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：	ChiCTR2000039438
最近更新日期： Date of Last Refreshed on：	2021-01-29 19:24:29
注册时间： Date of Registration：	2020-10-28 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	王艺医师：请联系我们上传正式版伦理审批文件。晚期不可切除非小细胞肺癌免疫治疗疗效预测因子研究
Public title：	Study on predictors of immunotherapy efficacy of advanced non-resectable non-small cell lung cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	晚期不可切除非小细胞肺癌免疫治疗疗效预测因子研究
Scientific title：	Study on predictors of immunotherapy efficacy of advanced non-resectable non-small cell lung cancer
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：	王艺	研究负责人：	刘宏
Applicant：	Yi Wang	Study leader：	Hong Liu
申请注册联系人电话： Applicant telephone：	+86 18560087705	研究负责人电话： Study leader's telephone：	+86 18560081322
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：	dr.wangyi@163.com	研究负责人电子邮件： Study leader's E-mail：	liuhongy67@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：	山东省济南市历下区文化西路107号	研究负责人通讯地址：	山东省济南市历下区文化西路107号
Applicant address：	107 Wenhua Road West, Lixia District, Ji'nan, Shandong, China	Study leader's address：	107 Wenhua Road West, Lixia District, Ji'nan, Shandong, 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：	山东大学齐鲁医院
Applicant's institution：	Qilu Hospital of Shandong University
研究负责人所在单位：	山东大学齐鲁医院
Affiliation of the Leader：	Qilu Hospital of Shandong 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：	KYLL-202008（KS）-008	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：	山东大学齐鲁医院科研伦理委员会
Name of the ethic committee：	Research Ethics Committee of Qilu Hospital, Shandong University
伦理委员会批准日期： Date of approved by ethic committee：	2020-08-28 00:00:00
伦理委员会联系人：	陈晓阳
Contact Name of the ethic committee：	Chen xiaoyang
伦理委员会联系地址：	山东省济南市历下区文化西路107号
Contact Address of the ethic committee：	107 Wenhua Road West, Lixia District, Ji'nan, Shandong, 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：

山东大学齐鲁医院

Primary sponsor：

Qilu Hospital of Shandong University

研究实施负责（组长）单位地址：

山东省济南市历下区文化西路107号

Primary sponsor's address：

107 Wenhua Road West, Lixia District, Ji'nan, Shandong, 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)：	山东	市(区县)：	济南
Country：	China	Province：	Shandong	City：	Ji'nan
单位(医院)：	山东大学齐鲁医院	具体地址：	历下区文化西路107号
Institution hospital：	Qilu Hospital of Shandong University	Address：	107 Wenhua Road West, Lixia District

经费或物资来源：

自筹经费

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：

通过对患者免疫治疗前后相关基因指标变化的分析，探索免疫治疗新的疗效预测方法。

Objectives of Study：

Through the analysis of the changes of related gene indicators before and after immunotherapy, explore new methods for predicting the efficacy of immunotherapy.

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. The researcher judges that continuing the research and treatment is in the best interests of the subjects, and the subjects do not need to start other anti-tumor treatments immediately;
2. The subject's ECOG score is 0 or 1, and can tolerate the study treatment;
3. If the functions of main organs are normal, patients need to meet the following hematological indicators:
(1) blood routine examination:
HB >= 90 g/L;
ANC >= 1.5×10^9/L;
PLT >= 60×10^9/L;
(2) biochemical examination:
ALB >= 2^9 g/L;
ALT and AST < 2.5'ULN;
TBIL <= 2′ULN;
CRE <= 1.5'ULN;
(Only one of the two indexes of albumin and bilirubin in Child-Pugh rating is 2 points.)
4. Before continuing the research and treatment, the subject must sign an informed consent form and be informed of the possible risks, discomforts and other treatment options described in the informed consent form;
5. Continuing research and treatment must be reviewed and approved by the main investigator of this research center. The study will be divided into 3 stages: screening period, treatment period (visit period), and follow-up period. All subjects in the study need to meet all entry and exclusion criteria.
6. Aged 18-80 years, both male and female are allowed;
7. The expected survival period of the subject is greater than 3 months;
8. Be able to obtain biological samples that meet the quality standards of experimental research; (tumor cell content >= 20%);
9. The curative effect information can be collected according to the RECIST 1.1 standard for the curative effect evaluation standard of solid tumors, and the measurable lesions that can be examined by CT or MRI;
10. Patients voluntarily join this study, all need to sign an informed consent form, have good compliance, and cooperate with follow-up.

