Liver TransplantNCT06928415
Efficacy and Safety of Liver Transplantation for Hepatocellular Carcinoma With Bile Duct Tumor Thrombus: a Single-arm, Multicenter, Prospective Study (HCC-BDTT in LT)
An observational study of Liver Transplant and Hepatocellular Carcinoma, run by Zhejiang University.
Trial summary
The prognosis for patients diagnosed with hepatocellular carcinoma with bile duct tumor thrombus (BDTT-HCC) remains notably grim, as there are presently no universally accepted treatment guidelines in place to address this complex condition. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplant, Hepatocellular Carcinoma, Bile Duct Tumor Thrombus
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2025to 10 Jan 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: HCC and BDTT patients in LT
Who may be able to join
- age between 18 and 70 years; (2) Postoperative pathological diagnosis of HCC with BDTT requiring LT; (3) the general condition can tolerate the operation; (4) written informed consent given by the patient; (5) patients without distant metastasis.
Who cannot join
- Those who did not undergo regular LT for various reasons, split LT, reduced-size LT, simultaneous transplantation, re-transplantation, multiple-organ recipients are excluded; (2) Additional surgical procedures such as pancreaticoduodenectomy were performed; (3) those with other diseases such as active pulmonary tuberculosis, coronary heart disease, renal insufficiency and so on, which affect the therapeutic effect; (4) Extensive abdominal metastasis was found during operation; (5) serious consequences or deaths caused by anesthesia accident during operation; (6) Postoperative death due to other diseases such as traffic accidents, cardiovascular and cerebrovascular accidents; (7) With distant metastasis before operation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The prognosis for patients diagnosed with hepatocellular carcinoma with bile duct tumor thrombus (BDTT-HCC) remains notably grim, as there are presently no universally accepted treatment guidelines in place to address this complex condition. Long-term outcomes of liver transplantation (LT) for BDTT-HCC are unclear, whether LT is a proper therapeutic option for BDTT-HCC patients remains to be determined. Therefore, we designed a clinical trial to evaluate survival of BDTT-HCC patients in LT. This is an open-labeled, single-arm, prospective, multicenter and real-world study designed to assess the survival outcomes of BDTT-HCC patients in LT. Patients will be enrolled based on histological confirmation of HCC with BDTT. The study will span a total of 4 years, including a 2-year enrollment phase and a subsequent 2-year follow-up period. We anticipate that LT will provide favorable survival benefits for BDTT-HCC patients, particularly in the key indicator recurrence-free survival (RFS) and improved quality of life. Upon successful completion of the trial, we will extend our monitoring over a longer follow-up time to accurately estimate important indicators such as overall survival (OS). We expect that this study will provide substantial evidence to refine treatment guidelines through thorough data analysis, ultimately contributing to better patient outcomes and advancing our understanding of the disease.
- Medical subject headings
- Carcinoma, Hepatocellular
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 |
|---|---|---|
| HCC-BDTT in LT | HCC and BDTT patients in LT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival rate
Measured: 2025.1.10-2029.1.10
Secondary outcomes (1)
Overall survival rate
Measured: 2025.1.10-2029.1.10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start10 Apr 2025 (estimated)
- Primary completion10 Jan 2029 (estimated)
- Study completion10 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantStudies 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
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 3 Years
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
- NCT06928415
- Sponsor's protocol ID
- CT-2024-ZJU-OBS12
- Status last verified
- Jan 2025
- First submitted
- 7 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lan TC, Chen J, Yang Z, Wu SD, Lu Q, Lou CT, Hu XH, Chen YJ, Wang K, Liu P, Liu YP, Gao MW, Li JH, Xu G, Sun XY, Dou J, Guo WZ, Lv GY, Liu C, He Q, Zhu JY, Yang Y, Liu LX, Zhu ZJ, Li GM, Zhou J, Chen ZS, Lv Y, Fu ZR, Qi HZ, Ye QF, Wang ZX, Wang LM, Cai JZ, Li XC, Xia Q, Dong JH, Lu CD, Zheng SS, Yang JY, Xu X. Safety and efficacy of liver transplantation for hepatocellular carcinoma with bile duct tumor thrombus: A single-arm, multicenter, prospective study. Hepatobiliary Pancreat Dis Int. 2026 Apr;25(2):119-124. doi: 10.1016/j.hbpd.2026.01.009. Epub 2026 Feb 5.
