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：	ChiCTR2500104835
最近更新日期： Date of Last Refreshed on：	2025-06-24 16:05:59
注册时间： Date of Registration：	2025-06-24 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	氟唑帕利联合替莫唑胺治疗复发性广泛期小细胞肺癌的前瞻性、单臂、多中心 II 期临床研究
Public title：	Fluzoparib combination with temozolomide in recurrent extensive-stage small cell lung cancer,a prospective, single-arm, multi- Center Phase II clinical study
注册题目简写：
English Acronym：
研究课题的正式科学名称：	氟唑帕利联合替莫唑胺治疗复发性广泛期小细胞肺癌的前瞻性、单臂、多中心 II 期临床研究
Scientific title：	Fluzoparib combination with temozolomide in recurrent extensive-stage small cell lung cancer,a prospective, single-arm, multi- Center Phase II clinical study
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：	缪继东	研究负责人：	缪继东
Applicant：	Jidong Miao	Study leader：	Jidong Miao
申请注册联系人电话： Applicant telephone：	+86 139 9008 3033	研究负责人电话： Study leader's telephone：	+86 139 9008 3033
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：	miaojidong@126.com	研究负责人电子邮件： Study leader's E-mail：	miaojidong@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：	四川省自贡市自流井区檀木林街19号	研究负责人通讯地址：	四川省自贡市自流井区檀木林街19号
Applicant address：	No. 19, Tanmulin Street, Ziliujing District, Zigong City, Sichuan Province	Study leader's address：	No. 19, Tanmulin Street, Ziliujing District, Zigong City, Sichuan Province
申请注册联系人邮政编码： Applicant postcode：	643000	研究负责人邮政编码： Study leader's postcode：	643000
申请人所在单位：	自贡市第四人民医院
Applicant's institution：	Zigong Fourth People's Hospital
研究负责人所在单位：	自贡市第四人民医院
Affiliation of the Leader：	Zigong Fourth 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：	EC-2024-072	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：	自贡市第四人民医院伦理委员会
Name of the ethic committee：	Ethics Committee of Zigong Fourth People's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-05-20 00:00:00
伦理委员会联系人：	梁亦可
Contact Name of the ethic committee：	Yike Liang
伦理委员会联系地址：	中国四川省自贡市自流井区檀木林街19号
Contact Address of the ethic committee：	No.19, Tanmulin Street, Ziliujing District, Zigong City, Sichuan Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 137 7859 7572	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：

自贡市第四人民医院

Primary sponsor：

Zigong Fourth People's Hospital

研究实施负责（组长）单位地址：

中国四川省自贡市自流井区檀木林街19号

Primary sponsor's address：

No.19, Tanmulin Street, Ziliujing District, Zigong City, Sichuan Province, 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)：	自贡市
Country：	China	Province：	Sichuan	City：	Zigong
单位(医院)：	自贡市第四人民医院	具体地址：	四川省自贡市自流井区檀木林街19号
Institution hospital：	Zigong Fourth People's Hospital	Address：	No.19, Tanmulin Street, Ziliujing District, Zigong City, Sichuan Province, China

经费或物资来源：

四川省医学会

Source(s) of funding：

Sichuan Medical Association

研究疾病：

小细胞肺癌

Target disease：

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：

单臂

Study design：

Single arm

研究目的：

观察氟唑帕利联合替莫唑胺治疗复发性广泛期小细胞肺癌的有效性与安全性。

Objectives of Study：

To observe the efficacy and safety of flazoparib combined with temozolomide in the treatment of relapsed extensimal 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

