跳至主要内容
临床试验/JPRN-jRCT2051210165
JPRN-jRCT2051210165招募中1 期

A double-blind, placebo-controlled, randomized, dose-escalating, multicenter, Phase 1 study to assess the safety and tolerability of ART-123 in combination with leucovorin/5-fluorouracil/oxaliplatin and bevacizumab in metastatic colorectal cancer patients

Tawara Shunsuke0 个研究点目标入组 80 人开始时间: 2022年2月1日最近更新:

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
80

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
>= 18age old 至 ot applicable(—)
性别
All

入选标准

  • *18 years of age or older
  • * Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
  • * ECOG performance status of 0 or 1
  • * The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges Willingness of the patient and the sexual partner to use a highly effective
  • contraceptive method during the course of the study
  • * Able to sufficiently understand the clinical study and give written informed consent

排除标准

  • *History of major hemorrhage
  • * High risk of hemorrhage
  • * History of other malignancies
  • * Active ulcer
  • * Patients using anti-coagulants and fibrinolytic drugs
  • * Active Hepatitis B, or known HBs antigen positive
  • * Prior treatment history with thrombomodulin alfa
  • * Administration of another investigational medicinal product within 30 days prior to randomization
  • * Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period
  • * Patients otherwise deemed as inappropriate to participate in the study by the Investigator

研究者

发起方
Tawara Shunsuke

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