ChiCTR2100050010 版本V1.3 版本创建时间2022/04/18 06:54:37 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：

 ChiCTR2100050010 

最近更新日期：

Date of Last Refreshed on：

 2022-03-17 17:23:40 

注册时间：

Date of Registration：

 2021-08-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

化疗联合PD-1/PD-L1抑制剂序贯放疗联合PD-1/PD-L1抑制剂治疗广泛期小细胞肺癌的前瞻性、多中心、单臂临床研究

Public title：

Prospective, Multicenter, One-Arm Clinical Study Of Chemotherapy Combined With PD-1/PD-L1 Inhibitor Sequential Radiotherapy Combined With PD-1/PD-L1 Inhibitor In Extensive-stage Small Cell Lung Cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

化疗联合PD-1/PD-L1抑制剂序贯放疗联合PD-1/PD-L1抑制剂治疗广泛期小细胞肺癌

Scientific title：

Chemotherapy Combined With PD-1/PD-L1 Inhibitor Sequential Radiotherapy Combined With PD-1/PD-L1 Inhibitor In Extensive-stage 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：

叶华 

研究负责人：

林盛 

Applicant：

Ye Hua 

Study leader：

Lin Sheng 

申请注册联系人电话：

Applicant telephone：

 +86 13568637417

研究负责人电话：

Study leader's
telephone：

+86 15108187773

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：

 307524082@QQ.com

研究负责人电子邮件：

Study leader's E-mail：

 lslinsheng@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：

四川省泸州市太平街25号

研究负责人通讯地址：

四川省泸州市太平街25号

Applicant address：

25 Taiping Street, Luzhou, Sichuan, China

Study leader's address：

25 Taiping Street, Luzhou, Sichuan, 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：

西南医科大学附属医院肿瘤科

Applicant's institution：

Department of Oncology, Affiliated Hospital of Southwest Medical University

研究负责人所在单位：

西南医科大学附属医院肿瘤科

Affiliation of the Leader：

Department of Oncology, Affiliated Hospital of Southwest Medical University

是否获伦理委员会批准：

否

Approved by ethic committee：

No

伦理委员会批件文号：

Approved No. of ethic committee：

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-08-26 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

