中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR1900027462
最近更新日期： Date of Last Refreshed on：	2020-01-05 19:06:05
注册时间： Date of Registration：	2019-11-14 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	静脉泵注恩度联合免疫一线治疗晚期或转移性驱动基因阴性的非小细胞肺癌的真实性世界的研究
Public title：	The real world of intravenous infusion of endostar combined with first-line immunotherapy for advanced or metastasis driven gene negative NSCLC
注册题目简写：
English Acronym：
研究课题的正式科学名称：	静脉泵注恩度联合免疫一线治疗晚期或转移性驱动基因阴性的非小细胞肺癌的真实性世界的研究
Scientific title：	The real world of intravenous infusion of endostar combined with first-line immunotherapy for advanced or metastasis driven gene negative NSCLC
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：	黄德馨	研究负责人：	曾爱屏
Applicant：	Huang Dexin	Study leader：	Zeng Aiping
申请注册联系人电话： Applicant telephone：	+86 0771-5334955	研究负责人电话： Study leader's telephone：	+86 0771-5334955
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：	2379952220@qq.com	研究负责人电子邮件： Study leader's E-mail：	zengaipingone@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：	广西南宁市河堤路71号	研究负责人通讯地址：	广西南宁市河堤路71号
Applicant address：	71 Hedi Road, Nanning, Guangxi Zhuang Autonomous Region, China	Study leader's address：	71 Hedi Road, Nanning, Guangxi Zhuang Autonomous Region, 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：	广西医科大学附属肿瘤医院
Applicant's institution：	Guangxi Medical University Affiliated Tumor Hospital
研究负责人所在单位：	广西医科大学附属肿瘤医院
Affiliation of the Leader：	Guangxi Medical University Affiliated Tumor 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：	ChiECRCT20190249	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：	中国注册临床试验伦理委员会
Name of the ethic committee：	China Registered Clinical Trial Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2019-11-30 00:00:00
伦理委员会联系人：	米娜
Contact Name of the ethic committee：	Mina
伦理委员会联系地址：	中国香港特别行政区九龙塘浸会大学道中国临床试验注册中心香港中心
Contact Address of the ethic committee：	Chinese Clinical Trial Registry Hong Kong Center, Hong Kong Baptist University Road, Hong Kong SAR, 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：

广西医科大学附属肿瘤医院

Primary sponsor：

Guangxi Medical University Affiliated Tumor Hospital

研究实施负责（组长）单位地址：

广西南宁市河堤路71号

Primary sponsor's address：

71 Hedi Road, Nanning, Guangxi Zhuang Autonomous Region, 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)：	广西壮族自治区	市(区县)：	南宁
Country：	China	Province：	Guangxi Zhuang Autonomous Region	City：	Nanning
单位(医院)：	广西医科大学附属肿瘤医院	具体地址：	河堤路71号
Institution hospital：	Guangxi Medical University Affiliated Tumor Hospital	Address：	71 Hedi Road

