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：	ChiCTR2400087229
最近更新日期： Date of Last Refreshed on：	2024-07-23 11:06:23
注册时间： Date of Registration：	2024-07-23 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	沙利度胺预防卡瑞利珠单抗治疗晚期非小细胞肺癌诱发的相关不良反应的真实世界研究
Public title：	A real-world study of thalidomide for the prevention of adverse reactions associated with carilizumab-induced treatment of advanced non-small cell lung cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	沙利度胺预防卡瑞利珠单抗治疗晚期非小细胞肺癌诱发的相关不良反应的真实世界研究
Scientific title：	A real-world study of thalidomide for the prevention of adverse reactions associated with carilizumab-induced treatment of advanced 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：	孟自力	研究负责人：	孟自力
Applicant：	Zili Meng	Study leader：	Zili Meng
申请注册联系人电话： Applicant telephone：	+86 13952399232	研究负责人电话： Study leader's telephone：	+86 13952399232
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：	mzl0807@126.com	研究负责人电子邮件： Study leader's E-mail：	mzl0807@126.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：	江苏省淮安市淮阴区黄河西路1号	研究负责人通讯地址：	江苏省淮安市淮阴区黄河西路1号
Applicant address：	1 Huanghe West Road, Huaiyin District, Huai'an City, Jiangsu Province	Study leader's address：	1 Huanghe West Road, Huaiyin District, Huai'an City, Jiangsu Province
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：	南京医科大学附属淮安第一医院
Applicant's institution：	Huai'an First Hospital Affiliated to Nanjing Medical University
研究负责人所在单位：	淮安市第一人民医院
Affiliation of the Leader：	Huai'an First 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：	KY-2024-043-02	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：	淮安市第一人民医院医学伦理委员会
Name of the ethic committee：	Huai 'an First People's Hospital Medical Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2024-05-09 00:00:00
伦理委员会联系人：	李浩
Contact Name of the ethic committee：	Li Hao
伦理委员会联系地址：	江苏省淮安市淮阴区黄河西路1号
Contact Address of the ethic committee：	1 Huanghe West Road, Huaiyin District, Huai'an City, Jiangsu Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 517 84936880	伦理委员会联系人邮箱： Contact email of the ethic committee：	hasyyll@163.com

研究实施负责（组长）单位：

淮安市第一人民医院

Primary sponsor：

Huai'an First People's Hospital

研究实施负责（组长）单位地址：

江苏省淮安市淮阴区黄河西路1号

Primary sponsor's address：

1 Huanghe West Road, Huaiyin District, Huai'an City, Jiangsu Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	淮安市第一人民医院	具体地址：	江苏省淮安市淮阴区黄河西路1号
Institution hospital：	Huai'an First People's Hospital	Address：	1 Huanghe West Road, Huaiyin District, Huai'an City, Jiangsu Province

经费或物资来源：

自筹

Source(s) of funding：

self-finance

研究疾病：

晚期非小细胞肺癌

Target disease：

Advanced 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：

IV期临床试验

Study phase：

4

研究设计：

单臂

Study design：

Single arm

研究目的：

本研究为前瞻性、单中心、开放、单臂研究，旨在评价沙利度胺预防免疫检查点抑制剂治疗晚期非小细胞肺癌时诱发的相关不良反应的有效性和安全性。

Objectives of Study：

This is a prospective, single-centre, open, single-arm study to evaluate the efficacy and safety of thalidomide for the prevention of adverse reactions associated with immune checkpoint inhibitors induced in the treatment of 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：

Inclusion criteria

1. aged 18-75 years (inclusive);
2. histologically or cytologically confirmed stage IV non-small cell lung cancer (according to AJCC 8th edition);
3. at least 1 measurable lesion, according to RECIST v1.1 criteria;
4. no systemic systemic therapy for advanced/metastatic disease;
5. physical status score (ECOG PS score): 0 -1 point;
6. Expected survival ≥ 6 months;
7. Negative for EGFR or ALK mutation;
8. No active brain metastasis;
9. Good function of major organs, i.e., the relevant examination indexes meet the following requirements in the 14 days prior to the enrolment: erythropoietin ≥ 90 g/L (no blood transfusion in 14 days); neutrophil count > 1.5 × 109/L; platelet count ≥ 100 × 109/L; total bilirubin Total bilirubin ≤ 1.5 × ULN (upper limit of normal); blood alanine aminotransferase (ALT) or blood alanine transaminase (AST) ≤ 2.5 × ULN; if liver metastases are present, ALT or AST ≤ 5 × ULN; endogenous creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula); cardiac Doppler ultrasound: left ventricular ejection fraction (LVEF) ≥ 50%;
10. Women of childbearing potential must have a negative serum pregnancy study within 7 days prior to first dose. Female subjects of childbearing potential and male subjects whose partner is a woman of childbearing potential must agree to use a highly effective method of contraception for the duration of the study and for 180 days after the last administration of study drug. 
11. understand the steps and content of the study and voluntarily sign a written informed consent form.

