Hepatocellular CarcinomaNCT02724358
Rg3 in Combination With TACE in Hepatocellular Carcinoma Patients With High Expression of Notch1
A study testing TACE, Rg3 and TACE + Rg3 in people with Hepatocellular Carcinoma and TACE, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
In order to provide a new option for clinical anti-angiogenesis therapy in hepatoma, a randomized controlled study is planed to confirm the effect of Rg3 in combination with TACE on angiogenesis and tumor treatment in advanced hepatocellular carcinoma patients with high expression of Notch1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, TACE, Notch1
- What is being tested?
- TACE, Rg3 and TACE + Rg3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed hepatocellular carcinoma.
- High expression of Notch1 in tumor tissues.
Who cannot join
- no pathological evidence of HCC
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
About this study
In order to provide a new option for clinical anti-angiogenesis therapy in hepatoma, a randomized controlled study is planed to confirm the effect of Rg3 in combination with TACE on angiogenesis and tumor treatment in advanced hepatocellular carcinoma patients with high expression of Notch1.
- Conditions
- Hepatocellular Carcinoma, TACE, Notch1, Rg3
- Being tested
- TACE, Rg3, TACE + Rg3, protective therapy
- Keywords
- Carcinoma, Hepatocellular, Notch1
- Medical subject headings
- Carcinoma, Hepatocellular, Bicuspid Aortic Valve Disease, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
Also called Transcatheter Arterial Chemoembolization
iodized oil (5ml) + Pirarubicin (20mg)
Rg3Drug
20mg, BID, maintained though Month 12.
TACE + Rg3Other
protective therapyProcedure or surgery
standard liver protective therapy
| Study group | Role | What they receive |
|---|---|---|
| TACE | Experimental | iodized oil (5ml) + Pirarubicin (20mg) Receives: Procedure: TACE |
| Rg3 | Experimental | 20mg, BID, maintained though Month 12 Receives: Drug: Rg3 |
| TACE + Rg3 | Experimental | the combination of the treatments for the above two groups. Rg3 will be stopped on the day performing TACE. Receives: Other: TACE + Rg3 |
| Control | Experimental | standard liver protective therapy Receives: Procedure: protective therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 3 years
Time to progression
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 posted31 Mar 2016 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724358
- Sponsor's protocol ID
- 2012ZX10002016008
- Status last verified
- Mar 2016
- First submitted
- 28 Mar 2016
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rg3 in Combination With TACE in Hepatocellular Carcinoma Patients With High Expression of Notch1
- ClinicalTrials.gov ID
- NCT02724358
- Acronym / sponsor ID
- 2012ZX10002016008
- Conditions
- Hepatocellular Carcinoma, TACE, Notch1, Rg3
- Keywords
- Carcinoma, Hepatocellular, Notch1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Mar 2016 (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.
In order to provide a new option for clinical anti-angiogenesis therapy in hepatoma, a randomized controlled study is planed to confirm the effect of Rg3 in combination with TACE on angiogenesis and tumor treatment in advanced hepatocellular carcinoma patients with high expression of Notch1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TACE | Experimental | Procedure: TACEiodized oil (5ml) + Pirarubicin (20mg) |
| Rg3 | Experimental | Drug: Rg320mg, BID, maintained though Month 12 |
| TACE + Rg3 | Experimental | Other: TACE + Rg3the combination of the treatments for the above two groups. Rg3 will be stopped on the day performing TACE. |
| Control | Experimental | Procedure: protective therapystandard liver protective therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pathologically confirmed hepatocellular carcinoma.
- High expression of Notch1 in tumor tissues.
Key exclusion criteria (1 listed)
- no pathological evidence of HCC
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 |
|---|---|---|
| TACEAlso: Transcatheter Arterial Chemoembolizationiodized oil (5ml) + Pirarubicin (20mg) | Procedure or surgery | TACE |
| Rg320mg, BID, maintained though Month 12. | Drug | Rg3 |
| TACE + Rg3 | Other | TACE + Rg3 |
| protective therapystandard liver protective therapy | Procedure or surgery | Control |
Primary outcome
Overall Survival
Time frame: 3 years
Time to progression
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 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.
The record lists no contact. Use the official record to reach the sponsor.
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, Rg3 and TACE + Rg3 in people with Hepatocellular Carcinoma and TACE, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 31 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 3 years). The study lists 2 primary outcomes in all. 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 31 Mar 2016.