NCT06098547招募中不适用
LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)
Azienda Sanitaria Ospedaliera2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Overall Survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Overall Survival
时间窗: 3 and 5 years
Survival from time of transplantation to time of death or last follow up
次要结局
- PFS comparison with chemotherapy alone(3 years)
- OS comparison with chemotherapy alone(3 years)
- Disease-Free Survival (DFS)(3 and 5 years)
- Concordance of surgical and PET_RM staging (number, size, location)(Perioperative)
- Quality of life assessed using EORTC QLQ-C30(5 years)
- Biological markers(5 years)
- Overall survival from the time of recurrence(5 years)
- Cancer-related mortality(3 and 5 years)
- Morbidity(90 days)
- Drop out(5 years)
- Quality of life assessed using FACT-Hep questionnaire(5 years)
研究者
Enrico Gringeri
Associate Professor
Azienda Ospedaliera di Padova
研究点 (2)
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