ChiCTR2200063595 版本V1.1 版本创建时间2023/04/09 10:55:27 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：

 ChiCTR2200063595 

最近更新日期：

Date of Last Refreshed on：

 2022-09-13 15:22:47 

注册时间：

Date of Registration：

 2022-09-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评价伏美替尼联合贝伐珠单抗或伏美替尼单药治疗非鳞非小细胞肺癌脑转移患者有效性与安全性的临床研究

Public title：

A clinical study to evaluate the efficacy and safety of Furmonertinib combined with bevacizumab or Furmonertinib monotherapy in patients with brain metastases from non-squamous non-small cell lung cancer

注册题目简写：

无

English Acronym：

None

研究课题的正式科学名称：

一项评价伏美替尼联合贝伐珠单抗或伏美替尼单药治疗非鳞非小细胞肺癌脑转移患者有效性与安全性的临床研究

Scientific title：

A clinical study to evaluate the efficacy and safety of Furmonertinib combined with bevacizumab or Furmonertinib monotherapy in patients with brain metastases from non-squamous 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：

金伟 

研究负责人：

潘跃银 

Applicant：

Wei Jin 

Study leader：

Yueyin Pan 

申请注册联系人电话：

Applicant telephone：

 18856021648

研究负责人电话：

Study leader's
telephone：

13805695536

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：

 jw125181654@163.com

研究负责人电子邮件：

Study leader's E-mail：

 panyueyin@ustc.edu.cn

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：

安徽省合肥市蜀山区环湖东路107号

研究负责人通讯地址：

安徽省合肥市蜀山区环湖东路107号

Applicant address：

107 Huanhu Dong Lu, Hefei City, Anhui Province, China

Study leader's address：

107 Huanhu Dong Lu, Hefei City, Anhui Province, 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：

中国科学技术大学附属第一医院(安徽省肿瘤医院）

Applicant's institution：

The First Affiliated Hospital of University of Science and Technology of China （Anhui Provincial Cancer Hospital)

研究负责人所在单位：

中国科学技术大学附属第一医院(安徽省肿瘤医院）

Affiliation of the Leader：

The First Affiliated Hospital of University of Science and Technology of China （Anhui Provincial Cancer 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：

 伦审2022 第27号

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：

安徽省肿瘤医院伦理委员会

Name of the ethic committee：

Ethics Committee of Anhui Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-04-26 00:00:00

伦理委员会联系人：

钱立庭

Contact Name of the ethic committee：

Liting Qian

伦理委员会联系地址：

安徽省合肥市蜀山区环湖东路107号

Contact Address of the ethic committee：

107 Huanhu Dong Lu, Shushan District, Hefei City, Anhui Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 0551-65327725

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：

中国科学技术大学附属第一医院(安徽省肿瘤医院）

Primary sponsor：

The First Affiliated Hospital of University of Science and Technology of China （Anhui Provincial Cancer Hospital）

研究实施负责（组长）单位地址：

安徽省合肥市蜀山区环湖东路107号

Primary sponsor's address：

107 Huanhu Dong Lu, Shushan District, Hefei City, Anhui 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)：

安徽

市(区县)：

合肥市

Country：

China

Province：

Anhui

City：

Hefei

单位(医院)：

中国科学技术大学附属第一医院

具体地址：

安徽省合肥市蜀山区环湖东路107号

Institution
hospital：

The First Affiliated Hospital of University of Science and Technology of China

Address：

107 Huanhu Dong Lu, Hefei, Anhui, China

经费或物资来源：

上海艾力斯医药科技股份有限公司

Source(s) of funding：

Shanghai Allist Pharmaceuticals Co., Ltd.

