Chinese Clinical Trial Register (ChiCTR) - The world health organization international clinical trials registered organization registered platform

注册号： Registration number：	ChiCTR2100054167
最近更新日期： Date of Last Refreshed on：	2022-11-06 23:00:04
注册时间： Date of Registration：	2021-12-10 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	一项评估奥希替尼联合铂类+培美曲塞化疗一线治疗携带罕见表皮生长因子受体突变（EGFRm）的复发性或局部晚期或转移性非小细胞肺癌（NSCLC）患者疗效和安全性的开放标签、单臂、多中心、探索性II 期研究
Public title：	The Efficacy and Safety of Osimertinib with Platinum plus Pemetrexed Chemotherapy, as First-Line Treatment in Recurrent or Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients with Uncommon Epidermal Growth Factor Receptor Mutations (EGFRm): A Phase II, Open Label, Single Arm, Multicenter, Exploratory
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项评估奥希替尼联合铂类+培美曲塞化疗一线治疗携带罕见表皮生长因子受体突变（EGFRm）的复发性或局部晚期或转移性非小细胞肺癌（NSCLC）患者疗效和安全性的开放标签、单臂、多中心、探索性II 期研究
Scientific title：	The Efficacy and Safety of Osimertinib with Platinum plus Pemetrexed Chemotherapy, as First-Line Treatment in Recurrent or Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients with Uncommon Epidermal Growth Factor Receptor Mutations (EGFRm): A Phase II, Open Label, Single Arm, Multicenter, Exploratory
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：	崔然然	研究负责人：	卢铀
Applicant：	Cui Ranran	Study leader：	Lu You
申请注册联系人电话： Applicant telephone：	+86 15346553669	研究负责人电话： Study leader's telephone：	+86 18980601763
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：	cui.ranran@astrazeneca.com	研究负责人电子邮件： Study leader's E-mail：	radyoulu@hotmail.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：	上海市浦东新区亮景路199号	研究负责人通讯地址：	四川省成都市武侯区国学巷37号
Applicant address：	199 Liangjing Road, Pudong New Area, Shanghai	Study leader's address：	37 Guoxue Lane, Wuhou District, Chengdu, Sichuan
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：	阿斯利康投资（中国）有限公司
Applicant's institution：	AstraZeneca Investment (China) Co., Ltd.
研究负责人所在单位：	四川大学华西医院
Affiliation of the Leader：	West China Hospital of Sichuan University

是否获伦理委员会批准：	是/Yes
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2021年临床试验（西药）审（157）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：	四川大学华西医院临床试验伦理审查委员会
Name of the ethic committee：	Ethics Committee of West China Hospital of Sichuan University
伦理委员会批准日期： Date of approved by ethic committee：	1990-01-01 00:00:00
伦理委员会联系人：	韩玉榕/赵芸芸
Contact Name of the ethic committee：	Han Yurong, Zhao Yunyun
伦理委员会联系地址：	四川省成都市武侯区国学巷37号
Contact Address of the ethic committee：	37 Guoxue Lane, Wuhou District, Chengdu, Sichuan
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：

四川大学华西医院

Primary sponsor：

West China Hospital of Sichuan University

研究实施负责（组长）单位地址：

四川省成都市武侯区国学巷37号

Primary sponsor's address：

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	阿斯利康投资（中国）有限公司	具体地址：	张江高科技园区亮景路199号
Institution hospital：	AstraZeneca Investment (China) Co., Ltd.	Address：	199 Liangjing Road, Zhangjiang High-Technology Park

经费或物资来源：

阿斯利康投资（中国）有限公司

Source(s) of funding：

AstraZeneca Investment (China) Co., Ltd.

Target disease：

Uncommon EGFRm NSCLC

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：

1. 主要目的：描述奥希替尼联合铂类药物+培美曲塞作为一线治疗的疗效信号； 2. 次要目的：进一步描述奥希替尼联合铂类药物+培美曲塞作为一线治疗的疗效信号；描述奥希替尼联合铂类药物+培美曲塞作为一线治疗的安全性和耐受性。

Objectives of Study：

1. To describe theefficacy signals of osimertinib with platinum plus pemetrexed as first-line treatment; 2. To further describe the efficacy signals of osimertinib with platinum plus pemetrexed as first-line treatment; to describe the safety and tolerability of osimertinib with platinum plus pemetrexed as first-line treatment.

