今天是:2019-03-26 星期二

盐酸安罗替尼治疗晚期食管鳞癌的有效性和安全性的临床研究
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注册号:

Registration number:

ChiCTR1900021909 

最近更新日期:

Date of Last Refreshed on:

2019-03-24 

注册时间:

Date of Registration:

2019-03-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

盐酸安罗替尼治疗晚期食管鳞癌的有效性和安全性的临床研究 

Public title:

Clinical study for the efficacy and safety of erlotinib hydrochloride in the treatment of advanced esophageal squamous cell carcinoma 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

盐酸安罗替尼治疗晚期食管鳞癌的有效性和安全性的临床研究 

Scientific title:

Clinical study for the efficacy and safety of erlotinib hydrochloride in the treatment of advanced esophageal squamous cell carcinoma 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

左静 

研究负责人:

姜达 

Applicant:

Jing Zuo 

Study leader:

Da Jiang 

申请注册联系人电话:

Applicant telephone:

+86 13831192024 

研究负责人电话:

Study leader's telephone:

+86 13933191980 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

faye1022@126.com 

研究负责人电子邮件:

Study leader's E-mail:

jiangda139@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

河北省石家庄市健康路12号 

研究负责人通讯地址:

河北省石家庄市健康路12号 

Applicant address:

12 Health Road, Shijiazhuang, Hebei, China 

Study leader's address:

12 Health Road, Shijiazhuang, Hebei, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

河北医科大学第四医院 

Applicant's institution:

The Fourth Hospital of Hebei Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2018150 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

河北医科大学第四医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the Fourth Hospital of Hebei Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-28 

伦理委员会联系人:

河北医科大学第四医院医学伦理委员会 

Contact Name of the ethic committee:

Medical Ethics Committee of the Fourth Hospital of Hebei Medical University 

伦理委员会联系地址:

河北省石家庄市健康路12号 

Contact Address of the ethic committee:

12 Health Road, Shijiazhuang, Hebei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

河北医科大学第四医院 

Primary sponsor:

The Fourth Hospital of Hebei Medical University 

研究实施负责(组长)单位地址:

河北省石家庄市健康路12号 

Primary sponsor's address:

12 Health Road, Shijiazhuang, Hebei, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

河北省

市(区县):

石家庄市

Country:

China

Province:

Hebei

City:

Shijiazhuang

单位(医院):

河北医科大学第四医院

具体地址:

健康路12号

Institution
hospital:

The Fourth Hospital of Hebei Medical University

Address:

12 Health Road

经费或物资来源:

研究者自主 

Source(s) of funding:

The fund raised by researcher  

研究疾病:

食管鳞癌 

Target disease:

Esophageal squamous cell carcinoma 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

目的在于探索单药盐酸安罗替尼治疗一线治疗失败的晚期期食管鳞癌的有效性和安全性。 

Objectives of Study:

The aim is to explore the efficacy and safety of single-agent erlotinib hydrochloride in the treatment of advanced esophageal squamous cell carcinoma with first-line therapy failure. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1) 患者自愿参加本次研究,签署知情同意书;2) 组织学或细胞学明确诊断为晚期食管鳞癌,不适宜手术;3) 具有可测量病灶(RECIST 1.1); 4) 一线治疗失败的患者(治疗失败的定义:毒副作用不可耐受、治疗过程中疾病进展或治疗结束后6个月内复发);5) 年龄18-80岁,ECOG PS评分为0-1分,预期生存超过3个月;6) 主要器官功能良好,在干预前7天内,符合下列标准:① 血常规检查标准(14天内未输血状态下):a)血红蛋白(HB)≥90g/L;b)中性粒细胞绝对值(ANC)≥1.5×109/L;c)血小板(PLT)≥80×109/L。② 生化检查需符合以下标准:a)总胆红素(TBIL)≤1.5倍正常值上限(ULN) ;b)丙氨酸氨基转移酶(ALT)和天门冬氨酸氨基转移酶AST≤2.5ULN ALT≤2.5ULN,如伴肝转移,则ALT和AST≤5ULN;c)血清肌酐(Cr)≤1.5ULN或肌酐清除率(CCr)≥60ml/min(根据Cockroft-Gault公式计算)。③ 多普勒超声评估:左室射血分数 (LVEF) ≥正常值低限 (50%)。7) 育龄女性应同意在研究期间和研究结束后6个月内必须采用避孕措施(如宫内节育器,避孕药或避孕套);在研究入组前的7天内血清或尿妊娠试验阴性,且必须为非哺乳期患者;男性应同意在研究期间和研究期结束后6个月内必须采用避孕措施的患者。 