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：

 II期临床试验 

Study phase：

2

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

评估高剂量伏美替尼单药、高剂量伏美替尼联合贝伐珠单抗在EGFR突变阳性非鳞非小细胞肺癌脑转移患者中的有效性  

Objectives of Study：

To evaluate the efficacy of high-dose Furmonertinib alone or high-dose Furmonertinib combined with bevacizumab in patients with brain metastases from EGFR mutation-positive non-squamous 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：

与疾病有关的入选标准：
1) 目标人群为经组织学或细胞学确诊的晚期非鳞非小细胞肺癌 [美国癌症联合委员会 (AJCC) 第8版TNM分期为IV期]；经中心实验室检测组织学或细胞学标本证实为存在EGFR外显子19缺失突变（19DEL）或外显子21 L858R点突变（L858R），以上突变可单独存在或共同存在；
2) 对于脑膜转移患者：通过脑脊液（CSF ）细胞学确诊，或经2名影像学专家诊断为脑膜转移，不需要可测量的脑实质或颅外病灶;
3) 对于具有可客观测量病灶的脑转移患者但没有脑膜转移的患者：按照实体瘤疗效评价标准(RECIST 1.1)，受试者至少有一处既往未经过照射，也没有在筛选期接受过组织活检，可准确测量的CNS转移病灶；
4) 患者在研究药物治疗开始前未接受过针对晚期/转移性非小细胞肺癌的系统性抗肿瘤治疗，包括标准化疗、生物治疗、靶向治疗、免疫治疗、或者试验性药物治疗（三代EGFR TKI,贝伐珠单抗）；接受过辅助治疗或新辅助治疗（化疗和/或放疗）的患者，如果治疗后6个月内没有进展，允许入组；对于接受过局部治疗(放疗或胸膜腔灌注治疗) 的患者，如果局部治疗范围内的病灶为非靶病灶，允许入组;

一般入选标准：
1) 取得患者或其法定代理人签署的知情同意书；
2) 年龄≥18岁；
3) ECOG 体力状况评分为 0-2 并且在入组之前 2 周没有恶化；
4) 预期寿命≥ 12 周;
5) 能够依从研究方案及随访程序的要求，并能接受口服药物治疗。
6) 可提供血液样本、脑脊液标本并签署遗传研究的书面知情同意书。

Inclusion criteria

Disease related inclusion criteria:
1) The target population was advanced non-squamous non-small cell lung cancer (AJCC 8th TNM stage IV) confirmed by histology or cytology. EGFR exon 19 deletion mutation (19DEL) or exon 21 L858R point mutation (L858R) were confirmed by histological or cytological examination of the central laboratory, and these mutations could exist alone or together;
2) For patients with meningeal metastases: Confirmed by cerebrospinal fluid (CSF) cytology, or by two Radiological imaging specialists, meningeal metastases do not require measurable parenchymal or extracranial lesions;
3) For patients with brain metastases that can be objectively measured but without meningeal metastases: subjects have at least one CNS metastases that can be accurately measured according to the Response Evaluation criteria for solid tumors (RECIST 1.1) that were not previously irradiated and did not undergo tissue biopsy during the screening period;
4) Patients had not received systemic antitumor therapy for advanced/metastatic NSCLC, including standard chemotherapy, biotherapy, targeted therapy, immunotherapy, or investigational drug therapy (third-generation EGFR TKI, bevacizumab) before study drug therapy was initiated; Patients who had received adjuvant or neoadjuvant therapy (chemotherapy and/or radiotherapy) and did not progress within 6 months after treatment were allowed to enroll; Patients who had received local therapy (radiotherapy or pleural cavity perfusion therapy) were allowed to enroll if the lesion within the range of local therapy was non-target;

General inclusion criteria:
1) Informed consent signed by the patient or his legal representative;
2) Age above 18 years;
3) ECOG score of 0-2 and no deterioration 2 weeks before enrollment;
4) Life expectancy ≥ 12 weeks;
5) Able to comply with the study protocol and follow-up procedures, and able to receive oral medication;
6) Blood samples and cerebrospinal fluid samples can be provided and written informed consent for genetic research can be signed.

