A Randomized, Eploratory, Open Clinical Trial to Compare the Efficacy and Safety of Anlotinib Plus Irinotecan Versus Irinotecan in Patients With Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progress free survival (PFS)
研究概览
简要总结
To compare the effects and safety of Anlotinib Plus Irinotecan versus Irinotecan in patients with esophageal squamous cell carcinoma(ESCC).
详细描述
In recent years, anti-angiogenic therapy has made some progress in the treatment of advanced esophageal squamous cell carcinoma.In clinical use, the efficacy of antiangiogenic monotherapy was low, with a median progression-free survival (PFS) of only 3 to 4 months.We conducted a randomized, open clinical Trial to evaluate efficacy and safety of anlotinib hydrochloride combined with irinotecan versus irinotecan monotherapy in patients with advanced esophageal squamous cell carcinoma.
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
- None
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;
- •At least one measurable lesion (by RECIST1.1);
- •Patients who have failed to a chemoradiation treatment;
- •18-75，ECOG PS:0-1,Life expectancy of more than 12 weeks;
- •No treated with molecular targeted drugs;
- •Main organs function is normal;
- •Patients should participate in the study voluntarily and sign informed consent;
排除标准
- •Allergic to anlotinib and/or its excipients;
- •Patients with any severe and/or unable to control diseases，including：
- •Blood pressure unable to be controlled ideally(systolic pressure >140 mmHg，diastolic pressure>90 mmHg);
- •Patients with Grade 2 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥450ms for male， QT≥470ms for female) and patients with Grade 3 or higher congestive heart failure (NYHA Classification) or LVEF<50%;
- •Patients with a clear Gastrointestinal bleeding tendency include the following situations: Local active ulcer lesions, and fecal occult blood (+ +) ; The patient had a history of black and hematemesis within 2 months;
- •Patients with a bleeding tendency and INR>1.5,APTT>1.5 ULN ;
- •Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.);
- •Patients with active brain metastasis, cancerous meningitis, spinal cord compression patients or found in Screening stage;
- •Patients treated with VEGFR inhibitor;
- •Patients with drug abuse history and unable to get rid of or Patients with mental disorders;
- •Patients participated in other anticancer drug clinical trials within 4 weeks;
- •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 Plus Irinotecan
Anlotinib QD po.and Irinotecan Day 1,8 ivgtt. Both should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Anlotinib Plus Irinotecan (Drug)
Irinotecan
Irinotecan Day 1,8 ivgtt and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Irinotecan (Drug)
结局指标
主要结局
Progress free survival (PFS)
时间窗: up to 24 months
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm.
Disease Control Rate (DCR)
时间窗: up to 24 months
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR + PR + SD)
次要结局
- Overall Survival (OS)(up to 24 months)
- Objective Response Rate (ORR)(up to 24 months)
- Quality of life score(up to 24 months)
- NGS(Next Generation Sequencing) detecting(up to 12 months)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(up to 24 months)
研究者
Feng Wang
Doctor
The First Affiliated Hospital of Zhengzhou University