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：

西南医科大学附属医院肿瘤科

Primary sponsor：

Department of Oncology, Affiliated Hospital of Southwest Medical University

研究实施负责（组长）单位地址：

四川省泸州市太平街25号

Primary sponsor's address：

25 Taiping Street, Luzhou, Sichuan, 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)：

四川

市(区县)：

泸州

Country：

China

Province：

Sichuan

City：

Luzhou

单位(医院)：

西南医科大学附属医院肿瘤科

具体地址：

太平街25号

Institution
hospital：

Department of Oncology, Affiliated Hospital of Southwest Medical University

Address：

25 Taiping Street

经费或物资来源：

科研基金

Source(s) of funding：

scientific-research funding

研究疾病：

广泛期小细胞肺癌  

Target disease：

Extensive-stage 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：

 II期临床试验 

Study phase：

2

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

评估化疗联合PD-1/PD-L1 抑制剂序贯放疗联合PD-1/PD-L1 抑制剂治疗广泛期小细胞肺癌的有效性和安全性。  

Objectives of Study：

To evaluate the effectiveness and safety of chemotherapy combined with PD-1/PD-L1 inhibitor sequential radiotherapy combined with PD-1/PD-L1 inhibitor in extensive-stage 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.组织学或细胞学证实，胸部增强CT、肝脏及肾上腺CT、头颅磁共振、PET-CT/全身骨显像等明确分期的既往未接受过抗肿瘤治疗的广泛期SCLC患者；或既往接受过根治性治疗，但治疗完成6个月后发生疾病复发或者进展的患者；
2.患者年龄年龄18～75岁，能够表示知情同意并签订知情同意书，能够依从研究方案和随访流程；
3.患者必须有 ≥ 3处可测量病灶（按照RECIST 1.0标准）；
3.无放疗禁忌症，预期寿命大于6个月；
4.美国东部肿瘤合作组(Eastern Cooperative Group, ECOG) 评分量表评估0-2分；
5.有足够的肺功能，要求：第1秒钟用力呼吸容积（FEV1）≥1.2升/秒或≥50%预计值,术后预期（FEV1）≥30％ ；
6.既往无其他肺部恶性肿瘤史，未行针对肺部肿瘤的化疗或放疗。
7.距前次接受放疗、化疗、激素治疗4 周以上，先前治疗引起的所有不良事件已恢复到≤Ⅰ度 (CTCAE 4.0)的患者；
8.在首次用药前7天内进行的下列实验室检查，证实患者骨髓、肝肾功能符合参加研究的要求： -血红蛋白≥9.0 g/dL（可以通过输血维持或超过这个水平）； -红细胞计数≥2.0×10^9/L -中性粒细胞绝对计数（ANC）≥1.0×10^9/L； -血小板计数≥100×10^9/L； -总胆红素在正常限值内； -谷丙转氨酶、谷草转氨酶、碱性磷酸酶≤2.5倍正常值上限； -肌酐≤2.0 mg/dL；且肌酐清除率≥60ml/min； -未曾接受抗凝治疗的患者凝血酶原时间国际标准化比值（INR）≤1.5，部分凝血活酶时间(APTT)≤1.5倍正常值上限。接受全量或胃肠外抗凝药物治疗的患者只要在进入临床研究前抗凝药物的剂量稳定至少2周，并且凝血检测试验的结果在当地治疗所限制的范围以内均可以进入临床试验; 其余筛查所做的实验室检查值必须符合相关标准；
9.育龄期妇女在治疗开始前7天内检测尿及血清HCG，结果需阴性；适龄期男女患者在进入试验前，研究过程中直到停药后30天都必须采用可靠的方法避孕。可靠的避孕方法将由主要研究者或指定人员来判定。

Inclusion criteria

1. Extensive-stage SCLC patients who have not received anti-tumor therapy before, who have been confirmed by histology or cytology, chest enhanced CT, liver and adrenal CT, cranial magnetic resonance, PET-CT/whole body bone imaging, etc. Patients who have undergone radical treatment, but have disease recurrence or progression 6 months after completion of treatment;
2. The age of the patients is 18 to 75 years old, able to express informed consent and sign an informed consent form, and be able to comply with the research protocol and follow-up procedures;
3. Patients must have >= 3 measurable lesions (according to RECIST 1.0 criteria);
3. No contraindications to radiotherapy, life expectancy is more than 6 months;
4. The Eastern Cooperative Group (ECOG) scoring scale evaluates 0-2 points;
5. Sufficient lung function, requirements: forced expiratory volume in the first second (FEV1) >= 1.2 liters/second or >= 50% of the expected value, postoperative expected (FEV1) >= 30%;
6. No history of other pulmonary malignant tumors, no chemotherapy or radiotherapy for lung tumors.
7. Patients who received radiotherapy, chemotherapy and hormone therapy for more than 4 weeks, and all adverse events caused by previous treatment have recovered to <= grade I (CTCAE 4.0);
8. The following laboratory tests performed within 7 days before the first drug use confirm that the patient's bone marrow, liver and kidney functions meet the requirements for participation in the study: - Hemoglobin >= 9.0 g/dL (which can be maintained or exceeded by blood transfusion); - Red blood cell count >= 2.0x10^9/L - Absolute neutrophil count (ANC) >=1.0x10^9/L; - Platelet count >=100x10^9/L; -Total bilirubin within normal limits; - Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase <= 2.5 times the upper limit of normal; - Creatinine <=2.0 mg/dL; and creatinine clearance >= 60 ml/min; - International normalized ratio of prothrombin time in patients who have not received anticoagulant therapy (INR) <= 1.5, partial thromboplastin time (APTT) <= 1.5 times the upper limit of normal. Patients receiving full-dose or parenteral anticoagulant therapy can enter clinical trials as long as the anticoagulant dose is stable for at least 2 weeks before entering the clinical study, and the results of the coagulation test are within the limits of local treatment; the remaining screening The laboratory inspection values ??made by the investigation must meet the relevant standards;
9. Women of childbearing age should test urine and serum HCG within 7 days before the start of treatment, and the results must be negative; male and female patients of appropriate age must use reliable methods of contraception before entering the trial, during the research process until 30 days after drug withdrawal. Reliable contraceptive methods will be adjudicated by the principal investigator or designee.