排除标准：

1. 受试者存在任何活动性、已知或可疑自身免疫疾病，或全身系统性使用免疫抑制治疗的患者不予入组；
2. 排除高度怀疑有间质性肺炎的患者；或可能会干扰可疑的药物相关肺毒性的检测或处理的患者；
3. 活动性肺结核的患者需排除。怀疑有活动性TB的患者，需检查胸部X线、痰液以及通过临床症状和体征排除；
4. 有颅内肿瘤，脑外伤，用药可能导致脑水肿的患者需排除；
5. EGFR突变或者ALK融合阳性的患者；
6. 诊断为免疫缺陷病或首次给药前 14 天内接受系统性激素治疗（例如相当于每天>10mg强的松等量的激素治疗）或使用过任何其他形式的免疫抑制治疗；注：如果受试者未患活动性自身免疫病，允许使用相当于每天≤10 mg 强的松的激素作为肾上腺替代治疗。允许受试者使用局部、眼用、关节内、鼻内和吸入糖皮质激素（系统性吸收量极低）。允许使用短时间糖皮质激素用于预防（例如用于造影剂过敏）或治疗非自身免疫疾病（例如造影剂过敏所致迟发型超敏反应）。
7. 5 年内出现其他原发性恶性肿瘤，经过根治性治疗的局部可治愈的恶性肿瘤除外（例如基底或鳞状细胞皮肤癌、浅表性膀胱癌或前列腺、宫颈或乳腺原位癌等除外）；
8. 放化疗引起的≥2 级肺炎（未经系统性激素治疗的 2 级肺炎在 14 天内恢复到 1 级或以下，有间质性肺病并且此病有症状；研究者认为既往肺部病史可能会干扰药物相关肺毒性的判断或治疗的受试者也需要排除；
9. 1 年内有活动性肺结核感染病史，超过 1 年以前有活动性肺结核感染病史的受试者如果经研究者判断目前无活动性肺结核证据，则认为其适合入组；
10. 有炎性肠炎病史或现患有炎性肠病（如克罗恩病和溃疡性结肠炎）；
11. 已知有人类免疫缺陷病毒（HIV）病毒感染病史和/或获得性免疫缺陷综合症的患者；
12. 慢性乙型肝炎活动期或活动性丙型肝炎受试者。筛选期乙型肝炎病毒表面抗原（HBsAg）阳性或丙型肝炎病毒（HCV）抗体阳性的受试者，必须再进一步通过乙型肝炎病毒（HBV）DNA滴度检测（排除高于2500拷贝[cps]/mL或 500 IU/mL）和HCV RNA 检测（排除超过测定法的检测下限），在排除了需接受治疗的活动性乙型肝炎或丙型肝炎感染之后，方可入组。乙肝病毒携带者、经药物治疗后稳定的乙肝（DNA滴度不得高于 2500拷贝[cps]/mL或 500 IU/mL）和已治愈的丙肝受试者可以入组；
13. 14 天患有需要系统性治疗的活动性感染；
14. 接受过器官移植；
15. 已知有酗酒或药物滥用史；
16. 对其他单克隆抗体产生过严重过敏反应（CTCAE v4.03 分级≥3级）；
17. 患有不可控制的合并疾病，包括但不限于症状性的充血性心力衰竭、不可控制的高血压、不稳定心绞痛、心率失常、活动性消化性溃疡或出血性疾病。