Inclusion criteria

1. Patients volunteered to participate in the study, signed informed consent; 2. histological or cytological diagnosis of advanced esophageal squamous cell carcinoma, unsuitable for surgery; 3. measurable lesions (RECIST 1.1); 4. failure of first-line treatment Patients (Definition of treatment failure: toxic side effects are intolerable, disease progression during treatment or recurrence within 6 months after treatment); 5. Aged 18-80 years, ECOG PS score 0-1, expected survival over 3 Months; 6. The main organs function well, within 7 days before the intervention, meet the following criteria: (1) blood routine examination criteria (without blood transfusion within 14 days): hemoglobin (HB) ≥ 90g / L; Absolute granulocyte count (ANC) ≥ 1.5 × 10^9 / L; platelets (PLT) ≥ 80 × 10^9/L; (2) Biochemical examinations are subject to the following criteria: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5ULN ALT ≤ 2.5ULN, such as with liver metastasis, ALT and AST ≤ 5ULN; serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min (calculated according to the Cockroft-Gault formula); (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%); 7. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy tests within 7 days prior to study enrollment, It must be a non-lactating patient; men should agree to patients who must use contraception during the study period and within 6 months of the end of the study period. 

排除标准:

1) 既往使用过盐酸安罗替尼的患者;2) 5年内出现过或当前同时患有其它恶性肿瘤,治愈的子宫颈原位癌、非黑色素瘤的皮肤癌和表浅的膀胱肿瘤除外 [Ta (非浸润性肿瘤),Tis (原位癌) 和T1 (肿瘤浸润基膜)];3) 入组前4周内或在本次研究用药期间计划进行全身抗肿瘤治疗,包括细胞毒疗法、信号转导抑制剂、免疫疗法(或在接受试验药物治疗前6周内使用过丝裂霉素C);4) 具有影响口服药物的多种因素(如吞咽困难、幽门梗阻、肠梗阻和慢性腹泻等)者; 5) 存在严重疾病或症状影响生存时间(小于3个月)或完成研究;6) 存在任何重度和/或未能控制的疾病的患者,包括:a)血压控制不理想者(收缩压≥150 mmHg,舒张压≥100 mmHg);b)患有I级以上心肌缺血或心肌梗塞、心律失常(包括QTc ≥480ms)及≥2级充血性心功能衰竭(纽约心脏病协会(NYHA)分级);c)活动性或未能控制的严重感染(≥CTC AE 2级感染);d)肝硬化、失代偿性肝病,活动性肝炎或慢性肝炎需接受抗病毒治疗;e)肾功能衰竭需要血液透析或腹膜透析;f)有免疫缺陷病史,包括HIV阳性或患有其它获得性、先天性免疫缺陷疾病,或有器官移植史者;g)糖尿病控制不佳(空腹血糖(FBG)>10mmol/L);h)尿常规提示尿蛋白≥++,且证实24小时尿蛋白定量>1.0 g者;i)具有癫痫发作并需要治疗的患者; 7) 分组前 28 天内接受了重大外科治疗、切开活检或明显创伤性损伤;8) 影像学显示肿瘤已侵犯重要血管或经研究者判断在后续研究期间肿瘤极有可能侵袭重要血管而引起致命大出血的患者;9) 不管严重程度如何,存在任何出血体质迹象或病史的患者;在分组前4周内,出现任何出血或流血事件≥CTCAE 3级的患者,存在未愈合创口、溃疡或骨折;10) 6个月内发生过动/静脉血栓事件,如脑血管意外(包括暂时性缺血性发作)、深静脉血栓及肺栓塞者; 11) 具有精神类药物滥用史且无法戒除或有精神障碍者;12) 4周内参加过其他抗肿瘤药物临床试验;13) 根据研究者判断有严重危害患者安全或影响患者完成研究的伴随疾病者。 