排除标准：

1.任何不稳定的系统性疾病（包括活动性感染、未得到控制的高血压、不稳定型心绞痛、最近3个月内开始发作的心绞痛、充血性心功能衰竭（≥纽约心脏病协会【NYHA】 II级）、心机梗塞（入组前6个月）、需要药物治疗的严重心律失常、肝脏，肾脏或代谢性疾病；2.2合并有不受控制神经病变（2级或以上）或精神病患者；
2.有活动性、已知或怀疑有自身免疫性疾病。有下列病症的受试者可以入选：白癜风，I型糖尿病，只需要用激素替代治疗的、自身免疫性甲状腺炎所致的残留性甲状腺功能减退，或预计没有外界因素刺激不会复发的病症；
3.以前用过抗PD-1抗体、抗PD-L1抗体、抗PD-L2抗体或抗CTLA-4抗体治疗（或作用于T细胞协同刺激或检查点通路的任何其他抗体）；
4.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，除非能够证明以前所用的抗结核治疗充分有效；
5.已知有人免疫缺陷病毒（HIV）检查阳性病史或已知有获得性免疫缺陷综合征（艾滋病）；
6.需要用免疫抑制药物治疗的合并症，或需要按具有免疫抑制作用的剂量全身或局部使用皮质类固醇的合并症；
7.既往相同部位接受过放疗导致不能接受本次大分割放疗；
8.哺乳期妇女；
9.在首次用药前2个月内进行过大手术或受严重外伤的患者；
10.对研究药物过敏；
11.其他研究者认为不适合入组的情况。

Exclusion criteria：

1. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that started within the last 3 months, congestive heart failure (>= New York Heart Association [NYHA]) ] Grade II), myocardial infarction (6 months before enrollment), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 2.2 patients with uncontrolled neuropathy (grade 2 or above) or mental illness;
2. Active, known or suspected autoimmune disease. Subjects with the following conditions can be included: vitiligo, type I diabetes, residual hypothyroidism caused by autoimmune thyroiditis only with hormone replacement therapy, or conditions that are not expected to recur without external stimulation;
3. Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell costimulation or checkpoint pathway);
4. According to chest X-ray examination, sputum examination and clinical physical examination, it is judged to have active pulmonary tuberculosis (TB) infection. Patients with a history of active pulmonary tuberculosis infection within the previous 1 year were excluded even if they had been treated. Patients with a history of active pulmonary tuberculosis infection more than 1 year ago should also be excluded unless it can be demonstrated that the previous anti-tuberculosis treatment was sufficiently effective;
5. Known positive medical history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
6. Complications requiring treatment with immunosuppressive drugs, or comorbidities requiring systemic or topical corticosteroids at doses with immunosuppressive effects;
7. Patients who have received radiotherapy at the same site in the past cannot receive this hypofractionated radiotherapy;
8. Lactating women;
9. Patients who have undergone major surgery or suffered severe trauma within 2 months before the first drug;
10. Allergic to the research drug;
11. Other researchers think that it is not suitable for inclusion.

研究实施时间：

Study execute time：

从 From 2021-09-01 00:00:00至 To 2022-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-09-01 00:00:00 至 To 2024-07-31 00:00:00

干预措施：

Interventions：

组别：

干预组1

样本量：

 75

Group：

Intervention Group 1

Sample size：

干预措施：

化疗联合PD-1/PD-L1 抑制剂序贯放疗联合PD-1/PD-L1 抑制剂

干预措施代码：

Intervention：

chemotherapy combined with PD-1/PD-L1 inhibitor sequential radiotherapy combined with PD-1/PD-L1 inhibitor

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

 成都 

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

 西南医科大学附属医院 

单位级别：

 三级甲等 

Institution
hospital：

Affiliated Hospital of Southwest Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

总生存

指标类型：

主要指标

Outcome：

overall survival, OS

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

无进展生存

指标类型：

次要指标

Outcome：

progression-free survival, PFS

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 remission 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：

安全性和耐受性

指标类型：

次要指标

Outcome：

Safety and tolerability

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

健康相关的生活质量

指标类型：

次要指标

Outcome：

health-related quality of life,HRQoL

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 岁 years
最大 Max age 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）：

单臂研究，无随机分组

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

It is a single-arm study without randomized grouping.

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）：

原始数据公开为2027年3月1日，采用excel表格或者病例记录表共享

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

Raw data was publicly available in March 1, 2027 and was shared by Excel forms or case records

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，并每周上传至研究者指定邮箱

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

Data collection and management consists of two parts. One is Case Record (CRF), the other is electronic collection, and the data is assigned to the researcher’s email every week

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-08-15 23:36:41