Liver TransplantationNCT06564103
Stratification for F-L Therapy After LT
An observational study of Liver Transplantation and Adjuvant FOLFOX Plus Lenvatinib, run by Xiao Xu at 1 site in China.
Trial summary
Objective: To stratify recipients who underwent adjuvant FOLFOX plus lenvatinib (F-L) therapy following liver transplantation (LT) for hepatocellular carcinoma and provide guidance for clinical adjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation, Adjuvant FOLFOX Plus Lenvatinib, Machine Learning
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 5 Aug 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 70 years
- All sexes
- Adult, Older adult
Study population: Recipients at Shulan (Hangzhou) Hospital from January 2017 to December 2021 were included in the analysis, which comprised 106 recipients in the F-L therapy group and 229 non-adjuvant (N-A) therapy group recipients.
Who may be able to join
- patients fulfilling the Hangzhou criteria or exceeding the Hangzhou criteria with type 1 or 2 portal vein tumor thrombus (PVTT) before LT
Who cannot join
- 1) individuals less than 18 years old; 2) individuals with malignancies other than HCC; 3) individuals who survived less than 30 days after LT; and 4) individuals who lacked important prognostic variables, such as contrast-enhanced CT imaging information one month before transplantation, preoperative alpha-fetoprotein (AFP) levels, and tumor differentiation data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stratification for Efficacy of Adjuvant FOLFOX Plus Lenvatinib After Liver Transplantation for Hepatocellular Carcinoma in Recurrence Prevention
Objective: To stratify recipients who underwent adjuvant FOLFOX plus lenvatinib (F-L) therapy following liver transplantation (LT) for hepatocellular carcinoma and provide guidance for clinical adjuvant therapy.
Methods: Liver recipients in the Shulan (Hangzhou) Hospital from January, 2017 to December, 2021, including 106 in the F-L therapy group and 229 in the non-adjuvant (N-A) therapy group were included in the analysis. A 1:1 propensity score matching (PSM) analysis was performed to minimize group imbalances. Disease-free survival (DFS) and overall survival (OS) were compared among recipients. Radiomics features that demonstrated predictive value for recurrence were employed, either independently or in conjunction with prognostic clinical features, to formulate predictive models. The combined model was used to perform further subgroup analysis for recipients in the F-L therapy group.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination product
| Study group | Role | What they receive |
|---|---|---|
| adjuvant FOLFOX plus lenvatinib therapy group | Not described | |
| non-adjuvant therapy group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The disease-free survival rate was evaluated by follow-up investigation and outpatient review
Measured: 1-5 years
Secondary outcomes (1)
The overall survival rate was evaluated by follow-up investigation and outpatient review
Measured: 1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Jan 2024
- Primary completion1 Aug 2024
- Study completion5 Aug 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.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiao Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564103
- Sponsor's protocol ID
- CT2024-ZJU-OBS10
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratification for Efficacy of Adjuvant FOLFOX Plus Lenvatinib After Liver Transplantation for Hepatocellular Carcinoma in Recurrence Prevention
- ClinicalTrials.gov ID
- NCT06564103
- Acronym / sponsor ID
- CT2024-ZJU-OBS10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Xiao XuUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 21 Aug 2024 (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.
Objective: To stratify recipients who underwent adjuvant FOLFOX plus lenvatinib (F-L) therapy following liver transplantation (LT) for hepatocellular carcinoma and provide guidance for clinical adjuvant therapy.
Methods: Liver recipients in the Shulan (Hangzhou) Hospital from January, 2017 to December, 2021, including 106 in the F-L therapy group and 229 in the non-adjuvant (N-A) therapy group were included in the analysis. A 1:1 propensity score matching (PSM) analysis was performed to minimize group imbalances. Disease-free survival (DFS) and overall survival (OS) were compared among recipients. Radiomics features that demonstrated predictive value for recurrence were employed, either independently or in conjunction with prognostic clinical features, to formulate predictive models. The combined model was used to perform further subgroup analysis for recipients in the F-L therapy group.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adjuvant FOLFOX plus lenvatinib therapy group | – | – |
| non-adjuvant therapy group | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Recipients at Shulan (Hangzhou) Hospital from January 2017 to December 2021 were included in the analysis, which comprised 106 recipients in the F-L therapy group and 229 non-adjuvant (N-A) therapy group recipients.
Key inclusion criteria (1 listed)
- patients fulfilling the Hangzhou criteria or exceeding the Hangzhou criteria with type 1 or 2 portal vein tumor thrombus (PVTT) before LT
Key exclusion criteria (1 listed)
- 1) individuals less than 18 years old; 2) individuals with malignancies other than HCC; 3) individuals who survived less than 30 days after LT; and 4) individuals who lacked important prognostic variables, such as contrast-enhanced CT imaging information one month before transplantation, preoperative alpha-fetoprotein (AFP) levels, and tumor differentiation data
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 |
|---|---|---|
| Combination product | non-adjuvant therapy group |
Primary outcome
The disease-free survival rate was evaluated by follow-up investigation and outpatient review
Time frame: 1-5 years
1 secondary outcome
The overall survival rate was evaluated by follow-up investigation and outpatient review
Time frame: 1-5 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 21 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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 and Adjuvant FOLFOX Plus Lenvatinib, run by Xiao Xu 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 1 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 21 Aug 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?
The disease-free survival rate was evaluated by follow-up investigation and outpatient review (time frame: 1-5 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 21 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.