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注册号： Registration number：	ChiCTR2000033092
最近更新日期： Date of Last Refreshed on：	2020-05-21 14:38:15
注册时间： Date of Registration：	2020-05-20 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	减量化疗序贯PD-1抗体用于可切除 IIA-IIIA 期非小细胞肺癌新辅助治疗的临床研究
Public title：	A clinical study on the new adjuvant treatment of resectable stage IIA-IIIA non-small cell lung cancer with sequential treatment of reduced chemotherapy and PD-1 antibody
注册题目简写：
English Acronym：
研究课题的正式科学名称：	减量化疗序贯PD-1抗体用于可切除 IIA-IIIA 期非小细胞肺癌新辅助治疗的临床研究
Scientific title：	A clinical study on the new adjuvant treatment of resectable stage iia-iiia non-small cell lung cancer with sequential treatment of reduced chemotherapy and PD-1 antibody
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：	杨波	研究负责人：	杨波
Applicant：	Yang Bo	Study leader：	Yang Bo
申请注册联系人电话： Applicant telephone：	+86 13717526658	研究负责人电话： Study leader's telephone：	+86 13717526658
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：	shybomb@126.com	研究负责人电子邮件： Study leader's E-mail：	shybomb@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：	北京市海淀区复兴路28号	研究负责人通讯地址：	北京市海淀区复兴路28号
Applicant address：	28 Fuxing Road, Haidian District, Beijing, China	Study leader's address：	28 Fuxing Road, Haidian District, Beijing, 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：	中国人民解放军总医院第一医学中心
Applicant's institution：	The First Medical Center of PLA General Hospital
研究负责人所在单位：	中国人民解放军总医院第一医学中心
Affiliation of the Leader：	The First Medical Center of PLA General Hospital

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：	S2020-144-01	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：	中国人民解放军总医院第一医学中心伦理委员会
Name of the ethic committee：	Ethics Committee of the First Medical Center of PLA General Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2020-04-29 00:00:00
伦理委员会联系人：	曹江
Contact Name of the ethic committee：	Cao Jiang
伦理委员会联系地址：	北京市海淀区复兴路28号
Contact Address of the ethic committee：	28 Fuxing Road, Haidian District, Beijing, China
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：

中国人民解放军总医院第一医学中心伦理委员会

Primary sponsor：

Ethics Committee of the First Medical Center of PLA General Hospital

研究实施负责（组长）单位地址：

北京市海淀区复兴路28号

Primary sponsor's address：

28 Fuxing Road, Haidian District, Beijing, 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)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	解放军总医院第一医学中心	具体地址：	海淀区复兴路28号
Institution hospital：	The First Medical Center of PLA General Hospital l	Address：	28 Fuxing Road, Haidian District

经费或物资来源：

无

Source(s) of funding：

there is no funding

Target disease：

Locally advanced resectable non-small cell lung cancer

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

探索性研究/预试验

Study phase：

0

研究设计：

单臂

Study design：

Single arm

研究目的：

评价减量化疗序贯PD-1抗体用于IIA-IIIA期非小细胞肺癌新辅助治疗的安全性和有效性。

Objectives of Study：

To evaluate the safety and efficacy of reduced dose chemotherapy in stage IIA-IIIA non-small cell lung cancer with sequential treatment of reduced chemotherapy and PD-1 antibody.

药物成份或治疗方案详述：

试验组： 1化疗方案： 1）肺鳞癌：白蛋白紫杉醇 180-220mg/m2 VD D1+顺铂 60mg/m2 VD D1， Q3W 2）肺腺癌培美曲塞二钠 500mg/m2 VD D1+顺铂 60mg/m2 VD D1，Q3W 2 免疫治疗 PD-1抗体 200 mg VD D5 Q3W 3 治疗周期 3周（21 天）为一治疗周期，共2周期，2周期新辅助治疗后影像学评估后。 4 手术 2周期评估后行手术治疗 5 术后辅助治疗有效患者术后可行原方案化疗联合免疫治疗2周期或单纯化疗2周期。

Description for medicine or protocol of treatment in detail：

Treatment group: 1. Chemotherapy regimen: (1) Lung squamous cell carcinoma: Albumin paclitaxel 180-220mg/m2 VD D1+ cisplatin 60mg/m2 VD D1, Q3W (2) Lung adenocarcinoma Pemetrexed disodium 500mg/m2 VD D1+ cisplatin 60mg/m2 VD D1, Q3W 2. Immunotherapy PD-1 antibody 200 mg VD D5 Q3W 3. Treatment cycle 3 weeks (21 days) is a treatment cycle, with 2 cycles in total. 2 cycles of neoadjuvant therapy are evaluated after imaging. 4. Surgical treatment is performed after 2-cycle evaluation. 5. Postoperative adjuvant therapy Two cycles of chemotherapy combined with immunotherapy or two cycles of chemotherapy alone are feasible for effective patients after surgery.