排除标准：

1) 非肺腺癌患者，包括肺鳞癌或混合型组织学类型等；
2) 已知对于伏美替尼的有活性或无活性辅料或与伏美替尼有类似的化学结构或类别的药物的超敏反应史；或对于贝伐珠单抗的有活性或无活性辅料或与贝伐珠单抗有类似结构药物的超敏反应史；
3) 有确证的EGFR 外显子20插入突变；
4) 接受过以下任何治疗的患者：
接受过胸膜腔内灌注治疗的患者,需在胸水稳定后 28 天及以上才可入组;
首剂研究药物给药前 28 天内接受过大手术；
首次研究药物给药前 28 天内，接受过照射区域≥30%骨髓或广范围的放疗；首次研究药物给药前 14 天内接受过局部放
疗或针对骨转移的姑息性放疗;
首次给药前 7 天内接受过 CYP3A4 强效抑制剂或强效诱导剂，或研究期间需要继续接受这些药物治疗的患者;
首次给药前7天内接受过以抗肿瘤为适应症的中药及中成药制剂，或研究期间需要继续接受这些药物治疗的患者；
正在接受已知可延长 QTc 间期或可能导致尖端扭转性室性心动过速的药物治疗，且研究期间需要继续接受这些药物治疗
的患者；
首次给药前，停用其他临床试验性药物的时间未满 5个半衰期或2个月内（以较长者为准);
5) 既往接受过针对晚期/转移性非小细胞肺癌的系统性抗肿瘤治疗（如标准化疗、靶向治疗、生物治疗、免疫治疗等）的患者，其中新辅助及辅助治疗请参照入组标准7；
6) 近5年罹患其他恶性肿瘤或有其他恶性肿瘤病史, 已经得到有效控制的皮肤基底细胞癌、宫颈原位癌和乳腺导管原位癌除外;
7) 近期活动性消化性疾病，如十二指肠溃疡，溃疡性结肠炎、回肠炎等，肠穿孔，肠瘘，或其他有研究者酌情规定的可能导致胃肠道出血或穿孔的情况；或有难治性恶心呕吐，慢性胃肠道疾病，无法吞咽研究药物，或既往行大肠癌切除术等妨碍伏美替尼充分吸收的情况；
8) 通过裂隙灯评价进行眼科检查确诊的角膜损伤的任何证据;
9) 间质性肺病病史、药物引起的间质性肺病、需要类固醇治疗的放射性肺炎；
10) 存在任何重度或不受控制的全身性疾病的证据，包括未控制的高血压、糖尿病和活动性出血等，研究者认为任何不利于患者参与研究或破坏方案的依从性，或包括未控制的乙型肝炎、丙型肝炎和人类免疫缺陷病毒（HIV）在内的活动性感染；
11) 缺乏足够的骨髓储备或器官功能;
12) QT延长或任何临床重要心律异常;
13) 研究者判定不能参加本研究的患者，如大概率无法遵守研究章程、约束和要求的患者；或研究者酌情判断的其他情况；
14) 妊娠或哺乳；

Exclusion criteria：

1) Patients with non-lung adenocarcinoma, including lung squamous cell carcinoma or mixed histological type;
2) History of hypersensitivity to active or inactive excipients of investigational product (IP) or drugs with a similar chemical structure or class to investigational product (IP);
3) Confirmed EGFR 20 exon insertion mutations at any time after the initial diagnosis;
4) Patient who receive prior treatment including any of the following:
Any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI);
The patients who have received intrapleural perfusion therapy can only be enrolled 28 days or more after
the pleural effusion is stable;
Major surgery within 4 weeks of the first dose of investigational product (IP);
Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4
weeks of the first dose of IP;
CYP3A4 strong inhibitor or strong inducer is used within 7 days prior to the first dose, or need to
receive these drugs during the study period;
Traditional Chinese medicine and traditional Chinese medicine preparations with anti-tumor as indications
and with adjuvant treatment of tumor is used within 7 days prior to the first dose, or need to receive
these drugs during the study period;
Patients who are receiving drugs known to prolong QTc interval or may cause torsade de pointe and need to
continue to receive these drugs during the study period;
The time from the treatment with any other investigational product or its analogue to the first dose does
not exceed 5 half-lives of the drug or 14 days, whichever is longer;
5) Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiation including chemotherapy, biologic therapy, target therapy, immunotherapy, or any investigational drug;
6) Diagnosed other malignant tumors or had a history of other malignant tumors in last 5 years, except for skin basal cell carcinoma, cervical carcinoma in situ and breast ductal carcinoma in situ which have been effectively controlled;
7) Recent active digestive diseases such as duodenal ulcer, ulcerative colitis, ileitis, intestinal perforation, intestinal fistula, or other conditions that may cause gastrointestinal bleeding or perforation as the researchers may prescribe. Or refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of furmonertinib;
8) Any evidence of corneal injury confirmed by ophthalmic examination using slit lamp evaluation;
9) Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active Interstitial Lung Disease;
10) Any evidence of severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, any disease that the investigator considered to be detrimental to the patient's participation in the study or to adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Screening for chronic diseases is not required;
11) Inadequate bone marrow reserve or organ function;
12) QT prolongation or any clinically important abnormalities in rhythm;
13) Patients who were deemed unable to participate in the study by the investigator, such as those with a high probability of failing to comply with the study protocol, constraints, and requirements; Or other circumstances at the discretion of the investigator;
14) Pregnancy or lactation.