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. 能够签署知情同意书，并对知情同意书（ICF）和本次研究方案中列出的要求和限制表示依从。
2. 在任何强制性研究特定程序、采样以及分析开始前，必须提供已签字并签署日期的书面知情同意书。
3. 年龄≥18岁的男性或女性患者。
4. 病理学确诊为非鳞状NSCLC。
5. 新诊断患有局部晚期（临床IIIB期、IIIC期）或转移性NSCLC（临床IVA期或IVB期），或复发性NSCLC（根据国际肺癌研究协会[IASLC]胸部肿瘤分期手册[第8版]），且不适合接受根治性手术或放疗。
6. 根据中国监管部门批准的认证实验室的肿瘤组织或血浆的ARMS或Super-ARMS或NGS检测结果，肿瘤至少携带4种罕见EGFR突变（G719X/L861Q/S768I/T790M）中的一种（单一突变或复合突变），但不包括其他EGFR突变（含ex19del/L858R）。
7. 受试者必须适合接受（经研究者评估）且即将接受标准治疗（培美曲塞+卡铂或顺铂持续4~6个周期以及随后培美曲塞维持治疗）。
8. 受试者必须为未经治疗的晚期NSCLC患者，且不适合接受根治性手术或放疗。对于既往接受过辅助和新辅助疗法（化疗、放疗、免疫疗法、生物疗法、试验性药品）或根治性放疗/化放疗联合或不联合包括免疫治疗、生物疗法、试验性药品在内的治疗方案的患者，如在复发性疾病出现前至少6个月已完成前述治疗，则允许入组。
9. 存在稳定CNS转移瘤的受试者可入组研究。
10. 筛选时ECOG/WHO PS评分为0分至1分，且过去2周内无临床显著恶化。
11. 于研究第1天时受试者的预期寿命>12周。
12. 基线时具有至少一处可通过CT或MRI精确测量（最长直径≥10 mm；淋巴结除外，其短轴必须≥15 mm）、且适用于精确重复测量的、先前未接受放疗的病灶。如果仅存在1处可测量病灶，只要该病灶既往未放疗过且在基线肿瘤评估扫描前14天内未进行活检，则该病灶可以使用（作为靶病灶）。
13. 女性患者必须采取高效的避孕措施，不得进行母乳喂养，并且必须在研究干预治疗首次给药前进行妊娠试验并呈阴性，或必须在筛选时满足下述标准之一，以证明其无生育能力：
（1）绝经后（定义为年龄>50岁并且在停止所有外源性激素治疗后闭经至少12个月）；
（2）停止外源性激素治疗后闭经≥12个月并且促黄体激素（LH）和促卵泡激素（FSH）水平下降至研究机构规定的绝经后范围的50岁以下女性也将视为绝经后女性；
（3）有接受子宫切除术、双侧卵巢切除术或双侧输卵管切除术（除输卵管结扎术外）等不可逆性绝育手术的文件记录。
14. 男性受试者必须使用屏障避孕法。

