Liver TransplantationNCT05448339
Tumor Feeding Vessels Deprivation Combined With Tyrosine Kinase Inhibitor in Liver Transplantation
An observational study of Liver Transplantation, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To investigate the value of tumor feeding vessels deprivation combined with tyrosine kinase inhibitor in liver transplantation. Patients are enrolled into two groups according to the downstaging therapy they undergo before transplantion. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- PVHA or TACE
- How many people
- 197 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to 1 Jan 2024
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: (1) age ≥18 years; (2) exceeding UCSF criteria; (3) absence of vascular invasion, nodal involvement, or extrahepatic metastases; (4) receiving TACE treatment or LTFVD treatment for downstaging purposes. Patients who underwent resection, LT, or any form of downstaging treatment prior to enrollment were excluded.
(1) age ≥18 years; (2) exceeding UCSF criteria; (3) absence of vascular invasion, nodal involvement, or extrahepatic metastases; (4) receiving TACE treatment or LTFVD treatment for downstaging purposes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Tumor Feeding Vessels Deprivation Combined With Tyrosine Kinase Inhibitor in Liver Transplantation
To investigate the value of tumor feeding vessels deprivation combined with tyrosine kinase inhibitor in liver transplantation. Patients are enrolled into two groups according to the downstaging therapy they undergo before transplantion.
- Conditions
- Liver Transplantation
- Being tested
- PVHA or TACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVHA or TACECombination product
PVHA or TACE
| Study group | Role | What they receive |
|---|---|---|
| PVHA | Patients undergo tumor feeding vessels deprivation Receives: Combination Product: PVHA or TACE | |
| TACE | Patients undergo TACE therapy Receives: Combination Product: PVHA or TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Underwent LT
Underwent LT
Measured: January 2013 and December 2020
Successful downstaging
Successful downstaging
Measured: January 2013 and December 2020
Secondary outcomes (3)
AFP reduction of patients
AFP reduction of patients
Measured: January 2013 and December 2020
Survival time of patients
Survival time of patients
Measured: January 2013 and December 2020
Recurrence of patients
Recurrence of patients
Measured: January 2013 and December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Jan 2013
- Primary completion31 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Zhong, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448339
- Sponsor's protocol ID
- SHLTQC-5
- Status last verified
- Jan 2024
- First submitted
- 29 Jun 2022
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Tumor Feeding Vessels Deprivation Combined With Tyrosine Kinase Inhibitor in Liver Transplantation
- ClinicalTrials.gov ID
- NCT05448339
- Acronym / sponsor ID
- SHLTQC-5
- Conditions
- Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 7 Jul 2022 (actual)
- 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 investigate the value of tumor feeding vessels deprivation combined with tyrosine kinase inhibitor in liver transplantation. Patients are enrolled into two groups according to the downstaging therapy they undergo before transplantion.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVHA | – | Combination Product: PVHA or TACEPatients undergo tumor feeding vessels deprivation |
| TACE | – | Combination Product: PVHA or TACEPatients undergo TACE therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- (1) age ≥18 years; (2) exceeding UCSF criteria; (3) absence of vascular invasion, nodal involvement, or extrahepatic metastases; (4) receiving TACE treatment or LTFVD treatment for downstaging purposes. Patients who underwent resection, LT, or any form of downstaging treatment prior to enrollment were excluded.
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 |
|---|---|---|
| PVHA or TACEPVHA or TACE | Combination product | PVHA, TACE |
Primary outcome
Underwent LT
Time frame: January 2013 and December 2020
Underwent LT
Successful downstaging
Time frame: January 2013 and December 2020
Successful downstaging
3 secondary outcomes
AFP reduction of patients
Time frame: January 2013 and December 2020
Survival time of patients
Time frame: January 2013 and December 2020
Recurrence of patients
Time frame: January 2013 and December 2020
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 9 Jan 2024.
- Individual participant dataSharing planned: No
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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?
An observational study of Liver Transplantation, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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?
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 9 Jan 2024. 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?
Underwent LT (time frame: January 2013 and December 2020). 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 9 Jan 2024.