bilirubin ≤ 3 mg/dl
    5. AST and ALT ≤ 6 times upper limits of normal
    6. Serum creatinine ≤ 1.5 times upper limits of normal

Exclusion Criteria:

  1. History of malignant tumor, excluding the following cases:

    1. Curatively treated early stage cancer with a low risk of recurrence ,such as carcinoma in situ of the cervix, basal cell carcinoma, superficial bladder tumor, and early gastric cancer.
    2. Malignant tumor that was curatively treated more than 3 years prior to study entry and has not recurred since then
  2. Cardiac disease that meet any of the following criteria:

    1. NYHA Class III or higher congestive heart failure
    2. History of symptomatic coronary artery disease or myocardial infarction within 6 months before enrollment
    3. Arrhythmia requiring control by antiarrhythmic drugs such as beta-blockers or digoxin
  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:

    1. Systemic chemotherapy for advanced HCC(including sorafenib therapy)
    2. Local therapy, such as radiofrequency ablation, TACE, or hepatic arterial infusion within 3 months of the start of treatment
    3. Current treatment with CYP3A4 inducing agents
    4. Invasive surgery within 4 weeks of the start of treatment
    5. History of allogenic transplantation
    6. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01217034
Other Study ID Numbers  ICMJE JLOG 1001 trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Masatoshi Kudo, Japan Liver Oncology Group
Original Responsible Party Japan Liver Oncology Group, Non-profit Organization
Current Study Sponsor  ICMJE Japan Liver Oncology Group
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Masatoshi Kudo, Professor Japan Liver Oncology Group
PRS Account Japan Liver Oncology Group
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP