LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)

Обзор

LIRICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable iCCA after a downstaging/disease control protocol 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-MR, especially in relation to lymph node locations, by correlating the results with histological examination after iliac 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 [Срок оценки: 3 and 5 years]

Вторичные конечные точки (11)

• OS comparison with chemotherapy alone [Срок оценки: 3 years]
• Disease-Free Survival (DFS) [Срок оценки: 3 and 5 years]
• Overall survival from the time of recurrence [Срок оценки: 5 years]
• PFS 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_RM staging (number, size, location) [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

• Histologically confirmed diagnosis of iCCA
• First diagnosis of iCCA
• Recurrence after R0 hepatic resection, N0, M0 without macrovascular invasion
• Disease considered unsuitable for hepatic resection based on tumor location and extent or underlying liver dysfunction
• Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes detected on radiological study
• No evidence of extrahepatic metastatic disease after chest-abdomen-pelvis CT and PET-MR (or PET-CT)
• At least six months have passed since the first diagnosis of iCCA (or recurrence) to the date of inclusion on the liver transplant waiting list
• The patient has received at least six months of SOC chemotherapy, achieving disease stability or partial response (according to RECIST version 1.1) at the time of listing for transplantation
• Hematochemical evaluation: Hb ≥ 9 g/dL, Leukocytes ≥ 3.0 X 109/L, Neutrophils ≥ 1.5 X 109/L, Platelets ≥ 100,000/mm3 (≥ 10 X 109/L), Total Bilirubin ≤ 3 mg/dL (≤ 51 umol/L), AST or ALT ≤ 5 times the upper limit of normal, Serum Creatinine and Urea < 1.5 times the upper limit of normal
• ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1
• Patient's BMI ≥ 18 and ≤ 30 kg/m2
• Signed informed consent, and expected patient cooperation for treatment and follow-up, must be obtained and documented according to good clinical practice and national/local regulations

Критерии исключения

• Tumor involving nearby extrahepatic structures (including involvement of major hepatic vessels) by direct invasion (T4 per AJCC 8th edition)
• Tumor penetrating the visceral peritoneum (T3 per AJCC 8th edition)
• Previous extrahepatic metastatic disease
• Prior neoplasms, except those treated curatively for more than 5 years without recurrence
• Known history of human immunodeficiency virus (HIV) infection
• Known history of solid organ or bone marrow transplantation
• Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study or with the evaluation of study outcomes
• Pregnant or breastfeeding women
• Medical-surgical contraindications for liver transplantation
• Any reason for which, in the investigator's judgment, the patient should not participate in the study

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

Публикации

• Blair AB, Alobuia WM, Palta M, Raman SS, Levine MH, Benson AB 3rd, D'Angelica MI, Cloyd JM. Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma. J Natl Compr Canc Netw. 2025 Aug 14;23(9):e257085. doi: 10.6004/jnccn.2025.7085. PMID 40812353

Идентификаторы

NCT: NCT06098547 · AOP 3006 · LIRICA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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