An observational study in Liver Transplant, Hepatocellular Carcinoma and Bile Duct Tumor Thrombus, sponsored by Zhejiang University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by Zhejiang University · Observational
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 130 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.
Counted across the registry records on this site, refreshed daily.
HCC and BDTT patients in LT
(1) 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.
Exclusion Criteria:
(1) 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.
HCC and BDTT patients in LT
Recurrence free survival rate
Time frame: 2025.1.10-2029.1.10
Overall survival rate
Time frame: 2025.1.10-2029.1.10
Tumor recurrence rate
Time frame: 2025.1.10-2029.1.10
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zhejiang University