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：	ChiCTR2500097693
最近更新日期： Date of Last Refreshed on：	2025-02-24 16:23:28
注册时间： Date of Registration：	2025-02-24 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	罗普司亭N01用于恶性肿瘤化疗导致的血小板降低的二级预防的临床研究
Public title：	Clinical trial of Romiplostim N01 for secondary prevention of chemotherapy-induced thrombocytopenia in malignant tumors
注册题目简写：
English Acronym：
研究课题的正式科学名称：	罗普司亭N01用于恶性肿瘤化疗导致的血小板降低的二级预防的临床研究
Scientific title：	Clinical trial of Romiplostim N01 for secondary prevention of chemotherapy-induced thrombocytopenia in malignant tumors
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：	许国发	研究负责人：	许国发
Applicant：	Guofa Xu	Study leader：	Guofa Xu
申请注册联系人电话： Applicant telephone：	+86 150 9588 5130	研究负责人电话： Study leader's telephone：	+86 150 9588 5130
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：	wzlxgh@163.com	研究负责人电子邮件： Study leader's E-mail：	wzlxgh@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：	中国重庆市涪陵区高笋塘2号	研究负责人通讯地址：	中国重庆市涪陵区高笋塘2号
Applicant address：	No.2 Gaosuntang Road, Fuling District, Chongqing, China	Study leader's address：	No.2 Gaosuntang Road, Fuling District, Chongqing, 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：	重庆大学附属涪陵医院
Applicant's institution：	Chongqing University FuLing Hospital
研究负责人所在单位：	重庆大学附属涪陵医院
Affiliation of the Leader：	Chongqing University FuLing 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：	2024CDFSFLYYEC-84	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：	重庆大学附属涪陵医院伦理委员会
Name of the ethic committee：	Ethics Committee of Chongqing University FuLing Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-11-19 00:00:00
伦理委员会联系人：	李言
Contact Name of the ethic committee：	Yan Li
伦理委员会联系地址：	中国重庆市涪陵区高笋塘2号
Contact Address of the ethic committee：	No.2 Gaosuntang Road, Fuling District,Chongqing, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 139 9622 8076	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：

重庆大学附属涪陵医院

Primary sponsor：

Fuling Hospital Chongqing University

研究实施负责（组长）单位地址：

中国重庆市涪陵区高笋塘2号

Primary sponsor's address：

No.2 Gaosuntang Road, Fuling District, Chongqing, 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)：	重庆市	市(区县)：	涪陵区
Country：	China	Province：	Chongqing	City：	Fuling District
单位(医院)：	重庆大学附属涪陵医院	具体地址：	中国重庆市涪陵区高笋塘2号
Institution hospital：	Fuling Hospital Chongqing University	Address：	No.2 Gaosuntang Road, Fuling District, Chongqing, China

经费或物资来源：

企业赞助

Source(s) of funding：

Corporate sponsorship

研究疾病：

血小板减少

Target disease：

Thrombocytopenia

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：

其它

Study phase：

N/A

研究设计：

非随机对照试验

Study design：

Non randomized control

研究目的：

评估罗普司亭N01用于恶性肿瘤化疗导致的血小板降低的二级预防的有效性和安全性。

Objectives of Study：

To evaluate the efficacy and safety of Romiplostim N01 for secondary prevention of chemotherapy-induced thrombocytopenia in malignant tumors.

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) Age>=18 years old at enrollment, both males and females;
(2) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
(3) Life expectancy > 12 weeks;
(4) Malignant tumors confirmed by histology or cytology, excluding myeloid malignancies;
(5) No chemotherapy dose reduction of>=15% occurred during this chemotherapy period;
(6) Planned to perform>=2 chemotherapy sessions and the chemotherapy regimen has not been changed;
(7) The previous PLT during this chemotherapy meets the following requirements:
The lowest platelet count (PLT) after chemotherapy during the screening period (X cycle) is <50×10^9/L;
The lowest PLT value after chemotherapy during the screening period (X cycles) was>=50×10^9/L but <75×10^9/L, accompanied by high risk factors for bleeding:
1)History of previous bleeding ;
2)Previous treatment with drugs including platinum, gemcitabine, cytarabine, anthracycline, PARP inhibitors (niraparib), etc.;
3)Combination of targeted drugs that tend to cause thrombocytopenia and chemotherapeutic drugs that tend to cause thrombocytopenia;
4)Thrombocytopenia caused by bone marrow infiltration of tumor cells;
5)ECOG physical fitness score = 2 points;
6)Previous radiotherapy, especially long bones and flat bones (such as pelvis, sternum, etc.) have received radiotherapy;
(8) The function of important organs meets all of the following requirements (no blood components were infused, no cell growth factors and/or platelet-raising drugs were used within 2 weeks before the start of study treatment):
Hematology:Absolute neutrophil count (ANC)>=1.5×10^9/L;Hemoglobin>=90g/L; Platelet count>=100×10^9/L;
Liver function:Alanine aminotransferase (ALT) and aspartateaminotransferase (AST) and alkaline phosphatase (ALP)<=2.5; ×ULN;Subjects with liver metastasis or bone metastasis, ALP<= 5×ULN;Serum total bilirubin (TBil)<= 1.5 × ULN; serum albumin (ALB)>=30g/L;
Renal function: Calculated creatinine clearance (CrCl)>= 60 mL/min (CrCl calculated according to the Cockcroft-Gault formula) or serum creatinine<=1.5×ULN;
(9)Female subjects of childbearing potential (theoretically female aged 15 to 49, including unmarried, married or widowed) must have a negative serum pregnancy test within 30 days before the first use of the drug;Female subjects of childbearing age must use acceptable contraceptive methods from the screening onwards, and must agree to continue using contraceptive methods for at least 6 months after the last dose of the study drug; male subjects who have not been sterilized must use acceptable contraceptive methods from the screening onwards to at least 6 months after the last dose; the specific time to stop using contraception should be determined by the researcher;
(10)The subjects voluntarily participate in this study and are able to cooperate with treatment, regular evaluation, follow-up and other requirements related to this study, and sign the informed consent form.