Exclusion criteria:

1) Patients who have previously used erlotinib HCl; 2) have had or have other malignant tumors within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [ Ta (non-invasive tumor), Tis (in situ carcinoma) and T1 (tumor infiltrating basement membrane)]; 3) planned systemic anti-tumor therapy, including cytotoxic therapy, within 4 weeks prior to enrollment or during the study , signal transduction inhibitors, immunotherapy (or mitomycin C used within 6 weeks prior to receiving the test drug); 4) have multiple factors affecting oral medications (eg, dysphagia, pyloric obstruction, intestinal obstruction, and Patients with chronic diarrhea, etc.; 5) Patients with severe disease or symptoms affecting survival time (less than 3 months) or completed; 6) Patients with any severe and/or uncontrolled diseases, including: a) Unsatisfactory blood pressure control (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg); b) with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥480ms) and ≥2 grade congestive heart failure (New York heart disease) Association (NYHA) classification); c) activity Uncontrolled serious infection (≥CTC AE grade 2 infection); d) cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy; e) renal failure requires hemodialysis or peritoneal dialysis; f) a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; g) poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L); h) Urinary routine indicates urinary protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0 g; i) patients with seizures and need treatment; 7) major surgical treatment, incisional biopsy or significant trauma within 28 days before grouping Sexual injury; 8) Imaging studies indicate that the tumor has invaded an important blood vessel or that the patient is likely to invade the important blood vessel during the follow-up study and cause fatal bleeding; 9) Regardless of the severity, there is any sign or history of bleeding. Patients; any hemorrhage or bleeding episode ≥CTCAE level 3 in the first 4 weeks prior to grouping, there were unhealed wounds, ulcers or fractures; 10) Overactivity/vein occurred within 6 months Thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism; 11) those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder; 12) participated in other subjects within 4 weeks Clinical trial of anti-tumor drugs; 13) According to the investigator, there is a concomitant disease that seriously harms the patient's safety or affects the patient's completion of the study. 

研究实施时间:

Study execute time:

From2019-03-19To 2021-06-27 

干预措施:

Interventions:

组别:

Case series

样本量:

30

Group:

Case series

Sample size:

干预措施:

早餐前,空腹服用盐酸安罗替尼胶囊,每日1次,每次1粒(12mg)。连续口服2周停1周,即3周(21天)为一治疗周期。

干预措施代码:

Intervention:

Before breakfast, take the capsule of erlotinib hydrochloride on an empty stomach once a day, 1 capsule (12mg). Continuous oral administration for 2 weeks, 1 week, ie 3 weeks (21 days) for a treatment cycle.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北省 

市(区县):

石家庄市 

Country:

China 

Province:

Hebei 

City:

Shijiazhuang 

单位(医院):

河北医科大学第四医院 

单位级别:

三甲医院 

Institution
hospital:

The Fourth Hospital of Hebei Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

无进展生存期

指标类型:

主要指标 

Outcome:

Progression free survival

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疾病控制率

指标类型:

次要指标 

Outcome:

Disease control rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

客观缓解率

指标类型:

次要指标 

Outcome:

Objective response rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存期

指标类型:

次要指标 

Outcome:

Overall survival

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量

指标类型:

次要指标 

Outcome:

Quality of Life

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应的发生和严重程度

指标类型:

次要指标 

Outcome:

Occurrence and severity of adverse reactions

Type:

Secondary indicator 

测量时间点:

整个试验期间

测量方法:

Measure time point of outcome:

During the whole study

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

粪便

组织:

Sample Name:

stool

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

不适用,单臂试验

Randomization Procedure (please state who generates the random number sequence and by what method):

NA, single arm study

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

通过期刊杂志发表

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

published in journals or magazines

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例报告表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

case record form,CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-03-15
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