NCT02649361已完成2 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Esophageal Squamous Cell Carcinoma(ALTER1102)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 18
- 主要终点
- Progress free survival (PFS)
研究概览
简要总结
To compare the effects and safety of Anlotinib with placebo in patients with esophageal squamous cell carcinoma(ESCC).
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
- •Histological documentation of esophageal squamous cell carcinoma；
- •Advanced esophageal squamous cell carcinoma with distant metastasis(Stage IV),at least one measurable lesion (by RECIST1.1)
- •Patients who at least have failed to a platinum-based chemotherapy treatment or chemotherapy containing paclitaxel.
- •Note: (1) Each line treatment refers to treatment duration at least one cycle using monotherapy or drug combination; (2)Adjuvant chemotherapy or neoadjuvant chemoradiation is permitted before the study (if disease recurred during adjuvant chemotherapy/neoadjuvant chemoradiation or recurred within 6 months after stopping treatment, adjuvant chemotherapy/neoadjuvant chemoradiation can be considered as first line systemic chemotherapy;
- •18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months
- •4 weeks or more from the last cytotoxic therapy, radiation therapy or surgery
- •Main organs function is normal
- •Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
- •Patients should participate in the study voluntarily and sign informed consent
排除标准
- •Patients whose primary lesion with active bleeding within 2 months
- •Primary lesion not resected and has not shrinked after radiation therapy
- •Patients who have been failure with anti-tumor angiogenesis drug treatment
- •Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
- •Brain metastases patients with symptoms or symptoms controlled < 3 months
- •Patients with any severe and/or unable to control diseases，including：
- •Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
- •Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
- •Patients with active or unable to control serious infections;
- •Patients with cirrhosis, decompensated liver disease, or active hepatitis;
- •Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
- •Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed
- •Patients with non-healing wounds or fractures
- •Patients with any CTC AE Grade 1 or higher bleeding events occurred in the lungs or any CTC AE Grade 2 or higher bleeding events occurred within 4 weeks prior to assignment;Patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation
- •Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism
- •Patients with drug abuse history and unable to get rid of or Patients with mental disorders
- •Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage
- •Patients participated in other anticancer drug clinical trials within 4 weeks
- •History of immunodeficiency
- •Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
研究组 & 干预措施
Anlotinib
Experimental
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Anlotinib (Drug)
Placebo
Placebo Comparator
Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Placebo (Drug)
结局指标
主要结局
Progress free survival (PFS)
时间窗: From randomization，each 42 days up to PD or death(up to 24 months)
次要结局
- Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- Overall Survival (OS)(From randomization until death (up to 24 months))
- Disease Control Rate (DCR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
研究者
研究点 (18)
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