排除标准：

1.诊断为其他病理组织学类型的非小细胞肺癌患者，包括鳞腺混合癌患者、含小细胞肺癌成份的NSCLC患者。 2.已知EGFR突变或ALK阳性患者。 3.存在活动性中枢神经系统（CNS）转移的患者。如果患者的CNS转移能够充分治疗，如临床稳定（MRI检测）已维持至少4周，并且患者的神经系统等临床症状能够在首次用药前至少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，患者如果使用皮质类固醇类激素治疗相关临床症状，接受剂量稳定或逐渐降低的≤ 10 mg/天的泼尼松（或等价物）至少2周方可参加研究，否则不能入组。 4.患有活跃的、已知的或怀疑患有自身免疫性疾病的患者。接受稳定剂量胰岛素治疗的I型糖尿病患者、只需要激素替代治疗的甲状腺功能减退患者、以及不需要系统治疗且在筛查期前一年内没有急性恶化的皮肤病(如湿疹、白癜风等） 5.患有先天或后天免疫功能缺陷，如人类免疫缺陷病毒（HIV）感染者； 6.患有以下控制不佳的传染病：活动性乙型病毒性肝炎（HBsAg阳性且HBV DNA ≥ 500 IU/ml或1000 copies/ml）或丙型病毒性肝炎（丙肝抗体阳性且HCV-RNA 高于分析方法的检测下限）；活动性结核或目前正在接受抗结核治疗； 7.既往或现在有特发性肺纤维化、间质性肺炎、尘肺、放射性肺炎、组织性肺炎(如支气管炎、闭塞性血管炎)、药物性肺炎、CT检查中的活动性肺炎或肺功能严重受损的客观证据； 8.心脏功能和疾病符合下述情况之一，研究者认为具有临床意义，明显异常而不适合入组本研究的心律失常，包括但不限于完全性左束支传导异常，II度房室传导阻滞；12导联心电图（ECG）测量，QTc间期男性≥ 450 ms、女性≥ 470 ms ；美国纽约心脏学会（NYHA）分级≥ 3级心功能不全或心脏彩超检查：左室射血分数（LVEF）< 50% ；筛选前1年内发生过心肌梗死； 9.入组前4周内发生过严重感染（CTCAE > 2级），如需治疗的感染并发症、菌血症、重症肺炎等；首次使用药物前2周内存在感染的症状和体征需要口服或静脉使用抗生素治疗（不包括预防性使用抗生素的情况）由于感染引起的需要全身性使用抗生素的患者； 10.诊断为免疫缺陷或研究入组前7天内正在接受与肿瘤治疗非直接相关的全身性糖皮质激素治疗或任何其他形式的免疫抑制疗法；允许使用生理剂量的糖皮质激素（≤ 10 mg/天的强的松或等效药物）； 11.入组前≤ 5年并发其他恶性肿瘤，可以充分治疗的宫颈原位癌、基底细胞或鳞状上皮细胞皮肤癌、根治术后的局部前列腺癌、根治术后的导管原位癌除外； 12.入组前4周内或计划在本研究期间接受大手术（不包括诊断性的外科手术）； 13.入组前4周内接种过或计划在研究期间接种活疫苗； 14.酒精依赖者或近1年内有吸毒或药物滥用史； 15.已知有明确的神经或精神障碍，如癫痫、痴呆症，或存在外周神经系统障碍者； 16.已知有异体器官移植史或异体造血干细胞移植史； 17.怀孕或者哺乳期妇女；有生育能力的受试者不愿或无法采取有效的避孕措施者； 18.已知对研究药物或辅料过敏； 19.签署ICF前4周内曾接受其它任何试验药物治疗或参加过另一项干预性临床研究； 20.根据研究者的判断，患有可能混淆研究结果、干扰患者参与研究程序或不符合患者参加研究最佳利益的任何疾病、治疗或实验室异常的患者。