Inclusion criteria

1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
2. Provision of signed and dated, written informed consent form prior to any mandatory studyspecific procedures, sampling, and analyses.
3. Male or female, >= 18 years old.
4. Pathologically confirmed nonsquamous NSCLC.
5. Newly diagnosed with locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC (clinical stage IVA or IVB), or recurrent NSCLC (according to the International Association for the Study of Lung Cancer [IASLC] Thoracic Tumor Staging Manual [8th Edition])]), and are not suitable for radical surgery or radiotherapy.
6. According to the ARMS or Super-ARMS or NGS test results of tumor tissue or plasma from a certified laboratory approved by Chinese regulatory authorities, the tumor carries at least one of the 4 rare EGFR mutations (G719X/L861Q/S768I/T790M) (single mutation or compound mutation), but not other EGFR mutations (including ex19del/L858R).
7. Subjects must be eligible (as assessed by the investigator) and will be receiving standard treatment (pemetrexed + carboplatin or cisplatin for 4-6 cycles followed by pemetrexed maintenance therapy).
8. The subjects must be untreated advanced NSCLC patients who are not suitable for radical surgery or radiotherapy. For previously received adjuvant and neoadjuvant therapy (chemotherapy, radiotherapy, immunotherapy, biological therapy, experimental drugs) or radical radiotherapy/chemoradiotherapy with or without combination therapy including immunotherapy, biological therapy, experimental drugs. Patients who had completed the aforementioned treatment at least 6 months before the onset of recurrent disease were allowed to enroll.
9. Subjects with stable CNS metastases can be enrolled in the study.
10. ECOG/WHO PS score of 0 to 1 at screening and no clinically significant worsening within the past 2 weeks.
11. Subject's life expectancy > 12 weeks on study day 1.
12. At least one lesion at baseline that can be accurately measured by CT or MRI (longest diameter >= 10 mm; except for lymph nodes, whose short axis must be >= 15 mm) and suitable for accurate repeat measurement, has not previously received radiotherapy. If only 1 measurable lesion was present, it could be used (as a target lesion) as long as the lesion had not been previously irradiated and had not been biopsied within 14 days prior to the baseline tumor assessment scan.
13. Female patients must be on highly effective contraceptive measures, must not be breastfeeding, and must have a negative pregnancy test prior to the first dose of the study intervention, or must meet one of the following criteria at screening to demonstrate their infertility ability:
(1) Postmenopausal (defined as age > 50 years and amenorrhea for at least 12 months after discontinuation of all exogenous hormone therapy);
(2) Women under the age of 50 who have amenorrhea for >= 12 months after stopping exogenous hormone therapy and whose luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels have dropped to the postmenopausal range specified by the research institution will also be considered postmenopausal women ;
(3) Documented records of irreversible sterilization procedures such as hysterectomy, bilateral oophorectomy or bilateral salpingectomy (except tubal ligation).
14. Male subjects must use barrier contraception.

排除标准：

1. 脊髓压迫、症状性且不稳定的脑转移，除外已完成根治性治疗、未使用类固醇以及完成根治性治疗和类固醇治疗后至少2周神经状态稳定的受试者。无症状的脑转移受试者可入组研究，前提是研究者认为无需对其立即进行根治性治疗。
2. 既往ILD史、药物性ILD史、有需要类固醇治疗的放射性肺炎史，或有临床活动性ILD的证据。
3. 有任何有关重度和未得到控制的全身疾病的证据，包括未得到控制的高血压和活动性出血倾向（研究者认为这些受试者不得参与试验或这些疾病可能会影响方案依从性），或活动性感染，包括任何因感染而接受治疗的患者，不限于乙肝、丙肝以及人免疫缺陷病毒（HIV）。无需进行慢性疾病筛查。
4. 符合以下任一心脏标准：
（1）根据临床筛选心电图机获得的QTcF值和3次心电图检查（ECG）结果，平均静息校正QT间期（QTc）>470毫秒；
（2）任何具有临床意义的静息ECG节律、传导或形态异常，例如，完全左束支传导阻滞、三度心脏传导阻滞和二度心脏传导阻滞；
（3）存在任何增加QTc延长或心律失常事件风险的因素，例如电解质异常（包括：血清/血浆钾、镁和钙<正常值下限[LLN]）、心脏衰竭、先天性长QT综合征、长QT综合征家族史或40岁以下一级亲属原因不明猝死，或已知可延长QT间期和导致尖端扭转型室性心动过速的任何合并用药。
5. 以下任意实验室值显示造血功能或器官功能不足（不允许使用粒细胞集落刺激因子治疗、血小板输注和输血以满足这些标准）：
（1）中性粒细胞绝对计数低于LLN；
（2）血小板计数低于LLN；
（3）血红蛋白<90 g/L；
（4）无明显肝转移时丙氨酸氨基转移酶（ALT）>2.5 x ULN或存在肝转移时>5 x ULN；
（5）在未提示肝转移时AST>2.5 x ULN，或存在肝转移时>5 x ULN；
（6）无肝转移时总胆红素>1.5 x ULN，或有Gilbert综合征（高非结合胆红素血症）或存在肝转移时>3 x ULN；
（7）采用Cockcroft和Gault公式计算肌酐清除率<60 mL/min。
6. 研究干预治疗（奥希替尼）首次给药前2年内出现需要治疗的任何合并和/或其他活动性恶性肿瘤。
7. 除脱发和既往含铂治疗相关的2级神经病变外，在开始研究干预治疗时有任何既往治疗（如辅助化疗）导致的未消退的CTCAE 1级以上毒性。
8. 难治性恶心和呕吐、慢性胃肠道疾病、无法吞咽制剂产品、或既往接受过将妨碍吸收足量奥希替尼的大规模肠切除手术。
9. 既往使用任何全身抗癌疗法治疗不适合手术治疗或放疗的晚期NSCLC，包括化疗、生物疗法、免疫治疗或任何试验性药品。既往接受过辅助和新辅助疗法（化疗、放疗、生物疗法、试验性药品）或根治性放疗/化放疗联合或不联合包括生物疗法、试验性药品在内的治疗方案的患者，在复发性疾病出现前至少6个月已完成前述治疗，则允许入组。
10. 既往使用EGFR-TKI治疗或肿瘤免疫（IO）治疗。
11. 在首次给予研究干预治疗前4周内进行过重大手术。允许进行诸如血管通路置入、纵隔镜活检或电视胸腔镜手术（VATS）活检的外科操作。
12. 对超过30%的骨髓进行放射治疗，或首次给予研究干预治疗前4周内广泛区域照射。
13. 受试者目前正在接受（或无法在接受首次研究干预治疗之前停用）已知是细胞色素P450（CYP）3A4强诱导剂的药物或草药补充剂（至少3周前）。所有患者必须设法避免同时使用任何药物、草药补充剂和/或摄入已知对CYP3A4具有诱导作用的食物。
14. 研究第1天前4周内曾参加另一项使用试验性药品的临床研究。受试者如果处于另一项干预性研究的随访期则可以入组。
15. 参与研究计划和/或执行的人员（适用于阿斯利康公司员工和研究中心工作人员）。
16. 如果受试者不太可能遵从研究程序、限制和要求，研究者可判断受试者不得参与研究。
17. 先前入组本研究。
18. 目前妊娠（通过妊娠试验阳性确认）或哺乳。
19. 对研究干预治疗的活性或非活性辅料，或对与研究干预治疗化学结构或类别相似的药物存在超敏反应史。
20. 此外，以下情况被视为排除标准：
（1）曾行同种异体骨髓移植；
（2）采集遗传学样本的120天内曾输注含白细胞的全血。

