Hepatocellular CarcinomaPhase 2NCT01170104
Trial of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib for Locally Advanced Hepatocellular Carcinoma (HCC)
A Phase 2 study testing Sorafenib and TACE (Transcatheter arterial chemoembolization) in people with Hepatocellular Carcinoma, run by Chung-Ang University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sorafenib and TACE (Transcatheter arterial chemoembolization)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2009to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- Signed and dated informed consent before the start of specific protocol procedures
Who cannot join
- 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.
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- 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).
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chung-Ang University Hospital
Dongjak, Seoul, 156-755
Joung-Soon Jang, M.D., 82-2-6299-1427, alsaba@daum.net
In Gyu Hwang, M.D., 82-2-748-9786, higyu72@yahoo.co.kr
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sorafenib, TACE (Transcatheter arterial chemoembolization)
- Keywords
- Hepatocellular Carcinoma, Sorafenib, TACE, locally, advanced Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
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)Procedure or surgery
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Assessments including image and laboratory studies will take place within 7days of the every TACE cycle
Measured: 2 year
Secondary outcomes (1)
To evaluate the toxicity profiles
Clinically assessed every TACE cycle
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionMay 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University
- Sponsor type
- University, hospital or other
- Collaborators
- Gyeongsang National University Hospital
- Investigators
- Joung-Soon Jang, M.D., Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170104
- Sponsor's protocol ID
- CAUHHO 2009-1
- Status last verified
- Jun 2009
- First submitted
- 23 Jul 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of TACE With Sorafenib in Patients With Locally Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01170104
- Acronym / sponsor ID
- CAUHHO 2009-1
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Sorafenib, TACE, locally, advanced Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Chung-Ang UniversityUniversity, hospital or other
- Collaborators
- Gyeongsang National University Hospital
- Study start
- Jun 2009
- Primary completion
- May 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SorafenibSorafenib (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). | Drug | – |
| 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). | Procedure or surgery | – |
Primary outcome
Time to progression
Time frame: 2 year
Assessments including image and laboratory studies will take place within 7days of the every TACE cycle
1 secondary outcome
To evaluate the toxicity profiles
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joung-Soon Jang, M.D. principal investigator
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib and TACE (Transcatheter arterial chemoembolization) in people with Hepatocellular Carcinoma, run by Chung-Ang University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joung-Soon Jang, M.D. (82-2-6299-1427, alsaba@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.