Patients with recurrent extensive small cell lung cancer who failed first-line platinum-based chemotherapy.
1.Patients with extensious-stage small cell lung cancer diagnosed by pathology, aged 18 to 75 years, who have failed first-line platinum-based chemotherapy in the past.
2.According to the efficacy evaluation Criteria for Solid Tumors (RECIST Version 1.1), there is at least one radiologically measurable lesion.
3 Eastern Cooperative Oncology Group Performance Status Score (ECOG PS) : 0-1 point.
4Laboratory indicators meet the following standards:
(1)Blood routine: Absolute neutrophil count (ANC) >=1.5 × 10^9/L; Hemoglobin >=90g/L Platelet count >=75x10^9/L;
(2) Biochemical indicators: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5 times the upper limit of normal values (ULN). If there is liver metastasis, ALT and AST<=5 times ULN. Total bilirubin (TBIL) <=1.5 times ULN; Serum creatinine <=1.5 times ULN or creatinine clearance rate >=60ml/min;
(3)Coagulation function: International normalized Ratio (INR) or prothrombin time (PT) <=1.5 times ULN.
5.Good cardiac function, with left ventricular ejection fraction (LVEF) >=50%.
6.Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after the cessation of research and treatment, and they must be non-lactating patients. Seven days before the start of administration, the pregnancy test was negative. For men, it is necessary to agree to use appropriate contraceptive methods or have undergone surgical sterilization during the trial and 8 weeks after the last administration of the trial drug.
7. The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.
8. Patients with asymptomatic brain metastases or controlled brain metastases (with stable clinical symptoms for at least 2 weeks after symptomatic treatment of brain metastases). In addition, preventive brain irradiation for patients is allowed.

排除标准：

1.病理学确诊的混合性小细胞肺癌和非小细胞肺癌。 2.首次给药前5年内诊断为小细胞肺癌之外的其他恶性肿瘤性疾病（不包括经过根治的皮肤基底细胞、皮肤鳞状上皮癌、和/或经过根治性切除的原位癌）。 3.签署知情同意书前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。 4.治疗前2周（或更长的时间，具体取决于所用药物的定义特征）接受最后一剂化疗或放疗（除姑息性治疗），患者可以在研究之前和期间接受稳定剂量的双膦酸盐治疗骨转移，只要这些药物在氟唑帕利和替莫唑胺治疗前至少4周开始。 5.参与者未停止使用以下类别的CYP3A4抑制剂，如果末次CYP3A4抑制剂在氟唑帕利和替莫唑胺治疗开始之前间隔至少7天的清除期，则可纳入。唑类抗真菌药、大环内酯类抗生素、蛋白酶抑制剂。 6.存在临床上不可控制的胸腔积液/腹腔积液（不需要引流积液或停止引流3天积液无明显增加的受试者可以入组）。 7.在开始治疗前，尚未从任何干预措施引起的毒性和/或并发症中充分恢复（即≤1级或达到基线，不包括乏力或脱发）。 8.有严重的心血管疾病，如纽约心脏病协会（NYHA）2级以上心力衰竭、不稳定型心绞痛、不稳定性心律失常、首次用药前前3个月内发生的心肌梗死或脑血管意外。 9.无法吞咽口服药物和可能干扰研究药物吸收的胃肠道疾病患者。 10.HBsAg 阳性，且外周血乙肝病毒脱氧核糖核酸（HBV DNA）滴度≥104拷贝数/ml或者≥2000 IU/ml；或HCV阳性；已知HIV阳性病史或已知的获得性免疫缺陷综合征。 11.首次用药前存在重度感染，包括但不仅限于需住院治疗的感染并发症、菌血症、重症肺炎等。 12.已知对本研究药物活性成分或辅料过敏者。 13.已知有精神疾病、酗酒、无法戒烟、吸毒或药物滥用等情况。 14.经研究者判断，受试者有其他可能导致本研究被迫中途终止的因素，如，不依从方案、其他的严重疾病（含精神疾病）需要合并治疗，有严重的实验室检查异常，伴有家庭或社会等因素，会影响到受试者的安全，或资料及样品的收集。