Exclusion criteria：

1. Spinal cord compression, symptomatic and unstable brain metastases, excluding subjects who have completed curative treatment, steroid-negative, and neurologically stable subjects for at least 2 weeks after completing curative treatment and steroid treatment. Subjects with asymptomatic brain metastases may be enrolled in the study, provided the investigators believe that immediate curative treatment is not required.
2. History of previous ILD, drug-induced ILD, radiation pneumonitis requiring steroid therapy, or evidence of clinically active ILD.
3. There is any evidence of severe and uncontrolled systemic disease, including uncontrolled hypertension and active bleeding tendency (the investigator believes that these subjects should not participate in the trial or that these diseases may affect protocol compliance), or active infection, including any patient being treated for an infection, not limited to hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Chronic disease screening is not required.
4. Meet any of the following cardiac criteria:
(1) According to the QTcF value obtained by the clinical screening ECG machine and the results of 3 electrocardiogram (ECG) examinations, the average resting corrected QT interval (QTc) is > 470 ms;
(2) Any clinically significant resting ECG rhythm, conduction, or morphological abnormalities, such as complete left bundle branch block, third-degree heart block, and second-degree heart block;
(3) The presence of any factors that increase the risk of QTc prolongation or arrhythmic events, such as electrolyte abnormalities (including: serum/plasma potassium, magnesium and calcium < lower limit of normal [LLN]), heart failure, congenital long QT syndrome, long family history of QT syndrome or sudden unexplained death of a first-degree relative under 40 years old, or any concomitant medication known to prolong the QT interval and cause torsades de pointes.
5. Hematopoietic or organ insufficiency is indicated by any of the following laboratory values (granulocyte colony-stimulating factor therapy, platelet transfusions, and blood transfusions are not permitted to meet these criteria):
(1) The absolute neutrophil count is lower than the LLN;
(2) The platelet count is lower than the LLN;
(3) Hemoglobin < 90 g/L;
(4) Alanine aminotransferase (ALT) > 2.5 x ULN in the absence of obvious liver metastases or > 5 x ULN in the presence of liver metastases;
(5) AST > 2.5 x ULN in the absence of liver metastasis, or > 5 x ULN in the presence of liver metastasis;
(6) Total bilirubin > 1.5 x ULN in the absence of liver metastases, or > 3 x ULN in the presence of Gilbert syndrome (high unconjugated bilirubinemia) or in the presence of liver metastases;
(7) Calculate the creatinine clearance rate < 60 mL/min using the Cockcroft and Gault formula.
6. Any combined and/or other active malignancies requiring treatment within 2 years prior to the first dose of study intervention therapy (osimertinib).
7. With the exception of alopecia and grade 2 neuropathy associated with previous platinum-containing therapy, any unresolved CTCAE grade 1 or higher toxicity at the time of initiation of study intervention therapy (such as adjuvant chemotherapy).
8. Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous major bowel resection that would prevent adequate absorption of osimertinib.
9. Previous use of any systemic anticancer therapy for advanced NSCLC unsuitable for surgery or radiotherapy, including chemotherapy, biological therapy, immunotherapy, or any experimental drug. Patients who have previously received adjuvant and neoadjuvant therapy (chemotherapy, radiotherapy, biological therapy, experimental drugs) or radical radiotherapy/chemoradiation with or without treatment regimens including biological therapy, experimental drugs, in patients with recurrent disease enrollment was allowed if the aforementioned treatments had been completed at least 6 months prior to presentation.
10. Previous use of EGFR-TKI therapy or immuno-oncology (IO) therapy.
11. Major surgery within 4 weeks prior to the first administration of the study intervention. Surgical procedures such as vascular access placement, mediastinoscopy, or video-assisted thoracoscopic surgery (VATS) biopsy are permitted.
12. Radiation therapy to more than 30% of the bone marrow, or extensive area radiation within 4 weeks prior to the first study intervention.
13. Subject is currently receiving (or unable to discontinue prior to receiving the first study intervention) a drug or herbal supplement known to be a strong inducer of cytochrome P450 (CYP) 3A4 (at least 3 weeks ago). All patients must seek to avoid concomitant use of any medications, herbal supplements, and/or ingestion of foods known to induce CYP3A4.
14. Participated in another clinical study using an investigational drug within 4 weeks prior to study day 1. Subjects may be enrolled if they are in the follow-up period of another interventional study.
15. Persons involved in research planning and/or execution (applies to AstraZeneca employees and research center staff).
16. The investigator may judge that the subject should not participate in the study if it is unlikely that the subject will comply with the study procedures, restrictions and requirements.
17. Prior enrollment in this study.
18. Currently pregnant (confirmed by a positive pregnancy test) or breastfeeding.
19. History of hypersensitivity reactions to active or inactive excipients of the study intervention, or to drugs similar in chemical structure or class to the study intervention.
20. In addition, the following are considered exclusion criteria:
(1) Allogeneic bone marrow transplantation;
(2) Whole blood containing leukocytes has been transfused within 120 days of the collection of genetic samples.