纳入标准：

合格入选本研究的患者必须符合以下所有标准：
1. 在实施任何试验相关流程之前，签署书面知情同意；
2. 男或女性≥18 周岁，且≤75 周岁；
3. 细胞学或组织学诊断为非小细胞肺癌；
4. 根据实体肿瘤疗效评价标准（RECIST 1.1版），至少有一处影像学可测量病灶；
5. 未经任何治疗的、由研究者评估可手术切除的IIA-IIIA期的非小细胞肺癌患者；
6. 同意接受根治性手术治疗的患者；
7. 胸外科医师判断无手术禁忌的患者；
8. ECOG评分0-1分；
9. 预期生存时间>6个月；
10.足够器官功能，受试者需满足如下实验室指标：
1) 近14天未使用粒细胞集落刺激因子的情况下，中性粒细胞绝对值（ANC）≥1.5x109/L。
2) 近14天未输血的情况下，血小板≥100×10^9/L。
3) 近14天内无输血或使用促红细胞生成素的情况下，血红蛋白>9g/dL；
4) 总胆红素≤1.5×正常值上限（ULN）；或总胆红素>ULN但直接胆红素≤ ULN
5) 天门冬氨酸转氨酶（AST）、丙氨酸转氨酶（ALT）在≤2.5×ULN（有肝转移的患者允许ALT 或AST ≤5×ULN）；
6) 血肌酐≤1.5×ULN并且肌酐清除率（采用Cockcroft-Gault 公式计算）≥60 ml/min；
7) 凝血功能良好，定义为国际标准化比值（INR）或凝血酶原时间（PT）≤1.5倍ULN；
8) 甲状腺功能正常，定义为促甲状腺激素（TSH）在正常范围内。如基线TSH超出正常范围，如果总T3（或FT3）及FT4在正常范围内的受试者亦可入组；
9) 心肌酶谱在正常范围内（如研究者综合判断为不具有临床意义的单纯实验室异常也允许入组）；
11. 对于育龄期女性受试者，应在接受首次研究药物给药（第1周期第1天）之前的3天内接受尿液或血清妊娠试验且结果为阴性。如果尿液妊娠试验结果无法确认为阴性，则要求进行血液妊娠试验。非育龄期女性定义为绝经后至少１年，或进行过手术绝育或子宫切除术；
12. 如存在受孕风险，所有受试者（不论男性或女性）均需在整个治疗期间直至治疗末次研究药物给药后120天（或末次化疗药物给药后180天）内采用年失败率低于1%的避孕措施。

Inclusion criteria

Eligible patients for this study must meet all of the following criteria:
1. Sign the written informed consent before implementing any test related process;
2. Male or female >= 18 years old and <= 75 years old;
3. Patients diagnosed as NSCLC by cytology or histology;
4. According to the evaluation standard of solid tumor efficacy (RECIST version 1.1), patients with at least one imaging measurable focus;
5. Patients with stage iia-iiia non-small cell lung cancer that could be resected surgically evaluated by the researchers without any treatment;
6. Patients who agree to receive radical surgery;
7. The thoracic surgeon judges the patients without contraindications;
8. ECoG score 0-1;
9. Patients with expected survival time > 6 months;
10. Sufficient organ function, subjects need to meet the following laboratory indicators:
(1) In the past 14 days, when granulocyte colony stimulating factor was not used, the absolute value of neutrophil (ANC) was >= 1.5x10^9/l.
(2) Platelets >= 100 x 10^9 / l without blood transfusion in the past 14 days.
(3) Hemoglobin > 9g / dl without blood transfusion or erythropoietin in the past 14 days;
(4) Total bilirubin <= 1.5 x upper limit of normal value (ULN); or total bilirubin > ULN but direct bilirubin <= ULN
(5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were <= 2.5 x ULN (ALT or AST <= 5 x ULN were allowed in patients with liver metastasis);
(6) Serum creatinine <= 1.5 x ULN and creatinine clearance (calculated by Cockcroft Gault formula) >= 60 ml / min;
(7) The coagulation function was good, defined as INR or PT <= 1.5 times ULN;
(8) Normal thyroid function, defined as TSH in the normal range. If the baseline TSH is out of the normal range, subjects with total T3 (or FT3) and FT4 in the normal range can also be enrolled;
(9) The myocardial zymogram was in the normal range (for example, the simple laboratory abnormality without clinical significance judged by the researchers was also allowed to enter the group);
11. For female subjects of childbearing age, urine or serum pregnancy test shall be conducted within 3 days before the first study drug administration (day 1 of the first cycle) and the result shall be negative. If the result of urine pregnancy test cannot be confirmed as negative, blood pregnancy test is required. Women of non childbearing age are defined as postmenopausal women at least 1 year, who have undergone surgical sterilization or hysterectomy;
12. If there is a risk of pregnancy, all subjects (male or female) should adopt contraceptive measures with an annual failure rate of less than 1% during the whole treatment period and up to 120 days (or 180 days) after the last study drug administration.

