ChiCTR2000040267 版本V1.1 版本创建时间2021/02/12 18:15:49 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2000040267 

最近更新日期：

Date of Last Refreshed on：

 2021-02-12 18:12:27 

注册时间：

Date of Registration：

 2020-11-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

盐酸安罗替尼用于化疗联合贝伐珠单抗一线治疗后维持治疗晚期非小细胞肺癌患者的前瞻性、单臂、单中心临床研究

Public title：

A prospective, single-arm, single-center clinical study of anlotinib hydrochloride for maintenance treatment of patients with advanced non-small cell lung cancer after chemotherapy combined with bevacizumab as first-line treatment

注册题目简写：

English Acronym：

研究课题的正式科学名称：

盐酸安罗替尼用于化疗联合贝伐珠单抗一线治疗后维持治疗晚期非小细胞肺癌患者的前瞻性、单臂、单中心临床研究

Scientific title：

A prospective, single-arm, single-center clinical study of anlotinib hydrochloride for maintenance treatment of patients with advanced non-small cell lung cancer after chemotherapy combined with bevacizumab as first-line treatment

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：

郭军 

研究负责人：

郭军 

Applicant：

Jun Guo 

Study leader：

Jun Guo 

申请注册联系人电话：

Applicant telephone：

 +86 13503396777

研究负责人电话：

Study leader's
telephone：

+86 13503396777

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：

 guojun_868@sina.com

研究负责人电子邮件：

Study leader's E-mail：

 guojun_868@sina.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：

河北邢台市襄都区红星街16号

研究负责人通讯地址：

河北邢台市襄都区红星街16号

Applicant address：

16 Hongxing Road, Xiangdu District, Xingtai, Hebei, China

Study leader's address：

16 Hongxing Road, Xiangdu District, Xingtai, 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：

邢台市人民医院

Applicant's institution：

Xingtai People's Hospital

研究负责人所在单位：

邢台市人民医院

Affiliation of the Leader：

Xingtai People's Hospital

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：

 2020078

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：

邢台市人民医院伦理委员会

Name of the ethic committee：

Xingtai People's Hospital Ethics committee

伦理委员会批准日期：

Date of approved by ethic committee：

 1990-01-01 00:00:00

伦理委员会联系人：

魏庆民

Contact Name of the ethic committee：

Qingmin Wei

伦理委员会联系地址：

邢台市襄都区红星街16号

Contact Address of the ethic committee：

16 Hongxing Road, Xiangdu District, Xingtai, 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：

邢台市人民医院

Primary sponsor：

Xingtai People's Hospital

研究实施负责（组长）单位地址：

河北邢台市襄都区红星街16号

Primary sponsor's address：

16 Hongxing Road, Xiangdu District, Xingtai, 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

市(区县)：

邢台

Country：

China

Province：

Hebei

City：

Xingtai

单位(医院)：

邢台市人民医院

具体地址：

河北邢台市襄都区红星街16号

Institution
hospital：

Xingtai People's Hospital

Address：

16 Hongxing Road, Xiangdu District

经费或物资来源：

自筹

Source(s) of funding：

self-financing

研究疾病：

非小细胞肺癌  

Target disease：

Non-small cell lung cancer

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

单臂 

Study design：

Single arm 

研究目的：

探索盐酸安罗替尼单药用于化疗联合贝伐珠单抗一线治疗后维持治疗晚期非小细胞肺癌患者的疗效和安全性  

Objectives of Study：

To assess the efficacy and safety of anlotinib hydrochloride as a single agent for chemotherapy combined with bevacizumab in the first-line maintenance treatment of patients with advanced non-small cell lung cancer

