Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib (TACTICS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2010 by Japan Liver Oncology Group
Sponsor:
Information provided by:
Japan Liver Oncology Group
ClinicalTrials.gov Identifier:
NCT01217034
First received: October 2, 2010
Last updated: October 6, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Unresectable Hepatocellular Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasm
Drug: TACE with sorafenib
Procedure: TACE alone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study: Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib (TACTICS)

Resource links provided by NLM:


Further study details as provided by Japan Liver Oncology Group:

Primary Outcome Measures:
  • Time To Untreatable Progression(TTUP) [ Time Frame: every 8 week ] [ Designated as safety issue: No ]
    Time to untreatable progression is defined as time from randomization to untreatable progression and will be evaluated every 8 week.


Secondary Outcome Measures:
  • Time To Progression [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Tumor markers [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 228
Study Start Date: October 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TACE with sorafenib 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
Active Comparator: TACE alone Procedure: TACE alone
TACE will be conducted at scheduled day. When tumor increases, TACE will be repeated.
Other Name: TACE

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
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217034

Contacts
Contact: Masatoshi Kudo, Professor +81-72-366-0221 ext 3149 m-kudo@med.kindai.ac.jp
Contact: Kazuomi Ueshima +81-72-366-0221 ext 3525 kaz-ues@med.kindai.ac.jp

Locations
Japan
Kinki University Hospital Recruiting
Osaka-Sayama, Osaka, Japan, 589-8511
Contact: Masatoshi Kudo, Professor    +81-72-366-0221 ext 3149    m-kudo@med.kindai.ac.jp   
Contact: Kazuomi Ueshima    +81-72-366-0221 ext 3525    kaz-ues@med.kindai.ac.jp   
Principal Investigator: Masatoshi Kudo, Professor         
Sub-Investigator: Kazuomi Ueshima, M.D.         
Sponsors and Collaborators
Japan Liver Oncology Group
Investigators
Principal Investigator: Masatoshi Kudo, Professor Japan Liver Oncology Group
  More Information

No publications provided

Responsible Party: Japan Liver Oncology Group, Non-profit Organization
ClinicalTrials.gov Identifier: NCT01217034     History of Changes
Other Study ID Numbers: JLOG 1001 trial
Study First Received: October 2, 2010
Last Updated: October 6, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Liver Oncology Group:
Transcatheter arterial chemoembolization
TACE
sorafenib
Time to untreatable progression
TTUP

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms
Carcinoma
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014