LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
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.
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
- •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
排除标准
- •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
研究组 & 干预措施
Study population
Candidates will be evaluated by a National Multidisciplinary Group after routine radiological studies (CT, MRI, PET-MRI/CT).
Patients will receive 6 months of standard of care chemotherapy and undergo PET-MRI with FDG to exclude the presence of extrahepatic disease.
Following completion of therapy, patients will undergo radiological restaging: those who demonstrate stable disease at this stage are considered eligible for definitive listing for LT. Patients will continue chemotherapy until a compatible liver becomes available. If there are no further contraindications, exploratory laparotomy and surgical nodal staging of the tumor will be performed at the time of transplantation. If there are no signs of extrahepatic disease, transplantation will be conducted according to institutional protocols.
干预措施: Liver transplantation (Procedure)
结局指标
主要结局
Overall Survival (OS)
时间窗: 3 and 5 years
Survival from time of transplantation to time of death or last follow up
次要结局
- Overall survival comparison with chemotherapy alone(3 years)
- Morbidity(90 days)
- Concordance of surgical and PET/MRI staging(Perioperative)
- Progression-Free Survival (PFS)(3 and 5 years)
- Overall survival from the time of recurrence(5 years)
- Biological markers(5 years)
- Cancer-related mortality(3 and 5 years)
- Drop out(5 years)
- Quality of life assessed using EORTC QLQ-C30(5 years)
- Progression-free survival comparison with chemotherapy alone(3 years)
- Quality of life assessed using FACT-Hep questionnaire(5 years)
研究者
Enrico Gringeri
Associate Professor
Azienda Sanitaria Ospedaliera