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临床试验/NCT07263178
NCT07263178招募中不适用

A Multi-center, Prospective, Observational Study to Assess the Treatment Patterns and Prognosis of Second and Later-line Palliative Chemotherapy in Patients With Metastatic Colorectal Cancer Who Failed First-line Palliative Chemotherapy

Boryung Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年11月7日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Progression-free survival (PFS)

研究概览

简要总结

This study aims to comprehensively identify the various treatment patterns of second- or subsequent-line palliative chemotherapy used in patients with metastatic colorectal cancer who have experienced failure of first-line palliative chemotherapy and to evaluate the prognosis of each treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have signed the informed consent after receiving information about the purpose and method of this study.
  • Patients with histologically and radiologically confirmed metastatic colorectal cancer (colorectal cancer) who have evaluable (measurable) lesions.
  • Patients scheduled to receive their first second-line palliative chemotherapy following failure of first-line palliative chemotherapy (including those who relapse during or within 6 months after completion of postoperative adjuvant therapy, necessitating palliative chemotherapy).
  • Patients who understand the research, are cooperative in the research process, and are deemed capable of participating until the completion date.

排除标准

  • Female patients who are pregnant, have childbearing potential, or are breastfeeding.
  • Has received an investigational product within 4 weeks from the study enrollment or has plans to participate in another clinical trial during the participation of this study.
  • Other subjects who are considered inappropriate to participate in this study by the judgment of the investigator.

结局指标

主要结局

Progression-free survival (PFS)

时间窗: up to 24 months

Progression-free survival (PFS) by treatment pattern

次要结局

  • Objective Response Rate (ORR)(up to 24 months)
  • Types of Third palliative chemotherapy(up to 24 months)
  • Conversion rate(up to 24 months)
  • Quality of Life Assessment(up to 12 months)
  • Overall Survival (OS)(up to 24 months)
  • Dosage period for each treatment pattern(up to 24 months)
  • Types of Secondary palliative chemotherapy(up to 24 months)
  • Eastern Cooperative Oncology Group Performance Status(ECOG PS) Assessment(up to 24 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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