经费或物资来源：

无

Source(s) of funding：

nothing

研究疾病：

非小细胞肺癌

Target disease：

NSCLC

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：

随机平行对照

Study design：

Parallel

研究目的：

观察和评价真实世界中静脉泵注重组人血管内皮抑制素（恩度）联合含铂双药与免疫药物治疗驱动基因阴性的晚期或转移性非小细胞肺癌患者的有效性和安全性。

Objectives of Study：

To observe and evaluate the efficacy and safety of intravenous injection of recombinant human endostatin (endostar) combined with platinum containing dual drugs and immunodrugs in the real world in the treatment of advanced or metastatic non-small cell lung cancer patients with negative driving genes.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. According to TNM stage of lung cancer (8th Edition) issued by International Association for lung cancer research and Joint Committee of American Cancer classification, NSCLC which is proved by histology or cytology and can not be treated surgically and can not receive radical concurrent radiotherapy and chemotherapy in local advanced stage or metastatic stage (III B, III C or IV stage).
2. NSCLC with EGFR gene mutation negative and alk negative were detected.
3. Patients who have not received systemic radiotherapy and chemotherapy before or who have been followed up for more than 6 months after adjuvant chemotherapy.
4. There must be at least one evaluable lesion judged according to rrecist standard (the longest diameter on spiral CT is at least 10 mm, and the longest diameter on general CT is at least 20 mm).
5. Men or women aged 18 to 75 years.
6. ECoG PS 0 or 1.
7. Estimated survival time >= 12 weeks.
8. Adequate blood function: absolute neutrophil count (ANC) >= 2 x 10^9 / L, platelet count >= 100 x 10^9 / L and hemoglobin >= 9 g / dl.
9. Adequate liver function: total bilirubin <= upper limit of normal value (ULN); AST and alt<= upper limit of normal value (ULN); alkaline phosphatase <= upper limit of normal value (ULN).
10. Adequate renal function: serum creatinine <= upper limit of normal value (ULN) or calculated creatinine clearance >= 60ml / min.
11. For patients who have had previous surgery, it is required that more than 4 weeks have passed since the start of the study and the patients have recovered.
12. Women with complete uterus must have negative pregnancy test results within 28 days before entering the study (unless it is 24 months since amenorrhea). If the pregnancy test is more than 7 days from the first administration, a urine pregnancy test is required for validation (within 7 days before the first administration).
13. Sign the informed consent (the informed consent needs to be approved by the independent ethics committee, and the informed consent of the patient should be obtained before starting any substantive trial procedure).

排除标准：

1. 受试者有癌性脑膜炎。
2. 排除有活动性中枢神经系统（CNS）转移的受试者。如果受试者的CNS转移能够充分治疗，并且受试者的神经系统症状能够在入选前至少2周恢复到基线水平（与CNS治疗有关的残留体征或症状除外），则可以参加研究。此外，受试者还必须是不用皮质类固醇的受试者，或接受剂量稳定或逐渐降低的≤10mg/天的强的松（或等价物）。
3. 排除患有活动性、已知或可疑的自身免疫性疾病的受试者。患有I型糖尿病、只需接受激素替代治疗的甲状腺功能减退症、无需进行全身治疗的皮肤疾病（例如，白癜风、银屑病或脱发），或预计在无外部触发因素的状态下情况不会再现的受试者可以入选。
4. 入组之前的14天内有需要全身用皮质类固醇（剂量相当于>10 mg强的松/天）或其他免疫抑制药物治疗的受试者。使用吸入性或外用皮质类固醇的受试者，以及肾上腺皮质类固醇替代治疗剂量相当于>10 mg强的松/天的受试者，如果没有活动性自身免疫性疾病，则可以参加研究。
5. 乙型肝炎病毒表面抗原（HBV sAg）或丙型肝炎病毒抗体（HCV Ab）阳性，说明有急性或慢性感染。
6. 根据胸部X线检查、痰液检查以及临床查体，判断有活动性肺结核（TB）感染。前1年内有活动性肺结核感染病史的患者，即使已经治疗，也要排除；超过1年以前有活动性肺结核感染病史的患者，也要排除，除非证明以前所用的抗结核治疗的疗程和种类都恰当。
7. 原有严重心脏病者，包括：充血性心力衰竭、不能控制的高危性心律失常、不稳定性心绞痛、心肌梗塞、重度心瓣膜疾病以及顽固性高血压。
8. 妊娠或哺乳期患者。
9. 患者（男性或女性）存在生育可能性但不愿意或未采取有效的的避孕措施。
10. 同时接受其他临床研究的试验性治疗（处于临床研究的治疗期）。
11. 已知对可能使用的化疗药物过敏的。
12. 有证据证明患有其它疾病，神经或代谢功能异常，体检异常或实验室检查异常而怀疑可能有对研究药物有禁忌的或会引起与治疗有关的并发症的高度危险的情况。