研究实施时间：

Study execute time：

从 From 2022-09-12 00:00:00至 To 2025-10-17 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-09-12 00:00:00 至 To 2023-12-31 00:00:00

干预措施：

Interventions：

组别：

伏美替尼组

样本量：

 20

Group：

Furmonertinib Group

Sample size：

干预措施：

伏美替尼

干预措施代码：

Intervention：

Furmonertinib

Intervention code：

组别：

伏美替尼联合贝伐珠单抗组

样本量：

 20

Group：

Furmonertinib combined with bevacizumab Group

Sample size：

干预措施：

伏美替尼联合贝伐珠单抗

干预措施代码：

Intervention：

Furmonertinib combined with bevacizumab

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

  

Country：

China

Province：

Anhui

City：

单位(医院)：

 中国科学技术大学附属第一医院（安徽省肿瘤医院） 

单位级别：

 三级甲等 

Institution
hospital：

The First Affiliated Hospital of University of Science and Technology of China

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

  

Country：

China

Province：

Anhui

City：

单位(医院)：

 安徽医科大学第一附属医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Affiliated Hospital of Anhui Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

  

Country：

China

Province：

Anhui

City：

单位(医院)：

 安徽省胸科医院 

单位级别：

 三级甲等 

Institution
hospital：

Anhui Chest Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

  

Country：

China

Province：

Anhui

City：

单位(医院)：

 安徽医科大学第二附属医院 

单位级别：

 三级甲等 

Institution
hospital：

The Second Affiliated Hospital of Anhui Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

  

Country：

China

Province：

Anhui

City：

单位(医院)：

 蚌埠医学院第一附属医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Affiliated Hospital of Bengbu Medical College

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

总体无进展生存期

指标类型：

主要指标

Outcome：

Overall Progression-free survival

Type：

Primary indicator

测量时间点：

从接受第一次研究药物开始到到出现客观疾病进展或死亡(任何原因)的时间

测量方法：

研究者根据RECIST 1.1评估

Measure time point of outcome：

Defined as the time from the beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression).

Measure method：

Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

指标中文名：

颅内无进展生存期

指标类型：

次要指标

Outcome：

CNS progression-free survival

Type：

Secondary indicator

测量时间点：

从接受第一次研究药物开始到出现颅内客观疾病进展或死亡(任何原因)的时间

测量方法：

研究者根据RECIST 1.1评估

Measure time point of outcome：

is defined as the time from beginning of study treatment until the date of CNS system objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.

Measure method：

Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

指标中文名：

颅外无进展生存期

指标类型：

次要指标

Outcome：

extracranial progression-free survival

Type：

Secondary indicator

测量时间点：

从接受第一次研究药物开始到出现颅外客观疾病进展或死亡(任何原因)的时间

测量方法：

研究者根据RECIST 1.1评估

Measure time point of outcome：

PFSe(extracranial progression-free survival ) is defined as the time from beginning of study treatment until the date of extracranial system objective disease progression or death

Measure method：

Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

指标中文名：

总体疾病客观缓解率

指标类型：

次要指标

Outcome：

Overall Objective response rate

Type：

Secondary indicator

测量时间点：

到疾病进展的整个研究过程中观察到的达到完全缓解(CR)或部分缓解(PR)受试者的比例

测量方法：

研究者根据RECIST 1.1评估

Measure time point of outcome：

Defined as the number (%) of patients with response of Complete Response or Partial Response. Data obtained from the first dose of study treatment up until progression, will be included in the assessment of Objective Response Rate.

