Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Perihilar Cholangiocarcinoma. A Prospective Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Overall survival at 1, 3, and 5 years post-transplant
研究概览
简要总结
A prospective multicentre study which includes patients ≤ 70 years-old diagnosed of unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases. Liver transplantation preceded by neoadjuvant radiochemotherapy will be performed in this selected group.
The primary endpoint will be overall survival at 1, 3, and 5 years post-transplant. The secondary endpoints will be: 1) recurrence-free survival at 1, 3 and 5 years post-transplant; 2) intention-to-treat survival of all patients included in the study at 1,3 and 5 years; 3) the rate of patients included in the study who are finally transplanted.
详细描述
A prospective multicentre pilot study which includes patients ≤ 70 years-old diagnosed of unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases.
The number of subjects necessary is 34 patients to achieve a power of 82% with a significance level of 0.05 to detect a 40% difference between the estimated 50% survival of those patients who are transplanted and 10% of those patients with hCCA unresectable who are not transplanted. This corresponds to a hazard ratio of 3.3219. Estimated loss to follow-up of 10% of patients.
RADIOLOGICAL EVALUATION
It will be considered unresectable those lesions Bismuth IV with the following criteria (Jarnagin WR, et al. Ann Surg 2001; 234:507; Memorial Sloan Kettering Cancer Center Hilar Cholangiocarcinoma Classification):
- Bilateral extension to second order biliary
- Unilateral extension to second-order biliary radicals AND contralateral portal vein involvement OR contralateral hepatic lobar atrophy
- Main or bilateral portal vein involvement
- Insufficient future liver remnant even after portal embolization
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Willing and able to provide written consent form
- •Age ≤ 70 years-old
- •ECOG 0 or 1
- •Unresectable hCCA ≤3cm in radial diameter
排除标准
- •Those patients who have received chemotherapy or radiotherapy previously out of protocol
- •Liver, extrahepatic or lymph node metastases
- •Previous intent of surgical resection or percutaneous biopsy
- •Previous or concurrent cancer that is different in primary site or histology from adenocarcinoma, except cervical carcinoma in situ, localized prostate cancer, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, T1). Any cancer curatively treated 5 years prior to entry is permitted.
- •Infection no controlled
研究组 & 干预措施
Study group
Patients with unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases
干预措施: Neoadjuvant Chemo-radiotherapy (Drug)
Study group
Patients with unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases
干预措施: Liver Transplantation (Procedure)
结局指标
主要结局
Overall survival at 1, 3, and 5 years post-transplant
时间窗: 5 years
次要结局
- Recurrence free survival at 1, 3 and 5 years post-transplant(5 years)
- Intention-to-treat survival of overall patients included in the study at 1,3 and 5 year(5 years)
- The rate of patients included in the study who are finally transplanted.(5 years)
研究者
Cristina Dopazo Taboada
Consultant Surgeon
Hospital Vall d'Hebron