A Study to Evaluate the Efficacy and Safety of a First-line Treatment for Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 583
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Phase II study of simultaneous infusion of levozolinate for injection and 5-FU as first-line treatment for advanced colorectal cancer
详细描述
To observe and evaluate the efficacy and safety of simultaneous infusion of levofolinate for injection and 5-FU in the first-line treatment of advanced colorectal cancer
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects voluntarily joined this study and signed the informed consent form.
- •Age: 18 to 75 years old, gender not limited;
- •ECOG PS score: 0-2 points
- •Patients with unresectable or metastatic colorectal cancer confirmed by histology or cytology, where the primary tumor location and the status of RAS and BRAF are known;
- •No previous treatment for unresectable or metastatic lesions has been received;
- •There is at least one measurable lesion in accordance with the RECIST 1.1 standard;
- •In the pre-treatment examination indicators, there was no serious hematopoietic function abnormality, and the functions of the heart, lungs, liver and kidneys were basically normal.
- •Hemoglobin (Hb) ≥70 g/L;
- •White blood cell count (WBC) ≥3.0×109/L; Neutrophil count (NEUT) ≥1.5×109/L;
- •Platelet count (PLT) ≥100×109/L;
- •Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level ≤2.5 times the upper limit of normal value (ULN); Renal function (serum creatinine sCr) level ≤1.5 times the upper limit of the normal value (ULN). Total bilirubin (TBIL) ≤1.5 times the upper limit of the normal value (ULN).
- •The expected survival period is more than three months.
排除标准
- •Those who have been confirmed to be allergic to the test drug and/or its excipients;
- •Those with contraindications to chemotherapy;
- •Colorectal cancer patients with MSI-H or dMMR;
- •Pregnant or lactating women;
- •There is a history of other malignant tumors in the past;
- •Those with systemic internal diseases and mental disorders who are not suitable for chemotherapy;
- •Patients who were determined by the researchers to be unsuitable for inclusion in this study.
研究组 & 干预措施
arm1
For patients with wild-type RAS and BRAF and the primary lesion located in the left colorectum, the mFOLFOX6 or FOLFIRI regimens with simultaneous infusion of levofolinic acid and 5-FU for injection were received. Whether to combine cetuximab was determined by the researchers
干预措施: mFOLFOX/FOLFIRI ( Standard Chemotherapy) (Drug)
arm2
For patients with both RAS and BRAF wild-type and with the primary lesion located in the right colorectal and/or RAS or BRAF mutant type, the mFOLFOX6 or FOLFIRI regimen with simultaneous infusion of levofolinic acid and 5-FU for injection, whether to combine bevacizumab, was determined by the researchers
干预措施: mFOLFOX/FOLFIRI ( Standard Chemotherapy) (Drug)
结局指标
主要结局
PFS
时间窗: up to 3 years
次要结局
- ORR(up to 3 years)
- OS(up to 3 years)
- DCR(up to 3 years)
- DoR(up to 3 years)
- Adverse Event(Thirty days after the last treatment)
研究者
Dai, Guanghai
Professor
Chinese PLA General Hospital