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

Обзор

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.

Первичные конечные точки

• Recurrence free survival rate [Срок оценки: 2025.1.10-2029.1.10]

Вторичные конечные точки (1)

• Overall survival rate [Срок оценки: 2025.1.10-2029.1.10]

Критерии участия

Критерии включения

(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.

Критерии исключения

(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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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 PMID 41714230

Идентификаторы

NCT: NCT06928415 · CT-2024-ZJU-OBS12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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