Trial of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib for Locally Advanced Hepatocellular Carcinoma (HCC)
NCT ID: NCT01170104
Last Updated: 2011-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
63 participants
INTERVENTIONAL
2009-06-30
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transarterial Chemoembolization (TACE) Plus Sorafenib Versus TACE for Advanced Hepatocellular Carcinoma
NCT02150317
TACE With or Without Sorafenib in Intermediate Stage Hepatocellular Carcinoma
NCT02529761
TACE Combined With Sorafenib and Tislelizumab for Advanced HCC
NCT04599777
Sorafenib Chemoembolization Evaluation Controlled Trial
NCT01906216
Combination of Transcatheter Arterial Chemoembolization (TACE) and Sorafenib for Patients With Unresectable Hepatocellular Carcinoma (HCC)
NCT00919009
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
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 Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gyeongsang National University Hospital
OTHER
Chung-Ang University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Chung-Ang University Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joung-Soon Jang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chung-Ang University Hospital
Dongjak, Seoul, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAUHHO 2009-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.