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1)经细胞学或组织学确诊为非小细胞肺癌（NSCLC）的初诊患者；按照2017年新版UICC肺癌分期标准（第8版）诊断为ⅢB、ⅢC或Ⅳ期，且无已知EGFR敏感突变及ALK突变的患者（注：ⅢB、ⅢC必须是无法行根治性手术且未接受同步放化疗的患者）；
2)一线已接受含铂双药联合贝伐珠单抗治疗4-6周期后病情缓解或稳定者：按RECIST1.1标准判定为完全缓解（CR），部分缓解（PR）或稳定（SD）；
3)患者须在末次含铂双药联合贝伐珠单抗一线化疗周期开始后≤6周（42天）进行入组；
4)年龄：18岁及以上；
5)ECOG PS 0~2；
6)预计生存期≥3个月；
7)按RECIST1.1标准，一线化疗前，患者至少有一处影像学（CT、MRI）可测量或可评估病灶；该病灶3个月内未经放射治疗。靶病灶最长径需大于等于10mm（淋巴结短轴大于等于15mm才能作为靶病灶）；
8)女性：对于所有可能怀孕的妇女必须在开始治疗之前的7天内做妊娠试验、或在治疗期间及结束后的3个月内采取医学许可的避孕方法；血清或尿妊娠试验必须为阴性，必须为非哺乳期；男性：外科手术绝育或治疗期间及结束后的3个月内采取避孕措施；
9)器官的功能水平必须符合下列要求：
血常规：ANC≥1.5×109/L；PLT≥100×109/L；Hb≥90g/L
血生化：TBIL≤1.5×ULN：ALT和AST≤2.5×ULN；对于有肝转移灶者，ALT和AST≤5×ULN；BUN和Cr≤1.5×ULN且肌酐清除率≥50ml/min；
心脏彩超：LVEF≥50%；
12导联心电图：Fridericia法校正的QT间期（QTcF）男性<450ms、女性<470ms；
10)受试者有能力理解和签署知情同意书，必须在进行任何筛选评估前，签署知情同意书。

Inclusion criteria

1) Newly diagnosed patients with non-small cell lung cancer (NSCLC) confirmed by cytology or histology; according to the 2017 new UICC lung cancer staging standard (8th edition) diagnosed as stage IIIB, IIIC or IV, and no known EGFR sensitive mutations Patients with ALK mutations (Note: ⅢB and ⅢC must be patients who cannot undergo radical surgery and have not received concurrent radiotherapy and chemotherapy);
2) First-line patients who have received platinum-containing dual-drug combined with bevacizumab for 4-6 cycles of remission or stable disease: According to RECIST1.1 standard, it is judged as complete remission (CR), partial remission (PR) or stable (SD)
3) Patients must be enrolled ≤6 weeks (42 days) after the start of the last platinum-containing dual-drug plus bevacizumab first-line chemotherapy cycle;
4) Age: 18 years old and above;
5) ECOG PS 0~2;
6) Estimated survival time ≥ 3 months;
7) According to the RECIST1.1 standard, before the first-line chemotherapy, the patient has at least one imaging (CT, MRI) measurable or evaluable lesion; the lesion has not been treated with radiation within 3 months. The longest diameter of the target lesion must be greater than or equal to 10mm (the short axis of the lymph node is greater than or equal to 15mm to be the target lesion);
8) Women: For all women who may become pregnant, a pregnancy test must be taken within 7 days before the start of treatment, or a medically approved method of contraception during the treatment and within 3 months after the end; the serum or urine pregnancy test must be negative, Must be non-lactating; male: use contraceptive measures during surgical sterilization or treatment and within 3 months after the end;
9) The functional level of organs must meet the following requirements:
Blood routine: ANC≥1.5×109/L; PLT≥100×109/L; Hb≥90g/L
Blood biochemistry: TBIL≤1.5×ULN: ALT and AST≤2.5×ULN; for patients with liver metastases, ALT and AST≤5×ULN; BUN and Cr≤1.5×ULN and creatinine clearance ≥50ml/min;
Heart color Doppler ultrasound: LVEF≥50%;
12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method <450ms for males and <470ms for females;
10)The subject has the ability to understand and sign the informed consent form, and must sign the informed consent form before any screening assessment.

