Treatment Patterns and Clinical Outcomes Among Patients Receiving Anlotinib in Combination With PD-1 Inhibitor for Advanced/Metastatic Esophageal Squamous Cell Carcinoma in Real-world Settings(APEC)
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Efficacy and Safety of Anlotinib combined with PD-1 inhibitors as 2 or more lines treatment for Heavily Pretreated Patients With Advanced, Metastatic Squamous Cell Carcinoma of the Esophagus.
详细描述
The APEC study is a multi-center, retrospective ,real-world study of anlotinib combined with PD-1 inhibitors for patients with histologically confirmed advanced and metastatic esophageal squamous cell carcinoma (ESCC) that progressed after 1or more lines of therapy, conducted at 8 sites in China. Patients received anlotinib combined with PD-1 inhibitors , every 3 weeks for up to 2 years, until progression of disease, unacceptable toxic effects occurred, or withdrawal of consent. The primary end point was the progression-free survival (PFS)among all patients. Secondary end points included Adverse events (AEs),objective response rate (ORR) ,duration of response (DOR), , and overall survival (OS). Tumor response was assessed per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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 patients aged more than 18 years old;
- •ECOG PS：0-2;
- •Subjects with histologically or cytologically confirmed locally advanced and/or advanced esophageal squamous cell carcinoma(ESCC);
- •For local advanced or advanced ESCC, disease progression occurred after 1 or more lines systemic treatment previously;
- •Have received anlotinib combined with PD-1 inhibitor treatment.
排除标准
- •have used Anlotinib before;
- •mixed with small cell cancer and/or other kinds of cancer ;
- •Previously (within 5 years) or presently suffering from other malignancies;
- •Symptomatic or uncontrolled brain metastases;
- •Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months or serious cardiac arrhythmia requiring medication;
- •Pregnancy or lactation. -
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 6 months
PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause
次要结局
- Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD (up to 12 months))
- Overall Survival (OS)(12 months)
- Adverse Events(Until 30 day safety follow-up visit)
研究者
Jun Liu
associate proffessor
Shanghai Chest Hospital