排除标准：

（1）入组前<=3个月存在血栓病史。（2）入组前<=1个月接受放射治疗，或未来两个化疗周期有放疗计划。（3）入组前1周内曾使用具有调节造血功能的中草药或中成药。（4）已知异体器官移植史和异体造血干细胞移植史。（5）在首次给药前30天内进行过重大外科手术或发生严重外伤，或在首次给药后有手术计划的受试者。（6）药物滥用、酗酒或吸毒史。（7）妊娠期或哺乳期女性。（8）受试者存在未能控制良好的其他基础疾病、感染、治疗、实验室检查异常，可能会混淆研究结果，影响受试者全程参与研究，或参与研究可能不符合受试者的最佳利益。

Exclusion criteria：

(1) Subject has a history of thrombosis <=3 months before enrollment. (2) Received radiation therapy <=1 month prior to enrollment, or had a radiation plan for the next two chemotherapy cycles. (3)Use of Chinese herbal medicines or proprietary Chinese medicines that regulate hematopoietic functions within 1 week before enrollment. (4)Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. (5)Subjects who had undergone major surgical procedures or experienced severe trauma within 30 days before the first dose, or had surgery planned after the first dose. (6)History of drug abuse, alcoholism or drug abuse. (7)Pregnant or lactating female. (8)The subjects have other underlying diseases, infections, treatments, and laboratory test abnormalities that are not well controlled, which may confuse the study results and affect the subject's entire participation in the study, or participation in the study may not be in the subject's best interests.

研究实施时间：

Study execute time：

从 From 2025-03-01 00:00:00至 To 2027-02-28 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-03-01 00:00:00 至 To 2027-02-28 00:00:00

干预措施：

Interventions：

组别：	队列一（治疗组）	样本量：	30
Group：	Cohort 1(Treatment Group)	Sample size：	30
干预措施：	预防期（X+1周期）化疗结束后24-48小时接受罗普司亭N01预防治疗，起始剂量3μg/kg，每周一次，皮下注射。根据罗普司亭N01给药前PLT调整本次给药剂量： PLT<50×10^9/L，增加1-2μg/kg； PLT≥50×10^9/L但<75×109/L，增加1μg/kg； PLT≥75×10^9/L但<100×109/L，不调整剂量； PLT＞100×10^9/L，停止给药。其他为常规治疗方案。	干预措施代码：
Intervention：	During the prophylactic phase (X+1 cycle), 24-48 hours after the end of chemotherapy, roproxitim N01 prophylaxis was received, with an initial dose of 3 μg/kg, once a week, subcutaneous injection. Adjust the dose of this administration according to the pre-dose PLT of roprostim N01: PLT<50×10^9/L, increase by 1-2μg/kg; PLT ≥ 50×10^9/L but < 75×109/L, an increase of 1μg/kg; PLT ≥ 75×10^9/L but < 100×109/L, no dose adjustment; PLT > 100×10^9/L, stop administration. Others are conventional treatment options.	Intervention code：

组别：	队列二（根据队列一患者特征（化疗药物数量、既往治疗线数、既往升血小板药物使用情况）匹配入组）	样本量：	30
Group：	Cohort 2 (matched enrollment based on cohort 1 patient characteristics (number of chemotherapy drugs, number of previous lines of therapy, previous platelet-raising drug use))	Sample size：	30
干预措施：	常规治疗方案。	干预措施代码：
Intervention：	Conventional treatment options.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	重庆	市(区县)：	涪陵区
Country：	China	Province：	Chongqing	City：	Fuling District
单位(医院)：	重庆大学附属涪陵医院	单位级别：	三甲
Institution hospital：	Fuling Hospital Chongqing University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	预防期（X+1周期）D20患者PLT ＞100×10^9/L的患者比例	指标类型：	主要指标
Outcome：	The proportion of patients with PLT >100×10^9/L on D20 during the prevention period (X+1 cycle)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	预防期（X+1周期）D20患者PLT ＞75×10^9/L的患者比例	指标类型：	次要指标
Outcome：	The proportion of patients with PLT >75×10^9/L on D20 during the prevention period (X+1 cycle)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	预防期（X+1周期）患者需输血治疗的患者比例	指标类型：	次要指标
Outcome：	The proportion of patients requiring blood transfusion during the prevention period (X+1 cycle)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	观察期（X+2周期）化疗减量＞＝15%的患者比例	指标类型：	次要指标
Outcome：	The proportion of patients with chemotherapy dose reduction>=15% during the observation period (X+2 cycle)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	观察期（X+2周期）化疗延迟＞＝4天的患者比例	指标类型：	次要指标
Outcome：	The proportion of patients with chemotherapy delay >= days during the observation period (X+2 cycle)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	安全性评估：包括不良事件（AE）的发生率和严重程度、有临床意义的异常实验室检查结果	指标类型：	次要指标
Outcome：	Safety evaluation: including the incidence and severity of adverse events (AEs), and clinically significant abnormal laboratory test results	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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	18	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）：

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：
Blinding：
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	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：	病例记录表
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：	2025-02-24 16:23:16