Advanced Hepatocellular CarcinomaTACENCT02150317
Transarterial Chemoembolization (TACE) Plus Sorafenib Versus TACE for Advanced Hepatocellular Carcinoma
A study testing TACE+Sorafenib and TACE in people with Advanced Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) followed by Sorafenib with TACE alone in patients with advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- TACE+Sorafenib and TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2016
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients > 18 years and <=70 years of age.
- at least 2 radiologic imaging showing characteristic features of hepatocellular carcinoma or cytologic/histologic evidence.
- tumor in liver and radiologically definable vascular invasion or extrahepatic metastasis.
- Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
- No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
- Hb ≥90g/L,white blood cell count ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³
- Patients who can understand this trial and have signed information consent
Who cannot join
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
- Patients with other diseases which may affect the treatment mentioned.
- Patients with a medical history of other malignant tumors.
- Subjects participating in other clinical trials.
- liver function:Child C.
- no pathological evidence of hepatocellular carcinoma.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200438
Ai-jun Li, M.D., 0086-021-81875531, yinlei409@hotmail.com
Lei Yin, M.D., 0086-021-81875532, dermatology2008@126.com
About this study
Official title: A Prospective Randomized Trial Comparing Transcatheter Arterial Chemoembolization (TACE) Followed by Sorafenib Versus TACE Alone for Advanced Hepatocellular Carcinoma
The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) followed by Sorafenib with TACE alone in patients with advanced hepatocellular carcinoma.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- TACE+Sorafenib, TACE
- Keywords
- Carcinoma, Hepatocellular, Chemoembolization, Therapeutic, 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.
TACE+SorafenibProcedure or surgery
Also called TACE followed by Sorafenib
TACE followed by Sorafenib
TACEProcedure or surgery
TACE alone
| Study group | Role | What they receive |
|---|---|---|
| TACE+Sorafenib | Active comparator | TACE followed by Sorafenib Receives: Procedure: TACE+Sorafenib |
| TACE | Experimental | TACE alone Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
the overall survival rate of each group
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Ai-jun Li, M.D., Study chair, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150317
- Sponsor's protocol ID
- EHBHKY2013-001-08
- Acronym
- TACE
- Status last verified
- Mar 2016
- First submitted
- 26 May 2014
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Transcatheter Arterial Chemoembolization (TACE) Followed by Sorafenib Versus TACE Alone for Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02150317
- Acronym / sponsor ID
- TACE / EHBHKY2013-001-08
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- Carcinoma, Hepatocellular, Chemoembolization, Therapeutic, Sorafenib
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 May 2014 (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.
The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) followed by Sorafenib with TACE alone in patients with advanced hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE+Sorafenib | Active comparator | Procedure: TACE+SorafenibTACE followed by Sorafenib |
| TACE | Experimental | Procedure: TACETACE alone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients > 18 years and <=70 years of age.
- at least 2 radiologic imaging showing characteristic features of hepatocellular carcinoma or cytologic/histologic evidence.
- tumor in liver and radiologically definable vascular invasion or extrahepatic metastasis.
- Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
- No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
Key exclusion criteria (6 listed)
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
- Patients with other diseases which may affect the treatment mentioned.
- Patients with a medical history of other malignant tumors.
- Subjects participating in other clinical trials.
- liver function:Child C.
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 |
|---|---|---|
| TACE+SorafenibAlso: TACE followed by SorafenibTACE followed by Sorafenib | Procedure or surgery | TACE+Sorafenib |
| TACETACE alone | Procedure or surgery | TACE |
Primary outcome
the overall survival rate of each group
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
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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.
Ai-jun Li, M.D. study chair
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACE+Sorafenib and TACE in people with Advanced Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital 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 7 inclusion and 6 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 29 Mar 2016. 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.
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 Ai-jun Li, M.D. (0086-21-81875531, yinlei409@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the overall survival rate of each group (time frame: 3 years). 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 29 Mar 2016.