PhaseⅡ Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Disease control rate
研究概览
简要总结
Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.
详细描述
Currently,there is no standard second-line therapy for esophageal squamous cell carcinoma.More effective therapy for patients with this disease who developed disease progression after first line therapy is needed.Although Erlotinib is recommended in NCCN Guideline Version 2.2013,there is still insufficient evidence on EGFR-TKI as second-line therapy for esophageal squamous carcinoma.Therefore,further research is necessary.In this phase II study,we evaluate the efficacy and safety of Icotinib Hydrochloride as treatment for patients with recurrent or metastasis esophageal squamous carcinoma after failure of conventional chemotherapy,and analyse the value of biomarkers of these patient to identify who benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients have provided a signed Informed Consent Form
- •Age: 18-75 years old
- •Histologically confirmed diagnosis of esophageal squamous cell carcinoma
- •Patients have Received and progressed on 1 line of prior Fluoropyrimidine, platinum or taxane based palliative chemotherapy
- •Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
- •Life expectancy ≥ 3 months
- •Karnofsky score ≥70
- •Patient has adequate bone marrow and organ function
- •Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- •Platelets ≥ 75 x 109/L
- •Hemoglobin ≥ 9.0 g/dL
- •Patient has adequate liver function
- •AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
- •Serum bilirubin ≤ 2 x ULN
- •Creatinine ≤ 1.5 times ULN
- •No malabsorption or other gastrointestinal disorders affecting drug absorption.
- •No serious complications such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever > 38 ℃.
- •Expect good compliance
排除标准
- •Patient has received previous treatment with EGFR inhibitors
- •Patient is currently receiving Phenytoin, rifampin, barbiturates, C Masi Bing
- •Known severe hypersensitivity to Icotinib or any of the excipients of this product
- •CNS metastases without radiotherapy and/or surgery
- •Patients with treated CNS metastases may participate in this trial,except for those who must receive hormone therapy and those whose prior hormone therapy for CNS metastases is less than 4 weeks
- •Evidence of clinically active Interstitial Lung Diseases
- •Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases
- •Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ
- •psychiatric illness that would prevent the patient from giving informed consent
- •Patient is concurrently using other approved or investigational antineoplastic agent
- •Pregnant or lactating women
研究组 & 干预措施
Icotinib Hydrochloride
Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.
干预措施: Icotinib Hydrochloride (Drug)
结局指标
主要结局
Disease control rate
时间窗: for up to 6 months
Disease control rate of tumor
次要结局
- Overall survival(Time from day 1 to date of death)
- EORTC QLQ-C30 and QLQ-OES18(Time from day 1 to date of death)
- Time to progression(Time from day 1 to date of documented disease progression)
- Adverse event(Each follow up vist, assessed up to 12 months)
研究者
Yuhong Li
MD
Sun Yat-sen University