HCCNCT03985644
Multi-center Clinical Application of Hangzhou Criteria in Liver Transplantation for Hepatocellular Carcinoma
An observational study of HCC and Liver Transplantation, run by Zhejiang University.
Trial summary
Liver transplantation is an optimal radical therapy for selected patients with hepatocellular carcinoma. Hangzhou criteria could safely and effectively expand Milan criteria with expanded population and comparable survival. The purpose of this study was to evaluate the Hangzhou criteria in a multi-center cohort. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC, Liver Transplantation
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to 31 Dec 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥18 years and <=75 with HCC who underwent a primary whole or split liver transplant from a deceased donor were eligible for enrollment at the time of transplant. All of patients were histologically confirmed HCC by postoperative pathological examination in the participating centers. The donor-to-recipient arrangements all conformed to the principle of ABO compatibility. Key exclusion criteria were incomplete follow-up, missing essential data for analysis (tumor size, number, differentiation grade, α-fetoprotein (AFP)) or vascular invasion according to radiological criteria, and excludes those with perioperative mortality (<30 days)
Who may be able to join
- Aged ≥18 years and <=75 with HCC confirmed by histopathology;
- Undergoing a primary whole or split liver transplant from a deceased donor;
Who cannot join
- Incomplete follow-up;
- Missing essential data for analysis (tumor size, number, differentiation grade, α-fetoprotein (AFP)) ;
- Vascular invasion according to radiological criteria;
- Perioperative mortality (<30 days) ;
About this study
Official title: Multi-center Clinical Application of Hangzhou Criteria in Liver Transplant Candidate Selection for Hepatocellular Carcinoma
Liver transplantation is an optimal radical therapy for selected patients with hepatocellular carcinoma. Hangzhou criteria could safely and effectively expand Milan criteria with expanded population and comparable survival. The purpose of this study was to evaluate the Hangzhou criteria in a multi-center cohort.
Read the detailed description
Liver cancer is the sixth most commonly diagnosed cancer and the fourth leading cause of cancer-related deaths worldwide. Among all the liver cancer cases, hepatocellular carcinoma (HCC) constitutes 75-85%. Liver transplantation is the most effective treatment for HCC and is in high demand in China. The advent of Milan criteria has helped to select the recipients reasonably. However, the organ allocation system driven by the Milan criteria seemed to be too strict so that many centers worldwide have expanded the criteria in the aspects of morphological features, histopathology and biomarkers. Hangzhou criteria introduce the covariables of histopathologic grading and α-fetoprotein (AFP) into the selection of recipients for the first time. Based on the multi-center HCC patient cohort undergoing transplantation, this study aims to characterize an ideal candidate selecting system beyond the Milan criteria.
- Conditions
- HCC, Liver Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fulfilling Hangzhou criteria | Patients flfilling Hangzhou critieria: Without macrovascular invasion Tumor burden <=8 cm Preoperative AFP level <=400 ng/mL Histopathologic grades I, II | |
| Exceeding Hangzhou criteria | Patients exceeding Hangzhou critieria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival
Measured: 5 years
Secondary outcomes (1)
Recurrence rate
Recurrence rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study startJul 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985644
- Sponsor's protocol ID
- zju2017xux
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Application of Hangzhou Criteria in Liver Transplant Candidate Selection for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03985644
- Acronym / sponsor ID
- zju2017xux
- Conditions
- HCC, Liver Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Jun 2019 (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.
Liver transplantation is an optimal radical therapy for selected patients with hepatocellular carcinoma. Hangzhou criteria could safely and effectively expand Milan criteria with expanded population and comparable survival. The purpose of this study was to evaluate the Hangzhou criteria in a multi-center cohort.
Detailed description
Liver cancer is the sixth most commonly diagnosed cancer and the fourth leading cause of cancer-related deaths worldwide. Among all the liver cancer cases, hepatocellular carcinoma (HCC) constitutes 75-85%. Liver transplantation is the most effective treatment for HCC and is in high demand in China. The advent of Milan criteria has helped to select the recipients reasonably. However, the organ allocation system driven by the Milan criteria seemed to be too strict so that many centers worldwide have expanded the criteria in the aspects of morphological features, histopathology and biomarkers. Hangzhou criteria introduce the covariables of histopathologic grading and α-fetoprotein (AFP) into the selection of recipients for the first time. Based on the multi-center HCC patient cohort undergoing transplantation, this study aims to characterize an ideal candidate selecting system beyond the Milan criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fulfilling Hangzhou criteria | – | –Patients flfilling Hangzhou critieria: Without macrovascular invasion Tumor burden <=8 cm Preoperative AFP level <=400 ng/mL Histopathologic grades I, II |
| Exceeding Hangzhou criteria | – | –Patients exceeding Hangzhou critieria |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥18 years and <=75 with HCC who underwent a primary whole or split liver transplant from a deceased donor were eligible for enrollment at the time of transplant. All of patients were histologically confirmed HCC by postoperative pathological examination in the participating centers. The donor-to-recipient arrangements all conformed to the principle of ABO compatibility. Key exclusion criteria were incomplete follow-up, missing essential data for analysis (tumor size, number, differentiation grade, α-fetoprotein (AFP)) or vascular invasion according to radiological criteria, and excludes those with perioperative mortality (<30 days)
Key inclusion criteria (2 listed)
- Aged ≥18 years and <=75 with HCC confirmed by histopathology;
- Undergoing a primary whole or split liver transplant from a deceased donor;
Key exclusion criteria (4 listed)
- Incomplete follow-up;
- Missing essential data for analysis (tumor size, number, differentiation grade, α-fetoprotein (AFP)) ;
- Vascular invasion according to radiological criteria;
- Perioperative mortality (<30 days) ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 5 years
Overall survival
1 secondary outcome
Recurrence rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC and Liver Transplantation, run by Zhejiang University.
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 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: status not confirmed, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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: 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 14 Jun 2019.