NCT03803436招募中2 期
Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation: a Prospective Parallel Trial
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano12 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年1月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 12
- 主要终点
- Overall Survival
研究概览
简要总结
The COLT trial is an investigator-driven, multicenter, non-randomized, open-label, controlled, prospective, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in liver-only CRC metastases, compared with a matched cohort of patients bearing the same tumor characteristics, collected during the same time period and included in a phase III Italian RCT on triplet chemotherapy+antiEGFR
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-mucinous colon adenocarcinoma.
- •Primary tumor as pT1-3, pN0 or pN1 (metastases in < 4 regional lymph nodes), confirmed R0 resection.
- •RAS and BRAF wild-type & MSS molecular status as per local testing.
- •Liver metastases not eligible for curative liver resection
- •Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (CR+PR+SD) during second-line treatment for at least 4 months.
- •A maximum of two prior chemotherapy treatment lines.
- •Performance status, ECOG
- •Satisfactory blood tests Hb >10g/dl, neutrophils >1.0 (after any G-CSF), TRC >75, Bilirubin<2 x upper normal level, AST, ALT<5 x upper normal level, creatinine <1.25 x upper normal level.
- •CEA<50 ng/ml
排除标准
- •Hereditary CRC syndromes including FAP and Lynch syndrome.
- •Prior extra hepatic metastatic disease or primary tumor local relapse.
- •Extra-peritoneal cancers (rectum).
- •Other malignancies in the previous 5 years
- •Active intra-venous or alcohol abusers
- •HIV infection
研究组 & 干预措施
Study arm
Experimental
Liver transplant
干预措施: Liver transplant (Procedure)
Parallel arm
Active Comparator
Chemotherapy
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Overall Survival
时间窗: 5 years
Time from enrolement to either death or censoring
次要结局
- Complications rate(90 days after liver transplant)
- Progression Free Survival(5 years)
研究者
研究点 (12)
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