Trial of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib for Locally Advanced Hepatocellular Carcinoma (HCC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Chung-Ang University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Gyeongsang National University Hospital
Information provided by:
Chung-Ang University
ClinicalTrials.gov Identifier:
NCT01170104
First received: July 23, 2010
Last updated: June 22, 2011
Last verified: June 2009
  Purpose

To evaluate the time to progression of the combination therapy of Transcatheter Arterial Chemoembolization (TACE) and sorafenib in patients with previously untreated advanced or metastatic hepatocellular carcinoma.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Sorafenib
Procedure: TACE (Transcatheter arterial chemoembolization)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of TACE With Sorafenib in Patients With Locally Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Chung-Ang University:

Primary Outcome Measures:
  • Time to progression [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    Assessments including image and laboratory studies will take place within 7days of the every TACE cycle


Secondary Outcome Measures:
  • To evaluate the toxicity profiles [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    Clinically assessed every TACE cycle


Estimated Enrollment: 63
Study Start Date: June 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sorafenib
    Sorafenib (NEXAVAR, Bayer) will be administered after TACE continuous dosing from day 1 until progression or up to 6 cycles of TACE as an oral 400mg twice-daily without food (at least 1 hour before or 2 hours after eating).
    Procedure: TACE (Transcatheter arterial chemoembolization)
    Sorafenib (NEXAVAR, Bayer) will be administered after TACE continuous dosing from day 1 until progression or up to 6 cycles of TACE as an oral 400mg twice-daily without food (at least 1 hour before or 2 hours after eating).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Unresectable Hepatocellular carcinoma with local liver lesion treatable with TACE
  2. Age > 18 years.
  3. ECOG Performance Status of 0 or 1.
  4. Child-Pugh class A (class B could be included when Childs score is 7).
  5. Life expectancy of at least 12 weeks.
  6. Subjects with at least one measurable lesion.
  7. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

    • Hemoglobin > 9.0 g/dl
    • Absolute neutrophil count (ANC) >1,500/mm3
    • Platelet count > 75,000/μl
    • Total bilirubin < 1.5 times the upper limit of normal
    • ALT and AST < 2.5 x upper limit of normal (UNL)
    • Alkaline phosphatase < 5 x ULN
    • PT-INR/PTT < 1.5 x upper limit of normal
    • Serum creatinine < 1.5 x ULN
  8. Signed and dated informed consent before the start of specific protocol procedures

Exclusion Criteria:

  1. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy( beta blockers or digoxin are permitted) or uncontrolled hypertension.
  2. History of HIV infection.
  3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  4. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
  5. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
  6. History of organ allograft The organ allograft may be allowed as protocol specific.
  7. Patients with evidence or history of uncontrolled bleeding diathesis
  8. Patients undergoing renal dialysis
  9. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
  10. Excluded therapies and medications, previous and concomitant:

    • Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry
    • Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 4 weeks of start of study
    • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
    • Prior exposure to the study drug.
    • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial (and men for at least 3 months after last administration of study medication).
    • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
    • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
    • Patients unable to swallow oral medications
  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: NCT01170104

Contacts
Contact: Joung-Soon Jang, M.D. 82-2-6299-1427 alsaba@daum.net
Contact: In Gyu Hwang, M.D. 82-2-748-9786 higyu72@yahoo.co.kr

Locations
Korea, Republic of
Chung-Ang University Hospital Recruiting
Dongjak, Seoul, Korea, Republic of, 156-755
Contact: Joung-Soon Jang, M.D.    82-2-6299-1427    alsaba@daum.net   
Contact: In Gyu Hwang, M.D.    82-2-748-9786    higyu72@yahoo.co.kr   
Principal Investigator: Joung-Soon Jang, M.D.         
Sub-Investigator: Hyung Joon Kim, M.D.         
Sub-Investigator: Hyun Woong Lee, M.D.         
Sub-Investigator: In Gyu Hwang, M.D.         
Sponsors and Collaborators
Chung-Ang University
Gyeongsang National University Hospital
Investigators
Principal Investigator: Joung-Soon Jang, M.D. Chung-Ang University Hospital
  More Information

No publications provided

Responsible Party: Joung-Soon Jang/Professor, Chung-Ang University Hospital
ClinicalTrials.gov Identifier: NCT01170104     History of Changes
Other Study ID Numbers: CAUHHO 2009-1
Study First Received: July 23, 2010
Last Updated: June 22, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Chung-Ang University:
Hepatocellular Carcinoma
Sorafenib
TACE
locally, advanced Hepatocellular Carcinoma

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

ClinicalTrials.gov processed this record on July 24, 2014