PubMed 41714230
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Liver Transplantation for Hepatocellular Carcinoma With Bile Duct Tumor Thrombus: a Single-arm, Multicenter, Prospective Study (HCC-BDTT in LT)
- ClinicalTrials.gov ID
- NCT06928415
- Acronym / sponsor ID
- CT-2024-ZJU-OBS12
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 10 Jan 2029 (estimated)
- Study completion
- 10 Jan 2029 (estimated)
- First posted
- 15 Apr 2025 (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.
The prognosis for patients diagnosed with hepatocellular carcinoma with bile duct tumor thrombus (BDTT-HCC) remains notably grim, as there are presently no universally accepted treatment guidelines in place to address this complex condition. Long-term outcomes of liver transplantation (LT) for BDTT-HCC are unclear, whether LT is a proper therapeutic option for BDTT-HCC patients remains to be determined. Therefore, we designed a clinical trial to evaluate survival of BDTT-HCC patients in LT. This is an open-labeled, single-arm, prospective, multicenter and real-world study designed to assess the survival outcomes of BDTT-HCC patients in LT. Patients will be enrolled based on histological confirmation of HCC with BDTT. The study will span a total of 4 years, including a 2-year enrollment phase and a subsequent 2-year follow-up period. We anticipate that LT will provide favorable survival benefits for BDTT-HCC patients, particularly in the key indicator recurrence-free survival (RFS) and improved quality of life. Upon successful completion of the trial, we will extend our monitoring over a longer follow-up time to accurately estimate important indicators such as overall survival (OS). We expect that this study will provide substantial evidence to refine treatment guidelines through thorough data analysis, ultimately contributing to better patient outcomes and advancing our understanding of the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC-BDTT in LT | – | –HCC and BDTT patients in LT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCC and BDTT patients in LT
Key inclusion criteria (1 listed)
- age between 18 and 70 years; (2) Postoperative pathological diagnosis of HCC with BDTT requiring LT; (3) the general condition can tolerate the operation; (4) written informed consent given by the patient; (5) patients without distant metastasis.
Key exclusion criteria (1 listed)
- Those who did not undergo regular LT for various reasons, split LT, reduced-size LT, simultaneous transplantation, re-transplantation, multiple-organ recipients are excluded; (2) Additional surgical procedures such as pancreaticoduodenectomy were performed; (3) those with other diseases such as active pulmonary tuberculosis, coronary heart disease, renal insufficiency and so on, which affect the therapeutic effect; (4) Extensive abdominal metastasis was found during operation; (5) serious consequences or deaths caused by anesthesia accident during operation; (6) Postoperative death due to other diseases such as traffic accidents, cardiovascular and cerebrovascular accidents; (7) With distant metastasis before operation.
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
Recurrence free survival rate
Time frame: 2025.1.10-2029.1.10
1 secondary outcome
Overall survival rate
Time frame: 2025.1.10-2029.1.10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Derived from this study: PubMed 41714230Lan TC, Chen J, Yang Z, Wu SD, Lu Q, Lou CT, Hu XH, Chen YJ, Wang K, Liu P, Liu YP, Gao MW, Li JH, Xu G, Sun XY, Dou J, Guo WZ, Lv GY, Liu C, He Q, Zhu JY, Yang Y, Liu LX, Zhu ZJ, Li GM, Zhou J, Chen ZS, Lv Y, Fu ZR, Qi HZ, Ye QF, Wang ZX, Wang LM, Cai JZ, Li XC, Xia Q, Dong JH, Lu CD, Zheng SS, Yang JY, Xu X. Safety and efficacy of liver transplantation for hepatocellular carcinoma with bile duct tumor thrombus: A single-arm, multicenter, prospective study. Hepatobiliary Pancreat Dis Int. 2026 Apr;25(2):119-124. doi: 10.1016/j.hbpd.2026.01.009. Epub 2026 Feb 5.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant and Hepatocellular Carcinoma, 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 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: opening soon, as of the sponsor's last update on 15 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao xu Professor, MD. PHD (+86 13588191177, zjxu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival rate (time frame: 2025.1.10-2029.1.10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06928415, which also lists 1 linked publication.
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 15 Apr 2025.