EUCTR2018-001600-12-IT进行中（未招募）1 期
Phase II randomized study evaluating the efficacy of panitumumab (VEctibix) and Trifluridine-Tipiracil (LOnsurf) in pretreated RAS wild type metastatic colorectal cancer patients: the VELO trial - VELO
Dipartimento di Medicina di Precisione - Università degli studi della Campania L. Vanvitelli0 个研究点目标入组 112 人开始时间: 2021年5月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically proven diagnosis of colorectal adenocarcinoma
- •Diagnosis of metastatic disease
- •RAS (NRAS and KRAS exon 2,3 and 4) wild-type in tissue at initial
- •Efficacy of a first line therapy containing an anti-EGFR agent
- •(panitumumab or cetuximab) with a major response achieved (complete
- •or partial response)
- •A second line therapy
- •More than 4 months from last dose of anti-EGFR agent administered
- •in first line treatment before randomization.
- •ECOG Performance Status 0-1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 66
排除标准
- •Any contraindication to use Trifluridine - Tipiracile or Panitumumab
- •Active uncontrolled infections
- •Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
- •Pregnancy
- •Breastfeeding
- •Interstitial lung disease or pulmonary fibrosis
- •Grade III or IV heart failure (NYHA classification)
研究者
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