Exclusion criteria：

1. Pathologically confirmed mixed small cell lung cancer and non-small cell lung cancer. 2. Other malignant neoplastic diseases other than small cell lung cancer diagnosed within 5 years before the first administration (excluding radical cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radical resected carcinoma in situ). 3. Have received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the informed consent form. 4. Two weeks (or longer, depending on the defining characteristics of the drug used) before treatment, the last dose of chemotherapy or radiotherapy (except palliative treatment) was received. Patients can receive a stable dose of bisphosphonate for bone metastasis treatment before and during the study, provided that these drugs were initiated at least four weeks before the treatment of flazoparib and temozolomide. 5.Participants who did not discontinue the use of the following categories of CYP3A4 inhibitors could be included if the last CYP3A4 inhibitor had a clearance period of at least 7 days before the initiation of flazoparib and temozolomide treatment. Azole antifungal drugs, macrolide antibiotics, protease inhibitors. 6.There is clinically uncontrollable pleural effusion/peritoneal effusion (subjects who do not require drainage of the effusion or whose effusion does not increase significantly after 3 days of drainage cessation can be enrolled). 7. Before the initiation of treatment, the patient has not fully recovered from the toxicity and/or complications caused by any intervention measures (i.e., ≤ grade 1 or reaching the baseline, excluding fatigue or alopecia). 8. Have severe cardiovascular diseases, such as New York Heart Association (NYHA) grade 2 or above heart failure, unstable angina pectoris, unstable arrhythmia, myocardial infarction or cerebrovascular accident that occurred within the first 3 months before the first medication. 9. Patients with gastrointestinal diseases who are unable to swallow oral medications and who may interfere with the absorption of the studied drugs. 10. Positive for HBsAg, and the titer of hepatitis B virus deoxyribonucleic acid (HBV DNA) in peripheral blood is >=104 copies /ml or >=2000 IU/ml; Or HCV positive; Known history of HIV positivity or known acquired immunodeficiency syndrome. 11.There was a severe infection before the first medication, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc. 12. Those who are known to be allergic to the active ingredient or excipients of the drug in this study. 13. It is known that there are mental illnesses, alcohol abuse, inability to quit smoking, drug abuse or drug abuse, etc. 14. The researcher judged that the subjects had other factors that might lead to the forced termination of this study halfway, such as non-compliance with the protocol, other serious diseases (including mental disorders) requiring combined treatment, severe laboratory test abnormalities, accompanied by family or social factors that would affect the safety of the subjects, or the collection of data and samples.

研究实施时间：

Study execute time：

从 From 2025-06-01 00:00:00至 To 2029-07-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-07-01 00:00:00 至 To 2026-09-01 00:00:00

干预措施：

Interventions：

组别：	干预组	样本量：	34
Group：	Intervention group	Sample size：	34
干预措施：	氟唑帕利联合替莫唑胺	干预措施代码：
Intervention：	Fluzoparib combined with temozolomide	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	四川省	市(区县)：	贡井区
Country：	China	Province：	Sichuan	City：	Gongjing
单位(医院)：	自贡市第三人民医院	单位级别：	三甲
Institution hospital：	Zigong Third People's Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	四川省	市(区县)：	富顺县
Country：	China	Province：	Sichuan	City：	Fushun
单位(医院)：	富顺县人民医院	单位级别：	三甲
Institution hospital：	Fushun County People's Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	四川	市(区县)：	大安区
Country：	China	Province：	Sichuan	City：	Daan
单位(医院)：	大安区人民医院	单位级别：	三甲
Institution hospital：	Da 'an District People's Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	四川	市(区县)：	自流井区
Country：	China	Province：	Sichuan	City：	Ziliujin
单位(医院)：	自贡市精生卫生中心	单位级别：	三甲
Institution hospital：	Zigong Jingsheng Health Center	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	客观缓解率	指标类型：	主要指标
Outcome：	Objective remission rate, ORR	Type：	Primary 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 Ratel, 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：	无进展生存期	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：	总生存期	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：

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）：

无

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

None

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：	无
Blinding：	None
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）：	原始数据公开为2029年7月1日，使用自贡市第四人民医院EDC系统。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The original data was made public as of July 1, 2029, and is shared in EDC of Zigong N0.4 People‘s Hospital.
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)，二为电子采集上传至EDC。
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 EDC.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2025-06-24 16:05:46