Exclusion criteria：

1. Patients who have any active, known or suspected autoimmune diseases, or systemic immunosuppressive treatments are not allowed to be included in the group;
2. Exclude patients who are highly suspected of having interstitial pneumonia; or patients who may interfere with the detection or treatment of suspected drug-related lung toxicity;
3. Patients with active tuberculosis should be excluded. Patients who are suspected of having active TB should be checked for chest X-ray, sputum, and excluded through clinical symptoms and signs;
4. Patients with intracranial tumors, brain trauma, and medications that may cause brain edema should be excluded;
5. Patients with EGFR mutation or ALK fusion positive;
6. Patients was diagnosed with immunodeficiency or received systemic hormone therapy (for example, hormone therapy equivalent to > 10mg prednisone per day) within 14 days before the first administration, or used any other form of immunosuppressive therapy; Note: If the subject does not suffer from active autoimmune diseases, hormones equivalent to <= 10 mg of prednisone per day are allowed as adrenal replacement therapy. Subjects are allowed to use topical, ophthalmic, intra-articular, intranasal and inhaled corticosteroids (very low systemic absorption). Allows the use of short-term glucocorticoids for prevention (for example, contrast agent allergy) or treatment of non-autoimmune diseases (for example, delayed type hypersensitivity caused by contrast agent allergy).
7. Other primary malignant tumors appear within 5 years, except for locally curable malignant tumors that have undergone radical treatment (except for basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast, etc. );
8. Grade 2 pneumonia caused by radiotherapy and chemotherapy (Grade 2 pneumonia that has not been treated with systemic hormones returns to grade 1 or below within 14 days, with interstitial lung disease and symptoms of the disease; the investigator believes that the previous history of lung disease may be Subjects who interfere with the judgment or treatment of drug-related pulmonary toxicity also need to be excluded;
9. Subjects with a history of active pulmonary tuberculosis infection within 1 year, and a history of active pulmonary tuberculosis infection more than 1 year ago, if the investigator judges that there is no evidence of active pulmonary tuberculosis, they are considered suitable for inclusion;
10. A history of inflammatory bowel disease or current inflammatory bowel disease (such as Crohns disease and ulcerative colitis);
11. Patients with known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome;
12. Subjects with active chronic hepatitis B or active hepatitis C. Subjects who are positive for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody during the screening period must pass the hepatitis B virus (HBV) DNA titer test (exclude more than 2500 copies [cps ]/mL or 500 IU/mL) and HCV RNA testing (excluded from exceeding the lower limit of detection of the assay), after excluding active hepatitis B or hepatitis C infection requiring treatment, can be included in the group. Carriers of hepatitis B virus, hepatitis B that is stable after drug treatment (DNA titer shall not be higher than 2500 copies [cps]/mL or 500 IU/mL) and cured hepatitis C subjects can be included in the group;
13. Suffered from an active infection requiring systemic treatment for 14 days;
14. Have received an organ transplant;
15. Known history of alcohol or drug abuse;
16. Severe allergic reactions to other monoclonal antibodies (CTCAE v4.03 grade >= 3);
17. Suffer from uncontrollable comorbid diseases, including but not limited to symptomatic congestive heart failure, uncontrollable hypertension, unstable angina, arrhythmia, active peptic ulcer or bleeding disease.

研究实施时间：

Study execute time：

从 From 2020-11-01 00:00:00至 To 2024-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2020-11-01 00:00:00 至 To 2022-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	60
Group：	Experimental group	Sample size：	60
干预措施：	同步放化疗后序贯卡瑞利珠单抗维持治疗	干预措施代码：
Intervention：	Sequential carrelizumab maintenance treatment after concurrent radiotherapy and chemotherapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	山东	市(区县)：	济南市
Country：	China	Province：	Shandong	City：	Jinan
单位(医院)：	山东大学齐鲁医院	单位级别：	三级甲等
Institution hospital：	Qilu Hospital of Shandong University	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 rate (PFS)	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：	次要指标
Outcome：	Overall survival (OS)	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 (ORR)	Type：	Secondary 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 (DCR)	Type：	Secondary 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：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	80	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:

不公开/Private

盲法：	N/A
Blinding：	N/A

是否共享原始数据： IPD sharing	否No
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）：	电子病历请阅读网页注册指南中关于原始数据共享的内容。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	electronic medical record
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：	病例报告表和病例收集表
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：	2020-10-28 01:08:38