Exclusion criteria：

1. patients diagnosed with other pathohistological types of non-small cell lung cancer, including patients with mixed squamous adenocarcinoma and patients with NSCLC containing small cell lung cancer components. 2. Patients with known EGFR mutations or ALK positivity. 3. Patients with active central nervous system (CNS) metastases. Patients may be enrolled in the study if their CNS metastases can be adequately treated, e.g., clinical stability (as detected by MRI) has been maintained for at least 4 weeks and the patient's clinical symptoms, such as neurological, are able to return to baseline levels at least 2 weeks prior to the first dose of medication (with the exception of residual signs or symptoms related to CNS treatment). In addition, patients who are using corticosteroids to treat associated clinical symptoms and who have received a stable or tapering dose of ≤ 10 mg/day of prednisone (or equivalent) for at least 2 weeks may be enrolled in the study, otherwise they may not be enrolled. 4. patients with active, known or suspected autoimmune disease. Patients with type I diabetes mellitus treated with stable doses of insulin, patients with hypothyroidism requiring only hormone replacement therapy, and skin diseases (e.g., eczema, vitiligo, etc.) that do not require systemic therapy and have not acutely worsened in the year prior to the Screening Period 5. Patients with congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection; 6. have the following poorly controlled infectious diseases: active viral hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU/ml or 1000 copies/ml) or viral hepatitis C (Hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the analysing method); 1.active tuberculosis or currently receiving anti-tuberculosis treatment; 7. previous or current idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, histopneumonitis (e.g. bronchiolitis, occlusive vasculitis), drug-induced pneumonitis, active pneumonia on CT scan, or objective evidence of severely impaired lung function; 8. Cardiac dysrhythmias with one of the following cardiac functions and diseases that are considered clinically significant by the investigator, clearly abnormal and inappropriate for enrolment in this study, including but not limited to complete left bundle branch conduction abnormality, second degree atrioventricular block; 12-lead electrocardiogram (ECG) measurements with a QTc interval of ≥ 450 ms in men and ≥ 470 ms in women; American New York Heart Association (NYHA) Classification ≥ Grade 3 cardiac insufficiency or cardiac ultrasound: left ventricular ejection fraction (LVEF) < 50%; myocardial infarction within 1 year prior to screening; 9. Severe infections (CTCAE > grade 2) that occurred within 4 weeks prior to enrolment, such as infectious complications requiring treatment, bacteraemia, severe pneumonia, etc.; signs and symptoms of infections requiring oral or intravenous antibiotic treatment within 2 weeks prior to the first administration of the medication (excluding prophylactic use of antibiotics) Patients requiring systemic use of antibiotics due to infections; 10. diagnosis of immunodeficiency or receiving systemic glucocorticoid therapy not directly related to oncological treatment or any other form of immunosuppressive therapy within 7 days prior to study entry; physiological doses of glucocorticosteroids (≤ 10 mg/day of prednisone or equivalent) are permitted 11. ≤ 5 years prior to enrolment for concurrent other malignancies, except adequately treatable carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localised prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery; 12. major surgery (excluding diagnostic surgery) within 4 weeks prior to enrolment or planned during the study period; 13. having received a live vaccine within 4 weeks prior to enrolment or planning to receive a live vaccine during the study; 14. alcohol dependent or history of drug or substance abuse within the last 1 year; 15. known to have a definite neurological or psychiatric disorder such as epilepsy, dementia, or the presence of peripheral neurological deficits; 16. known history of allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation; 17. pregnant or lactating women; subjects of childbearing potential who are unwilling or unable to use effective contraception; 18. known allergy to the study drug or excipients; 19. have been treated with any other experimental drug or participated in another interventional clinical study within 4 weeks prior to signing the ICF; 20. patients who, in the investigator's judgement, suffer from any disease, treatment or laboratory abnormality that could confound the results of the study, interfere with the patient's participation in the study procedures, or is not in the patient's best interest to participate in the study.

研究实施时间：

Study execute time：

从 From 2024-08-01 00:00:00至 To 2029-03-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-08-01 00:00:00 至 To 2026-08-01 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	100
Group：	test group	Sample size：	100
干预措施：	沙利度胺：口服给药，2粒/次（50 mg/粒），每日1次，餐后至少1小时后和/或睡前服用，连续服药。	干预措施代码：
Intervention：	Thalidomide: Oral administration, 2 capsules/dose (50 mg/capsule), once daily, at least 1 hour after meals and/or at bedtime, continuous.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	淮安市第一人民医院	单位级别：	三级甲等
Institution hospital：	Huai'an First People's Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	治疗相关的不良事件（AE）发生率	指标类型：	主要指标
Outcome：	Incidence of treatment-related adverse events (AEs)	Type：	Primary indicator
测量时间点：	每周期d1	测量方法：	相关检查
Measure time point of outcome：	d1 per cycle	Measure method：	relevant inspections

指标中文名：	无进展生存期	指标类型：	次要指标
Outcome：	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：	总生存期	指标类型：	次要指标
Outcome：	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：	疾病控制率	指标类型：	次要指标
Outcome：	DCR	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：	ORR	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：	无	组织：
Sample Name：	NA	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	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）：

不适用

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

N/A

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：	无
Blinding：	None

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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	none
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：	CRF
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2024-07-23 11:06:14