Living donor liver transplant in advanced hepatocellular carcinoma (HCC) down staged with systemic therapy with or without locoregional therapy (LRT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 9
- 主要终点
- 1.Overall survival at 1 year post transplant and end of study- Transplant Benefit (comparison between the 4 groups)
研究概览
简要总结
Study rationale- BCLC C hepatocellular carcinoma (HCC) downstaged with locoregional therapy (LRT) has acceptable 5 year post transplant survival. We propose to study the effect of systemic therapy with/without locoregional therapy for downstaging HCC and to see post transplant outcomes like overall survival, recurrence, surgical complications and rejection. Case series are available for the same where patients downstaged with systemic therapy have been successfully transplantedbut there is no large prospective multicentric data.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •HCC downstaged with systemic therapy with or without locoregional therapy to within UCSF criteria.
排除标准
- •Extrahepatic metastasis
- •Poor performance status.
结局指标
主要结局
1.Overall survival at 1 year post transplant and end of study- Transplant Benefit (comparison between the 4 groups)
时间窗: 3 years
2. Recurrence free survival at 1 year post transplant and end of study (Group 1, 4)
时间窗: 3 years
3. Recurrence rate at 1 year post transplant and end of study (Group 1, 4)
时间窗: 3 years
次要结局
- 1. Rejection rate over 1 year (Group 1, 4)(2. Surgery related complications – bleeding, wound healing, biliary complications, infections (Group 1, 4))
研究者
Dr Alisha Chaubal
Nanavati Max Super Speciality Hospital