研究实施时间：

Study execute time：

从 From 2021-08-31 00:00:00至 To 2025-08-31 00:00:00

征募观察对象时间：

Recruiting time：

从From 2021-12-10 00:00:00 至 To 2022-12-31 00:00:00

干预措施：

Interventions：

组别：	干预组	样本量：	35
Group：	Intervention group	Sample size：	35
干预措施：	奥希替尼联合铂类+培美曲塞化疗	干预措施代码：
Intervention：	Osimertinib with Platinum plus Pemetrexed Chemotherapy	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)：	四川大学华西医院	单位级别：	三级甲等
Institution hospital：	West China Hospital of Sichuan University	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：	ORR(Objective Response Rate)	Type：	Primary 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	指标类型：	次要指标
Outcome：	Safety	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	耐受性	指标类型：	次要指标
Outcome：	Tolerance	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：

标本中文名：	肿瘤组织	组织：
Sample Name：	Tumor tissue	Tissue：
人体标本去向	其它	说明	在迈杰转化医学研究（苏州）有限公司保存至项目结束后1年之后销毁
Fate of sample：	0thers	Note：	Stored in Medtech Translational Medicine Research (Suzhou) Co., Ltd. until 1 year after the end of the project

标本中文名：	尿液	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：

标本中文名：	血液	组织：
Sample Name：	Blood	Tissue：
人体标本去向	其它	说明	在北京吉因加医学检验实验室有限公司保存至项目结束后1年之后销毁
Fate of sample：	0thers	Note：	Stored in Beijing Jiyinga Medical Laboratory Co., Ltd. until 1 year after the end of the project and destroyed

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）：

N/A

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:

公开/Public

盲法：	未说明
Blinding：	Not stated
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	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）：	不适用（请阅读网址首页注册指南共享原始数据的方式内容）
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Not stated
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：	EDC
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	iMedidata
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2021-12-10 06:06:36