NCT05797883招募中2 期
Clinical Study on the Efficacy and Safety of FOLFOX/FOLFIRI± Targeted Drug Regimen Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
To observe and evaluate the efficacy and safety of FOLFOX/FOLFIRI± target-directed regimen containing Levofolinic Acid (Zuoyu ®) in first-line treatment of unresectable or metastatic colorectal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ≥18 years old;
- •Patients with histopathologically confirmed unresectable or metastatic colorectal cancer who have not previously received chemotherapy or targeted therapy for unresectable or metastatic lesions;
- •Have at least one measurable lesion according to RECIST 1.1 standards;
- •ECOG PS score: 0-2;
- •Expected survival greater than 3 months;
- •Routine blood routine, liver and kidney function, electrocardiogram and other routine tests were basically normal, no contraindications of chemotherapy;
- •The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up visits;
- •Researchers believe treatment can benefit.
排除标准
- •A proven allergy to the test drug and/or its excipients;
- •Pregnant or lactating women;
- •Patients judged by the investigator to be unsuitable for inclusion in this study;
研究组 & 干预措施
FOLFOX/FOLFIRI
Experimental
q2w, after 8 cycles of medication or patient intolerance or disease progression;
干预措施: FOLFOX/FOLFIRI (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 2 years
The proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by iRECIST v1.1
次要结局
- Progression-free survival (PFS)(2years)
- Disease control rate (DCR)(2years)
研究者
Jingdong Zhang
Chief physician
China Medical University, China
研究点 (1)
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