The Efficacy and Safety of Fruquintinib Combined With FOLFIRI/FOLFOX as Second-line Treatment in Patients With RAS-mutant Metastatic Colorectal Cancer: A Single-center, Open-label, Single-arm Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
RAS mutations are found in nearly half of colorectal cancer patients. However, there is no targeted driver gene drugs have been approved for RAS-mutated patients. For RAS mutant metastatic colorectal cancer, the commonly used treatment regimen is bevacizumab combined with chemotherapy.
详细描述
This is a single-center, open, single-arm study exploring the efficacy and safety of fruquintinib combined with FOLFIRI/FOLFOX in the treatment of RAS-mutated metastatic colorectal cancer (mCRC) who failed standard therapy. Patients will receive fruquinitinib combined with chemotherapy (FOLFOX or FOLFIRI regimens), which depend on the previous chemotherapy regimen (chemotherapy switch).
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
- •≥18 years
- •Histological or cytological confirmed colorectal cancer;
- •RAS mutation
- •Expected survival >12 weeks;
- •Fail in previous standard therapy, which must include FOLFOX/FOLFIRI;
- •ECOG PS 0-1;
- •At least one measurable lesion (according to RECIST1.1);
- •Adequate hepatic, renal, heart, and hematologic functions;
- •Negative serum pregnancy test at screening for women of childbearing potential.
排除标准
- •Received other investigational drugs within 4 weeks prior to treatment;
- •Prior treatment with anti-angiogenic small molecule targeted drugs, such as fruquintinib, etc;
- •Symptomatic brain or meningeal metastases (except for patients with BMS who have received local radiotherapy or surgery for more than 6 months and whose disease is stable);
- •Severe infection (e.g., requiring intravenous antibiotics, antifungal drugs, or antiviral drugs) within 4 weeks prior to treatment;
- •Patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
- •Patients who had active bleeding or coagulopathy within 2 months before enrollment, had a tendency to bleed, or were receiving thrombolytic therapy and were considered by the investigator to be ineligible for enrollment;
- •Active heart disease, including myocardial infarction, severe/unstable angina, 6 months prior to treatment. Echocardiography examination left ventricular ejection fraction < 50%, arrhythmia control is not good;
- •The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- •Allergy to the study drug or any of its excipients;
- •The patient is unable to take the drug orally, or the patient has a condition judged by the investigator to affect the absorption of the drug;
- •Women who are pregnant (with a positive pregnancy test before medication) or breastfeeding;
- •Urine routine showed urine protein ≥2+, and 24-hour urine protein level >1.0g;
- •Other conditions deemed by the investigator to be ineligible for inclusion in the study.
研究组 & 干预措施
Fruquintinib plus FOLFIRI/FOLFOX
Patients will receive fruquintinib plus FOLFIRI/FOLFOX. Oxaliplatin-based or irinotecan-based chemotherapy depending on previous chemotherapy (chemotherapy switch).
干预措施: Fruquintinib (Drug)
Fruquintinib plus FOLFIRI/FOLFOX
Patients will receive fruquintinib plus FOLFIRI/FOLFOX. Oxaliplatin-based or irinotecan-based chemotherapy depending on previous chemotherapy (chemotherapy switch).
干预措施: FOLFIRI (Drug)
Fruquintinib plus FOLFIRI/FOLFOX
Patients will receive fruquintinib plus FOLFIRI/FOLFOX. Oxaliplatin-based or irinotecan-based chemotherapy depending on previous chemotherapy (chemotherapy switch).
干预措施: mFOLFOX6 (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: assessed up to 1 year
time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
次要结局
- Objective response rate (ORR)(assessed up to 1 year)
- Disease Control Rate (DCR)(assessed up to 1 year)
- Overall survival (OS)(assessed up to 2 year)
研究者
Ye Xu
Professor, Chief of Department of Colorectal Surgery
Fudan University