PHENYTOIN/SORAFENIB [VA Drug Interaction]Phase 2NCT01556815
Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma
A Phase 2 study testing Transarterial Chemoembolization (TACE) and Sorafenib in combination with TACE in people with PHENYTOIN/SORAFENIB [VA Drug Interaction] and Liver Neoplasms, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell proliferation and angiogenesis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PHENYTOIN/SORAFENIB [VA Drug Interaction], Liver Neoplasms, Carcinoma, Hepatocellular
- What is being tested?
- Transarterial Chemoembolization (TACE) and Sorafenib in combination with TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- May 2012to May 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 80 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
- Child-Pugh class A
- ECOG performance status of 0
- 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 18-80 years
- Haematology:Absolute neutrophil count (ANC) > 1 x 109/L, Platelet count > 40 x 109/L, Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1.5
- Biochemistry:Total bilirubin < 2 mg/dL Serum creatinine < 1.5 x the upper limit of normal
- Life expectancy of > 3 months
Who cannot join
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 x the upper limit of normal
- Other severe concomitant disease that may reduce life expectancy
- uncontrolled hypertension
- Pregnancy (positive serum pregnancy test) or lactation
- Uncontrolled hypertension
- Serious, non-healing wound, ulcer, or bone fracture
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Wenbo Shao, MD, Ph D, +8653167626412, shaowenbomd@gmail.com
Jinlong Song, MD
About this study
Official title: Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may benefit from sorafenib in combination with TACE.
- Conditions
- PHENYTOIN/SORAFENIB [VA Drug Interaction], Liver Neoplasms, Carcinoma, Hepatocellular, Digestive System Neoplasms, Neoplasms by Site, Liver Diseases
- Being tested
- Transarterial Chemoembolization (TACE), Sorafenib in combination with TACE
- Keywords
- Hepatocellular Carcinoma, Sorafenib, Transarterial Chemoembolization, HBV
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular, Digestive System Neoplasms, Neoplasms by Site, Liver Diseases, Adenocarcinoma, Carcinoma, Neoplasms, Glandular and Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial Chemoembolization (TACE)Procedure or surgery
Procedure:TACE TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated .
Sorafenib in combination with TACEOther
Also called Sorafenib:Nexavar(brand name)
Drug: Sorafenib All patients will receive Sorafenib (800 mg/day) p.o. beginning one week after the first TACE and every day thereafter until patient death or premature withdrawal from study.
Procedure: TACE
TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated .
| Study group | Role | What they receive |
|---|---|---|
| Group TACE | Active comparator | Patients who undergo TACE Receives: Procedure: Transarterial Chemoembolization (TACE) |
| Group Combination | Experimental | Patients who are treated with sorafenib combined with TACE Receives: Other: Sorafenib in combination with TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)
Measure:time-to-proression
Measured: 1 year
Secondary outcomes (2)
safety of sorafenib in combination with TACE
Measure: incidence and grade of adverse events in patients treated with sorafenib combined with TACE (group B)
Measured: 6 months
Survival in the two treatment groups
Measured from the date of TACE until the date of death or last visit
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2014 (estimated)
- Study completionMay 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
- 40 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
- NCT01556815
- Sponsor's protocol ID
- ShandongCHI-001
- Status last verified
- Apr 2012
- First submitted
- 14 Mar 2012
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01556815
- Acronym / sponsor ID
- ShandongCHI-001
- Conditions
- PHENYTOIN/SORAFENIB [VA Drug Interaction], Liver Neoplasms, Carcinoma, Hepatocellular, Digestive System Neoplasms, Neoplasms by Site, Liver Diseases
- Keywords
- Hepatocellular Carcinoma, Sorafenib, Transarterial Chemoembolization, HBV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 16 Mar 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.
Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may benefit from sorafenib in combination with TACE.
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: Transarterial Chemoembolization (TACE)Patients who undergo TACE |
| Group Combination | Experimental | Other: Sorafenib in combination with TACEPatients who are treated with sorafenib combined with TACE |
Who may qualify
- Ages
- 18 to 80 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
- Child-Pugh class A
- ECOG performance status of 0
- Etiology: Hepatitis B virus(HBV) infection
Key exclusion criteria (9 listed)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 x the upper limit of normal
- Other severe concomitant disease that may reduce life expectancy
- uncontrolled hypertension
- Pregnancy (positive serum pregnancy test) or lactation
- 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 |
|---|---|---|
| Transarterial Chemoembolization (TACE)Procedure:TACE TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated . | Procedure or surgery | Group TACE |
| Sorafenib in combination with TACEAlso: Sorafenib:Nexavar(brand name)Drug: Sorafenib All patients will receive Sorafenib (800 mg/day) p.o. beginning one week after the first TACE and every day thereafter until patient death or premature withdrawal from study. Procedure: TACE TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated . | Other | Group Combination |
Primary outcome
Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)
Time frame: 1 year
Measure:time-to-proression
2 secondary outcomes
safety of sorafenib in combination with TACE
Time frame: 6 months
Survival in the two treatment groups
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 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
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 Transarterial Chemoembolization (TACE) and Sorafenib in combination with TACE in people with PHENYTOIN/SORAFENIB [VA Drug Interaction] and Liver Neoplasms, run by Shandong Cancer Hospital and Institute at 1 site 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 9 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 Apr 2012. 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 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?
Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE) (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 Apr 2012.