A Randomized, Double-blind and Placebo-controlled Phase III Trial Comparing Fruquintinib Efficacy and Safety vs Best Support Care (BSC) in Advanced Colorectal Cancer Patients Who Have Failed at Least Second Lines of Chemotherapies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 416
- 试验地点
- 3
- 主要终点
- overall survival
研究概览
简要总结
Fruquintinib administered at 5mg once daily(QD) in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with metastatic colorectal cancer (CRC) in phase Ib and phase 2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after second line or above standard chemotherapy
详细描述
This is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial to compare the efficacy and safety of Fruquintinib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer who have progressed after second-line or above standard chemotherapy. After checking eligibility criteria, subjects will be randomized into Fruquintinib plus BSC group (treatment group) or placebo plus BSC group (control group) in a ration of 2:1. Primary Efficacy Endpoint: Overall Survival (OS). Secondary Efficacy Endpoints: Progression free survival (PFS) (According to RECIST Version 1.1), Objective Response Rate (ORR), Disease Control Rate (DCR), . Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •≥ 18 and ≤ 75 years of age , with ≥ 40Kg
- •Histological or cytological confirmed colorectal cancer
- •ECOG performance status of 0-1
- •Standard regimen failed or no standard regimen available
- •Adequate hepatic, renal, heart, and hematologic functions
- •At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
- •Signed and dated informed consent
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure
排除标准
- •- Pregnant or lactating women
- •Any factors that influence the usage of oral administration
- •Evidence of CNS metastasis
- •Intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
- •Abuse of alcohol or drugs
- •Less than 4 weeks from the last clinical trial - Previous treatment with VEGFR inhibition
- •Disability of serious uncontrolled intercurrence infection
- •Proteinuria ≥ 2+ (1.0g/24hr)
- •Have evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness
- •Within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.
- •Within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or CABG
- •Bone fracture or wounds that was not cured for a long time
- •Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy
研究组 & 干预措施
treatment arm
treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.
干预措施: fruquintinib (Drug)
control arm
control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.
干预措施: placebo (Drug)
结局指标
主要结局
overall survival
时间窗: from randomization until death due to any cause, assessed up to 2 year
every two months after end of treatment (EOT) observation period at 30 days after the last medication
次要结局
- progression free survival(from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year)
- Objective Response Rate (ORR)(from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year)
- Disease Control Rate (DCR)(from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year)
- Safety and tolerance evaluated by incidence, severity and outcomes of AEs(from first dose to within 30 days after the last dose)