NCT05818982招募中2 期
A Multicenter, Open-label, Randomized, Controlled Phase II Study to Evaluate the Efficacy and Safety of Afatinib Versus Irinotecan as a Second-line and Above Treatment for Advanced ALTRK-negative ESCC
Peking University3 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年2月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Progression-free survival
研究概览
简要总结
This is a phase II study to evaluate the effectiveness and safety of Afininib compared to irinotecan in the 3-gene RNA sequencing (ALTRK) negative advanced esophageal squamous squamous carcinoma.
详细描述
Participants were assigned to either group A or group B at 2:1 randomization (block randomization). Group A received afatinib (40 mg orally/day) every 6 weeks; Group B received irinotecan (140-180mg/m2 intravenous) every 2 weeks.
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
- •Agree to participate and sign the informed consent form in writing;
- •Age: 18-75 years old;
- •No gender limit;
- •Esophageal squamous cell carcinoma diagnosed by pathology;
- •The results of 3-gene RNA sequencing (ALTRK) in tumor tissue were negative;
- •Imagingly confirmed unresectable advanced esophageal squamous cell carcinoma;
- •Failure of previous platinum-containing regimens and immunotherapy regimens (PD-1/PD-L1 monoclonal antibody);
- •At least one measurable lesion (according to RECIST1.1 criteria) or non-measurable lesion that can be evaluated, with imaging diagnosis ≤ 21 days from enrollment;
- •Estimated survival≥ 3 months;
- •General Physical Condition (ECOG) 0-1;
- •Sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥ 9 g/dL, white blood cell ≥ 3.0×10^9/L, neutrophil ≥1.5×10^9/L, platelet ≥ 100×10^9/L; Normal liver and kidney function (within 14 days): TBIL ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 2.5 times the upper limit of normal, and if liver metastases are present, ≤ 5 times the upper limit of normal; Creatinine ≤ 1.5 times the upper limit of normal;
排除标准
- •Those who are currently receiving other effective programs;
- •Patients who have participated in other clinical trials within 4 weeks before enrollment;
- •There is no measurable tumor foci, such as fluid accumulation in the body cavity or diffuse infiltration of organs;
- •Those who have received radiotherapy for measurable lesions;
- •Previous anti-EGFR monoclonal antibody or EGFR-TKI treatment;
- •Patients with other primary malignant tumors other than esophageal cancer at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
- •Clinically significant cardiovascular diseases, such as heart failure (NYHA GRADE III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or history of myocardial infarction within the past 1 year;
- •Neurological or psychiatric abnormalities affecting cognitive ability, including central nervous system metastases;
- •Active severe clinical infection (grade >2 NCI-CTCAE version 5.0) within 14 days prior to enrollment, including active TB;
- •Known or reported HIV infection or active hepatitis B or C;
- •Uncontrolled systemic diseases, such as poorly controlled diabetes;
- •History of interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest x-ray/CT;
- •Keratitis, ulcerative keratitis or severe dry eye;
- •Known hypersensitivity or anaphylaxis to any component of the investigational drug;
- •Pregnancy (determined by serum β-chorionic gonadotropin test) or breastfeeding;
- •The investigator determines that there are abnormal heart or lung or kidney or liver function that is not suitable for the treatment of this study;
研究组 & 干预措施
Cohort A
Experimental
Group A received afatinib (40 mg oral/day) every 6 weeks
干预措施: Afatinib (Drug)
Cohort B
Active Comparator
Group B received irinotecan (140-180mg/m2 intravenous) every 2 weeks
干预措施: Irinotecan (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 2 years
PFS is defined as the time from the first dose to the date of the disease progression or death from any cause.
次要结局
- Objective response rate(2 years)
- Disease control rate(2 years)
- Overall survival(2 years)
- Adverse Events(2 years)
研究者
Shen Lin
Professor
Peking University
研究点 (3)
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