JPRN-jRCT1070220052招募中1 期
iving donor liver transplantation for unresectable perihilar cholangiocarcinoma
Hibi Taizo0 个研究点目标入组 20 人开始时间: 2022年9月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 15age old 至 < 70age old（—）
- 性别
- All
入选标准
- •1. Unresectable disease but with no extrahepatic metastases and remains progression-free for 3 months or more under neoadjuvant Tx
- •i. Poor hepatic reserve (future liver remnant less than 40%, ICG-R15 10% or more, or ICG-K less than 0.05)
- •ii. Inability to resume portal vein/arterial inflow due to extensive vascular invasion
- •iii. Extensive longitudinal spread along the biliary tree precluding R0 resection
- •iv. Cholangiocarcinoma arising in the setting of PSC with poorly-defined localization
- •2. Conditions fit for living donor liver transplantation
- •a)Age, 15-69
- •b)ECOG performance status, 0 or 1
- •c)Laboratory data that meet the following:
- •i.Neutrophil: 1,500/microliter or more
- •ii.Platelet: 30,000/microliter or more
- •iii.Hb: 7.5g/dL or more
- •iv.Cr: 1.5mg/dL or more
- •v.New York Heart Association (NYHA) classes I and II
- •vi.Hugh-Jones classes I and II
- •d)Documented informed consent from the participant
排除标准
- •1. Presence of intra and extrahepatic metastases
- •2. Presence of Lymph node metastases
- •3. Malignancies other than perihilar cholangiocarcinoma
- •4. Presence of uncontrolled infection
- •5. Adverse events Grade 4 or more (CTCAE v5.0) due to neoadjuvant therapy
- •6. Other conditions that are clinically unfit for the study
研究者
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