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NCT06928415Not yet recruiting

Efficacy and Safety of Liver Transplantation for Hepatocellular Carcinoma With Bile Duct Tumor Thrombus: a Single-arm, Multicenter, Prospective Study (HCC-BDTT in LT)

Source: ClinicalTrials.gov · Last updated 15 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
130 (estimated)
First submitted
7 Apr 2025
Start date
10 Apr 2025
Primary completion date
10 Jan 2029
Lead sponsor
Zhejiang University
NCT number
NCT06928415

What you commit to

  • Study type: Observational
  • Planned participants: 130
  • From 10 Apr 2025 to the primary completion date, 10 Jan 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • (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.

Who the study is looking for

  • (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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.