PHENYTOIN/SORAFENIB [VA Drug Interaction]Phase 2NCT01605734
TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma
A Phase 2 study testing TACE and sorafenib combined with TACE in people with PHENYTOIN/SORAFENIB [VA Drug Interaction] and Carcinoma, Hepatocellular, run by Shandong Cancer Hospital and Institute at 5 sites in China.
Trial summary
TACE is widely used in patients with unresectable HCC. However, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed. Sorafenib is regarded as standard treatment for advanced HCC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PHENYTOIN/SORAFENIB [VA Drug Interaction], Carcinoma, Hepatocellular
- What is being tested?
- TACE and sorafenib combined with TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesChina
- Study dates
- Jul 2012to Dec 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
- BCLC stage B or C
- Child-Pugh class score≤8
- ECOG performance status ≤2
- Etiology: Hepatitis B virus(HBV) infection
- Written informed consent (approved by the Institutional Review Board [IRB]obtained prior to any study specific screening procedures
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- Patient must be able to comply with the protocol
- Age 18-75 years
- Haematology:Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count > 50 x 109/L, Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1.5
- Biochemistry:Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)< 5 x the upper limit of normal,Total bilirubin < 3 x the upper limit of normal,Serum creatinine < 1.5 x the upper limit of normal,Cholinesterase>0.5x the lower limit of normal，Prealbumin>0.5x the lower limit of normal.
- Life expectancy of > 3 months
Who cannot join
- BCLC stage D
- Child-Pugh Score≥9
- Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
- Preexisting or history of hepatic encephalopathy
- uncontrolled hypertension
- Pregnancy (positive serum pregnancy test) or lactation
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- Serious, non-healing wound, ulcer, or bone fracture
- Currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study
- Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
- Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Sorafenib/TACE or patient at high risk from treatment complications
- Other severe concomitant disease that may reduce life expectancy
- Risk of allergic reactions to the study drugs
- Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Shandong Medical Imaging Research Institute
Jinan, Shandong, 250021
Jun Tang, MD, +8613964031909, tangjun7925032@163.com
Jun Tang, MD
Qilu Hospital of Shandong University
Jinan, Shandong, 250114
Caixia Li, MD, +8613505312972, Lilyshanda88@hotmail.com
Caixia Li, MD
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
the Affiliated Hospital of Medical College Qingdao University
Qingdao, Shandong, 266003
Zixiang Li, MD, +8618669739263, zixiangli@yahoo.com.cn
Zixiang Li, MD
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Yanbo Zheng, MD, +8613805356068, 13805356068@163.com
Yanbo Zheng
About this study
Official title: Phase II Trail of TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma
TACE is widely used in patients with unresectable HCC. However, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed. Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that the combination of TACE with sorafenib could improve the survival of patients with unresectable HCC.
- Being tested
- TACE, sorafenib combined with TACE
- Keywords
- hepatocellular carcinoma, transarterial chemoembolization, sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
After obtaining arterial access,a diagnostic visceral arteriogram will be performed to demonstrate arterial supply to the tumor and the presence of variant arterial anatomy.After having positioned the catheter within the artery feeding tumor,the chemoembolization mixture will be infused into th e artery until stagnant flow is observed.
sorafenib combined with TACEDrug
All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study
| Study group | Role | What they receive |
|---|---|---|
| Group TACE | Active comparator | TACE will be carried out with chemotherapeutic agents and lipiodol; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated if clinically indicated Receives: Procedure: TACE |
| Group Combination | Experimental | All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study Receives: Drug: sorafenib combined with TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression
Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week
Measured: 1 year
Secondary outcomes (6)
FACT-Hep
FACT-Hep is a chart established to evaluate the life quality of patients with HCC every 4 weeks
Measured: six months
Disease control rate
CR+PR+SD
Measured: six months after TACE
Safety
Number of participants with adverse events as a measure of safety and tolerability(According to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)
Measured: six months
PFS and OS
The overall survival is defined as time from randomization to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period,respectively
Measured: two years
Number of TACE sessions and the interval time between two TACE sessions
Measured: 2 years
AFP
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PHENYTOIN/SORAFENIB [VA Drug Interaction]Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinlong Song, Shandong Cancer Hospital and Institute
- Investigators
- Jinlong Song, MD, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605734
- Sponsor's protocol ID
- ShandongCHI-002
- Status last verified
- May 2012
- First submitted
- 11 May 2012
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trail of TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01605734
- Acronym / sponsor ID
- ShandongCHI-002
- Keywords
- hepatocellular carcinoma, transarterial chemoembolization, sorafenib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 May 2012 (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.
TACE is widely used in patients with unresectable HCC. However, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed. Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that the combination of TACE with sorafenib could improve the survival of patients with unresectable HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group TACE | Active comparator | Procedure: TACETACE will be carried out with chemotherapeutic agents and lipiodol; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated if clinically indicated |
| Group Combination | Experimental | Drug: sorafenib combined with TACEAll patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
- BCLC stage B or C
- Child-Pugh class score≤8
- ECOG performance status ≤2
- Etiology: Hepatitis B virus(HBV) infection
Key exclusion criteria (13 listed)
- BCLC stage D
- Child-Pugh Score≥9
- Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
- Preexisting or history of hepatic encephalopathy
- uncontrolled hypertension
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 |
|---|---|---|
| TACEAfter obtaining arterial access,a diagnostic visceral arteriogram will be performed to demonstrate arterial supply to the tumor and the presence of variant arterial anatomy.After having positioned the catheter within the artery feeding tumor,the chemoembolization mixture will be infused into th e artery until stagnant flow is observed. | Procedure or surgery | Group TACE |
| sorafenib combined with TACEAll patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study | Drug | Group Combination |
Primary outcome
Time to Progression
Time frame: 1 year
Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week
6 secondary outcomes
FACT-Hep
Time frame: six months
Disease control rate
Time frame: six months after TACE
Safety
Time frame: six months
PFS and OS
Time frame: two years
Number of TACE sessions and the interval time between two TACE sessions
Time frame: 2 years
AFP
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2012.
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.
Jinlong Song, MD principal investigator
Shandong Cancer Hospital and Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TACE and sorafenib combined with TACE in people with PHENYTOIN/SORAFENIB [VA Drug Interaction] and Carcinoma, Hepatocellular, run by Shandong Cancer Hospital and Institute at 5 sites in China.
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 11 inclusion and 13 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 25 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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 Jinlong Song, MD (+8653167626411, songjlmd@gmail.com), 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: 1 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 25 May 2012.