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
1 other identifier
interventional
63
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hepatocellular-carcinoma
Started Jun 2009
Typical duration for phase_2 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 23, 2010
CompletedFirst Posted
Study publicly available on registry
July 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJune 23, 2011
June 1, 2009
2.9 years
July 23, 2010
June 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to progression
Assessments including image and laboratory studies will take place within 7days of the every TACE cycle
2 year
Secondary Outcomes (1)
To evaluate the toxicity profiles
2 year
Interventions
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).
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 Criteria
You may qualify if:
- Unresectable Hepatocellular carcinoma with local liver lesion treatable with TACE
- Age \> 18 years.
- ECOG Performance Status of 0 or 1.
- Child-Pugh class A (class B could be included when Childs score is 7).
- Life expectancy of at least 12 weeks.
- Subjects with at least one measurable lesion.
- 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
- +1 more criteria
You may not qualify if:
- 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.
- History of HIV infection.
- Active clinically serious infections (\> grade 2 NCI-CTC version 3.0)
- 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)
- Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- History of organ allograft The organ allograft may be allowed as protocol specific.
- Patients with evidence or history of uncontrolled bleeding diathesis
- Patients undergoing renal dialysis
- 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.
- 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).
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chung-Ang Universitylead
- Gyeongsang National University Hospitalcollaborator
Study Sites (1)
Chung-Ang University Hospital
Dongjak, Seoul, 156-755, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joung-Soon Jang, M.D.
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 23, 2010
First Posted
July 27, 2010
Study Start
June 1, 2009
Primary Completion
May 1, 2012
Study Completion
June 1, 2013
Last Updated
June 23, 2011
Record last verified: 2009-06