Exclusion criteria：

1. The subjects had cancerous meningitis.
2. Subjects with active central nervous system (CNS) metastasis were excluded. Subjects may participate in the study if their CNS metastasis is adequately treated and their neurological symptoms return to baseline at least 2 weeks prior to inclusion (except for residual signs or symptoms related to CNS treatment). In addition, the subjects must be subjects who do not use corticosteroids, or receive prednisone (or equivalent) with a stable or gradually reduced dose of <= 10mg / day.
3. Subjects with active, known or suspected autoimmune diseases were excluded. Subjects with type I diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases without systemic treatment (e.g., vitiligo, psoriasis or alopecia), or who are not expected to recur without external triggers, may be selected.
4. Subjects requiring systemic corticosteroids (dose equivalent to > 10 mg prednisone / day) or other immunosuppressive drugs within 14 days before enrollment. Subjects who used inhaled or topical corticosteroids, and subjects whose doses of corticosteroid replacement therapy were equivalent to > 10 mg prednisone / day, could participate in the study if there was no active autoimmune disease.
5. Hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV AB) is positive, indicating acute or chronic infection.
6. According to the chest X-ray examination, sputum examination and clinical examination, it is judged that there is active tuberculosis (TB) infection. Patients with a history of active tuberculosis infection in the previous year should be excluded even if they have been treated; patients with a history of active tuberculosis infection more than one year ago should also be excluded unless it is proved that the course and type of anti tuberculosis treatment used before are appropriate.
7. The former serious heart disease includes congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease and stubborn hypertension.
8. Pregnant or lactating patients.
9. The patient (male or female) has the possibility of childbearing but is unwilling or does not take effective contraceptive measures.
10. At the same time, they received experimental treatment of other clinical studies (in the treatment period of clinical studies).
11. Known to be allergic to chemotherapy drugs that may be used.
12. There is evidence to prove that patients with other diseases, abnormal neurological or metabolic functions, abnormal physical examination or laboratory examination may be suspected of contraindications to the study drug or high risk of complications related to treatment.

研究实施时间：

Study execute time：

从 From 2019-12-31 00:00:00至 To 2022-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2019-12-31 00:00:00 至 To 2020-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	112
Group：	experimental group	Sample size：	112
干预措施：	恩度联合PD-1/PD-L1及常规化疗	干预措施代码：
Intervention：	Endostar, PD-1/PD-L1 and conventional chemotherapy	Intervention code：

组别：	对照组	样本量：	112
Group：	control group	Sample size：	112
干预措施：	恩度联合化疗	干预措施代码：
Intervention：	Endostar combined with chemotherapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广西壮族自治区	市(区县)：	南宁
Country：	China	Province：	Guangxi Zhuang Autonomous Region	City：	Nanning
单位(医院)：	广西医科大学附属肿瘤医院	单位级别：	三甲
Institution hospital：	Guangxi Medical University Affiliated Tumor Hospital	Level of the institution：	Tertiary A

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：	客观缓解率	指标类型：	主要指标
Outcome：	Objective response rate	Type：	Primary 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：	主要指标
Outcome：	Overall 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：	毒副反应	指标类型：	主要指标
Outcome：	AEs	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：

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：

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）：

采用系统软件SAS中的PLAN语句生成随机分配序列。将合格的研究对象按纳入顺序编号分为试验组和对照组。

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

The random assignment sequence is generated by using the PLAN statement in the system software SAS. The eligible subjects were divided into the test group and the control group according to the order of inclusion.

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：	双盲，通过SAS软件设置盲底，并由项目管理员保存
Blinding：	Double blind, setting blind bottom through SAS software, and saved by Project Manager
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	2023年6月，ResMan临床试验公共管理平台，www.medresman.org
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	In Jun 2023,the ResMan Clinical Trial Public Management Platform (www.medresman.org)
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：	数据采集使用CRF和EDC
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF and EDC
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：	2019-11-14 13:53:43