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

July 23, 2010
June 22, 2011
June 2009
May 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01170104 on ClinicalTrials.gov Archive Site
To evaluate the toxicity profiles [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Clinically assessed every TACE cycle
Same as current
Not Provided
Not Provided
 
Trial of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib for Locally Advanced Hepatocellular Carcinoma (HCC)
Phase II Trial of TACE With Sorafenib in Patients With Locally Advanced Hepatocellular Carcinoma

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • 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).
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
63
June 2013
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Korea, Republic of
 
NCT01170104
CAUHHO 2009-1
No
Joung-Soon Jang/Professor, Chung-Ang University Hospital
Chung-Ang University
Gyeongsang National University Hospital
Principal Investigator: Joung-Soon Jang, M.D. Chung-Ang University Hospital
Chung-Ang University
June 2009

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