A Phase III Study to Evaluate the Efficacy and Safety of Fruquintinib in Combination With Paclitaxel Versus Paclitaxel Alone in Second Line Gastric Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 703
- 试验地点
- 8
- 主要终点
- Overall survival (OS)
研究概览
简要总结
Fruquintinib once daily in 4 weeks treatment cycle (three weeks on and one week off) in combination with Paclitaxel 80mg/㎡（day1, 8, 15 of 4 weeks cycle) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced GC in ph1b/2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in combination with Paclitaxel in the treatment of patients with aGC who have progressed after first line 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 combined with Paclitaxel versus Paclitaxel alone in patients with advanced gastric cancer who have progressed after first-line standard chemotherapy. After checking eligibility criteria, subjects will be randomized into Fruquintinib combined with Paclitaxel group (treatment group) or placebo combined with Paclitaxel group (control group) in a ratio of 1:1. Primary Efficacy Endpoint: Overall Survival (OS), Progression free survival (PFS) (According to RECIST Version 1.1). Secondary Efficacy Endpoints: Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DOR), EORTC QLQ-C30 (V3) .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 4.03.
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
- •Signed informed consent
- •Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
- •Metastatic disease or locally advanced, unresectable disease
- •Disease progression during or within 4 months after the last dose of the first-line therapy (with platinum/fluoropyrimidine )
- •Adequate hepatic, renal, heart, and hematologic functions
- •At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure
- •Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1
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 randomization, 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
- •The tumor invades a large vessel structure, such as the pulmonary artery, superior vena cava, or inferior vena cava
结局指标
主要结局
Overall survival (OS)
时间窗: from randomization until death due to any cause, assessed up to 3 year
every two months follow up after EOT observation period at 30 days after the last medication
Progression free survival (PFS)
时间窗: from the date of randomization to the date of the first documented progressive disease or date of death due to any cause, assessed up to 1 year]
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.
次要结局
- The European Organization for Reasearch and Treatment of Cancer（EORTC ） Quality of Life Questionnaire-Core 30 V3.0 (QLQ-C30 v3.0)(Evaluation before the beginning of each treatment cycle, at the end of treatment, and at the 30 days post the last dose，up to 2 years)
- Objective response rate (ORR)(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 30 days post the last dose)
- Disease control rate (DCR)(from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year)
- Duration of response, DOR(: From the first documented PR or CR until the first documented PD or death，assessed up to 2 years)