排除标准：

1)小细胞肺癌（包括小细胞肺癌与非小细胞肺癌混合的肺癌）；
2)侵犯肺门的肺鳞癌，或伴有咯血的非小细胞肺癌，包括3个月内发生过肺出血/咯血（>1/2茶匙的鲜红血液）；或显著临床意义的出血症状或具有明确的出血倾向，如消化道出血、出血性胃溃疡、基线期大便潜血++及以上，或患有脉管炎等
3)患者正在参加其他临床研究或距离前一项临床研究治疗结束时间不足4周；
4)伴有颅内急性，亚急性脑梗，颅内病灶急性，亚急性出血的患者；
5)由于任何既往治疗引起的高于CTC AE(5.0)2级以上的尚未缓解的急性毒性反应期；
6)具有影响口服药物的多种因素（比如无法吞咽、胃肠道切除术后、慢性腹泻和肠梗阻等）者；
7)具有严重症状的、已播散到内脏的、短期内有出现危及生命的并发症风险的晚期患者；
8)存在其他重度和/或未能控制的疾病危及生命的患者；
9)入组前1个月内接受了重大外科治疗、切开活检或明显创伤性损伤且尚未愈合的患者；
10)不管严重程度如何，存在任何出血体质迹象或病史的患者；存在未愈合创口、胃肠道溃疡或骨折；
11)6个月内发生过动/静脉血栓事件，深静脉血栓及肺栓塞者；
12)具有精神类药物滥用史且无法戒除或有精神障碍者；
13)根据研究者的判断，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) Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
2) Lung squamous cell carcinoma that invades the hilar, or non-small cell lung cancer with hemoptysis, including pulmonary hemorrhage/hemoptysis (>1/2 teaspoon of bright red blood) within 3 months; or significant clinically significant bleeding symptoms or Have a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above, or suffering from vasculitis, etc.
3) The patient is participating in other clinical studies or is less than 4 weeks from the end of the previous clinical study;
4) Patients with acute intracranial, subacute cerebral infarction, acute intracranial lesions, and subacute hemorrhage;
5) The unresolved acute toxicity period that is higher than CTC AE (5.0) level 2 or more caused by any previous treatment;
6) Those who have multiple factors that affect oral medications (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
7) Advanced patients who have severe symptoms, have spread to the internal organs, and are at risk of life-threatening complications in the short term;
8) There are other life-threatening patients with severe and/or uncontrolled diseases;
9) Patients who have received major surgical treatment, open biopsy or obvious traumatic injury within 1 month before enrollment and have not healed;
10) Regardless of the severity, patients with any signs of bleeding or medical history; unhealed wounds, gastrointestinal ulcers or fractures;
11) Those who have experienced arterial/venous thrombosis, deep vein thrombosis and pulmonary embolism within 6 months;
12) Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders;
13)According to the judgment of the investigator, there are persons with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.

研究实施时间：

Study execute time：

从 From 2020-12-01 00:00:00至 To 2022-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-12-01 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

实验组

样本量：

 30

Group：

Case series

Sample size：

干预措施：

口服安罗替尼12mg/qd,连用两周停一周, Q3W,直到疾病进展

干预措施代码：

Intervention：

Oral Anlotinib 12mg/qd, Stop using for one week after two consecutive weeks,Q3W, until disease progression

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北 

市(区县)：

 邢台 

Country：

China

Province：

Hebei

City：

单位(医院)：

 邢台市人民医院 

单位级别：

 三甲医院 

Institution
hospital：

Xingtai people's hospital

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：

PFS

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

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：

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 岁 years
最大 Max age 75 岁 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）：

未使用

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

Not used

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

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）：

试验完成后6个月内公开

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

Within six months after the trial complete

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：

病历记录表

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

Case Record Form, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2020-11-26 23:01:50