Hepatocellular CarcinomaPhase 1NCT02724332
Adjuvant Anti-Recurrence Treatment With Rapamycin on Early-stage HCC
A Phase 1 study testing Rapamycin in people with Hepatocellular Carcinoma and Rapamycin, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
To evaluate the clinical effect of rapamycin combined with TACE on early-stage HCC with overexpression of ASPH after radical surgery using randomized controlled study and provide a new anti-recurrence treatment for HCC patients after operation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Rapamycin
- What is being tested?
- Rapamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Dec 2015
- Phase
- Phase 1
- 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
- Via clinical diagnosis and confirm it is primary liver cancer
- Pathological evidence of HCC
- Estimate tumor can gain treatment of curing operation
- No evidence for extrahepatic metestasis
- liver function ：Child-Pugh A/B
- BCLC stage：0/1；TNM stage：Ⅰ
Who cannot join
- reject to attend；
- impossible to come to our hospital for physical examination regularly.
- cancer epitome、seed focus、lymph node or distant metastasis
- Blood clotting function hindrance; 5, Patients with other diseases which may affect the treatment mentioned.
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
About this study
Official title: A Randomized Controlled Study on the Effect of Adjuvant Anti-recurrence Treatment With Rapamycin on Early-stage HCC With Overexpression of ASPH After Radical Surgery.
To evaluate the clinical effect of rapamycin combined with TACE on early-stage HCC with overexpression of ASPH after radical surgery using randomized controlled study and provide a new anti-recurrence treatment for HCC patients after operation.
- Conditions
- Hepatocellular Carcinoma, Rapamycin
- Being tested
- Rapamycin
- Keywords
- Aspartate beta hydroxylase, transcatheter arterial chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
2mg,po,bid
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients will be treated with radical hepatectomy only. |
| transcatheter arterial chemoembolization | Active comparator | Patients will be treated with TACE Receives: Drug: Rapamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 3 years
Secondary outcomes (1)
Time to recurrence
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 startNov 2012
- Primary completionJun 2015
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 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
- NCT02724332
- Sponsor's protocol ID
- ZD201206003-P1
- 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
- A Randomized Controlled Study on the Effect of Adjuvant Anti-recurrence Treatment With Rapamycin on Early-stage HCC With Overexpression of ASPH After Radical Surgery.
- ClinicalTrials.gov ID
- NCT02724332
- Acronym / sponsor ID
- ZD201206003-P1
- Conditions
- Hepatocellular Carcinoma, Rapamycin
- Keywords
- Aspartate beta hydroxylase, transcatheter arterial chemoembolization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (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.
To evaluate the clinical effect of rapamycin combined with TACE on early-stage HCC with overexpression of ASPH after radical surgery using randomized controlled study and provide a new anti-recurrence treatment for HCC patients after operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients will be treated with radical hepatectomy only. |
| transcatheter arterial chemoembolization | Active comparator | Drug: RapamycinPatients will be treated with TACE |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Via clinical diagnosis and confirm it is primary liver cancer
- Pathological evidence of HCC
- Estimate tumor can gain treatment of curing operation
- No evidence for extrahepatic metestasis
- liver function ：Child-Pugh A/B
Key exclusion criteria (4 listed)
- reject to attend；
- impossible to come to our hospital for physical examination regularly.
- cancer epitome、seed focus、lymph node or distant metastasis
- Blood clotting function hindrance; 5, Patients with other diseases which may affect the treatment mentioned.
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 |
|---|---|---|
| Rapamycin2mg,po,bid | Drug | transcatheter arterial chemoembolization |
Primary outcome
Overall Survival
Time frame: 3 years
1 secondary outcome
Time to recurrence
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 Phase 1 study testing Rapamycin in people with Hepatocellular Carcinoma and Rapamycin, 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 6 inclusion and 4 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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). 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.