LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)

Обзор

LITALHICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable perihilar cholangiocarcinoma (pCCA) after treatment with standard of care chemotherapy, in terms of overall survival and quality of life. Additionally, the study aims to identify pre-transplant biological markers and clinical factors that can stratify patients with the best post-transplant prognosis. Finally, the study aims to investigate the role of preoperative PET-MRI, especially in relation to lymph node locations, by correlating the results with histological examination after hilar lymphadenectomy.

Вмешательства

• Процедура Liver transplantation
  Patients will undergo liver transplantation according to the standard procedures of the institutional Center's protocol (cadaveric or living donor transplantation, whole or partial liver). Liver transplantation is preceded by an exploratory laparotomy with clinical evaluation and frozen section examination of lymph nodes in the hepatoduodenal ligament and along the common hepatic artery/celiac axis.

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: 3 and 5 years]

Вторичные конечные точки (11)

• Overall survival comparison with chemotherapy alone [Срок оценки: 3 years]
• Progression-Free Survival (PFS) [Срок оценки: 3 and 5 years]
• Overall survival from the time of recurrence [Срок оценки: 5 years]
• Progression-free survival comparison with chemotherapy alone [Срок оценки: 3 years]
• Biological markers [Срок оценки: 5 years]
• Morbidity [Срок оценки: 90 days]
• Cancer-related mortality [Срок оценки: 3 and 5 years]
• Drop out [Срок оценки: 5 years]
• Concordance of surgical and PET/MRI staging [Срок оценки: Perioperative]
• Quality of life assessed using EORTC QLQ-C30 [Срок оценки: 5 years]
• Quality of life assessed using FACT-Hep questionnaire [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Diagnosis of pCCA (transcatheter biopsy or brush cytology, CA 19-9 > 100 mg/mL and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography, or biliary ploidy with a malignant appearing stricture on cholangiography)
• Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic involvement of CBD) or resectable pCCA arising in PSC
• Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes
• No extrahepatic metastatic disease
• Radial tumor diameter ≤3 cm
• At least six months between first diagnosis of pCCA and date of inclusion
• At least six months of SOC chemotherapy, achieving disease stability or partial response

Критерии исключения

• Uncontrollable infection
• Prior radiotherapy or chemotherapy
• Prior biliary surgical resection or attempted surgical resection
• Diameter of tumor >3cm
• Presence of intra-hepatic metastases or iCCA
• Present or past evidence of extrahepatic metastatic disease
• Transperitoneal biopsy (including percutaneous ecography-guided FNA)
• Prior neoplasms, except those treated curatively for more than 5 years without recurrence
• Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study
• Pregnant or breastfeeding women
• Medical-surgical contraindications for liver transplantation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Azienda Ospedale Università di Padova — Padova

Идентификаторы

NCT: NCT06125769 · AOP 3007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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