Measure method：

Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

指标中文名：

中枢神经系统疾病客观缓解率

指标类型：

次要指标

Outcome：

CNS Objective response rate

Type：

Secondary indicator

测量时间点：

到中枢神经疾病进展的整个研究过程中观察到的达到完全缓解(CR)或部分缓解(PR)受试者的比例

测量方法：

研究者根据RECIST 1.1评估

Measure time point of outcome：

Defined as the number (%) of patients with response of Complete Response or Partial Response. Data obtained from the first dose of study treatment up until CNS progression, will be included in the assessment of Objective Response Rate.

Measure method：

Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

指标中文名：

颅外疾病客观缓解率

指标类型：

次要指标

Outcome：

Extracrania Objective response rate

Type：

Secondary indicator

测量时间点：

到颅外系统疾病进展的整个研究过程中观察到的达到完全缓解(CR)或部分缓解(PR)受试者的比例

测量方法：

研究者根据RECIST 1.1评估

Measure time point of outcome：

Defined as the number (%) of patients with response of Complete Response or Partial Response. Data obtained from the first dose of study treatment up until Extracrania system disease progression, will be included in the assessment of Objective Response Rate.

Measure method：

Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

指标中文名：

总体疾病控制率

指标类型：

次要指标

Outcome：

Overall Disease control rate

Type：

Secondary indicator

测量时间点：

DCR的定义为发生 CR+PR+疾病稳定(SD)(持续时间≥6 周)的受试者比例

测量方法：

研究者根据RECIST 1.1评估

Measure time point of outcome：

DCR was defined as the percentage of subjects who have a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the Investigator (duration ≥ 6 weeks).

Measure method：

Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

指标中文名：

中枢神经系统疾病控制率

指标类型：

次要指标

Outcome：

CNS 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：

颅外疾病控制率

指标类型：

次要指标

Outcome：

Extracranial 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：

总生存期

指标类型：

次要指标

Outcome：

Over Survival

Type：

Secondary indicator

测量时间点：

从接受第一次研究药物开始到死亡的时间

测量方法：

KM 生存曲线

Measure time point of outcome：

Overall survival is defined as the time from beginning of study treatment until death due to any cause.

Measure method：

KM survival curve

指标中文名：

安全性

指标类型：

副作用指标

Outcome：

Safety

Type：

Adverse events

测量时间点：

测量方法：

CTCAE 5.0

Measure time point of outcome：

Measure method：

CTCAE 5.0

指标中文名：

评估基线、治疗中、进展时CSF和外周血标本ctDNA的基因谱一致性和变化及其与疗效的相关性

指标类型：

附加指标

Outcome：

To evaluate the genetic profile consistency and changes of ctDNA in CSF and peripheral blood samples at baseline, during treatment, and during progression, and their correlation with efficacy

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗6周时评估 CSF 和血浆样品中的伏美替尼浓度及其与疗效的相关性；

指标类型：

附加指标

Outcome：

The concentrations of Furmonertinib in CSF and plasma samples and their correlation with efficacy were evaluated at 6 weeks of treatment

Type：

Additional 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：

组织

组织：

肺

Sample Name：

Tissue

Tissue：

Lung

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

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：

标本中文名：

脑脊液

组织：

Sample Name：

CSF Cerebrospinal fluid

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

尿

组织：

Sample Name：

Urine

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 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，开放标签

Blinding：

Open label

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）：

原始数据将于试验完成后6个月（预计为2026年2月）上传中国临床试验注册中心，网址：http://www.chictr.org.cn/searchproj.aspx

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

IPD would be shared within six months after trial complete (expected to Feb 2026) in Chinese Clinical Trial Registry (http://www.chictr.org.cn/searchproj.aspx)

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：

本研究将采用病例报告表（CRF）进行研究数据的采集与管理。

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

Case Record Form will be using for data collection and management in this study.

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：

  2022-09-13 00:35:45