排除标准：

符合以下标准的受试者不能入选本研究：
1. 首次给药前5年内诊断为非小细胞肺癌之外的其他恶性疾病（不包括经过根治的皮肤基底细胞癌、皮肤鳞状上皮癌、和/或经过根治性切除的原位癌）；
2. 当前正在参与干预性临床研究治疗，或在首次给药前4周内接受过其他研究药物或使用过研究器械治疗；
3. 既往接受过下列疗法：抗PD-1、抗PD-L1或抗PD-L2药物或者针对另一种刺激或协同抑制T细胞受体（例如，CTLA-4、OX-40、CD137）的药物；
4. 首次给药前2周内接受过具有抗肿瘤适应症的中成药或免疫调节作用的药物（包括胸腺肽、干扰素、白介素，除外为控制胸水局部使用）系统性全身治疗；
5. 首次给药前2年内发生过需要全身性治疗（例如使用缓解疾病药物、糖皮质激素或免疫抑制剂）的活动性自身性免疫疾病。替代疗法（例如甲状腺素、胰岛素或者用于肾上腺或垂体机能不全的生理性糖皮质激素等）不视为全身性治疗；
6. 研究首次给药前7天内正在接受全身性糖皮质激素治疗（不包括喷鼻、吸入性或其他途径的局部糖皮质激素）或任何其他形式的免疫抑制疗法；
注：允许使用生理剂量的糖皮质激素（≤10 mg/天的泼尼松或等效药物以及使用化疗前预处理剂量的糖皮质激素）；
7. 已知异体器官移植（角膜移植除外）或异体造血干细胞移植；
8. 已知对本研究药物PD-1活性成分或辅料过敏者;
9. 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）；
10. 已知人类免疫缺陷病毒（HIV）感染史（即HIV 1/2抗体阳性）；
11. 未经治疗的活动性乙肝（定义为HBsAg阳性同时检测到HBV-DNA拷贝数大于所在研究中心检验科正常值上限）；
注：符合下列标准的乙肝受试者亦可入组：
1) 首次给药前HBV病毒载量<1000拷贝/ml（200 IU/ml），受试者应在整个研究化疗药物治疗期间接受抗HBV治疗避免病毒再激活
2) 对于抗HBc（+）、HBsAg（-）、抗HBs（-）和HBV病毒载量（-）的受试者，不需要接受预防性抗HBV治疗，但是需要密切监测病毒再激活
12. 活动性的HCV感染受试者（HCV抗体阳性且HCV-RNA水平高于检测下限）；
13. 首次给药之前（第 1 周期，第 1 天）30 天内接种过活疫苗；
注：允许首次给药前 30 天内接受针对季节性流感的注射用灭活病毒疫苗；但是不允许接受鼻内用药的减毒活流感疫苗。
14. 妊娠或哺乳期妇女；
15. 存在任何严重或不能控制的全身性疾病，例如：
1) 静息心电图在节律、传导或形态上出现有重大且症状严重难以控制的异常，如完全性左束支传导阻滞，Ⅱ度以上心脏传导阻滞，室性心律失常或心房颤动；
2) 不稳定型心绞痛，充血性心力衰竭，纽约心脏病协会（NYHA）分级≥ 2 级的慢性心衰；
3) 在入选治疗前6个月内发生过任何动脉血栓、栓塞或缺血，如心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作等；
4) 血压控制不理想（收缩压＞140 mmHg，舒张压＞90 mmHg）；
5) 首次给药前1年内存在需要糖皮质激素治疗的非感染性肺炎病史，或当前存在临床活动性间质性肺病；
6) 活动性肺结核；
7) 存在需要全身性治疗的活动性或未能控制的感染；
8) 存在临床活动性憩室炎、腹腔脓肿、胃肠道梗阻；
9) 肝脏疾病如肝硬化、失代偿性肝病、急性或慢性活动性肝炎；
10) 糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L）；
11) 尿常规提示尿蛋白≥++，且证实24小时尿蛋白定量＞1.0 g者；
12) 存在精神障碍且无法配合治疗的患者；
16. 有可能干扰试验结果、妨碍受试者全程参与研究的病史或疾病证据、治疗或实验室检查值异常，或研究者认为其他不适合入组的情况研究者认为存在其他潜在风险不适合参加本研究。

Exclusion criteria：

Subjects who met the following criteria were excluded from the study:
1. Patients diagnosed as other malignant diseases other than NSCLC within 5 years before the first administration (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and / or radical resection of carcinoma in situ);
2. Patients who are currently participating in the intervention clinical research treatment, or have received other research drugs or used research instruments within 4 weeks before the first administration;
3. Patients who have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs for another stimulation or synergistic inhibition of T cell receptor (e.g., CTLA-4, OX-40, CD137);
4. Systemic systemic treatment for patients (including thymosin, interferon, interleukin, except for local use for control of pleural effusion) who have received Chinese patent medicine or immunomodulatory drugs with anti-tumor indications within 2 weeks before the first administration;
5. Active autoimmune diseases of patients requiring systemic treatment (such as the use of disease alleviation drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Substitution therapy (such as thyroxine, insulin or physiological glucocorticoid for adrenal or pituitary insufficiency) is not considered as systemic therapy;
6. Study patients who are receiving systemic glucocorticoids (excluding local glucocorticoids by nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy within 7 days before the first administration;
Note: it is allowed to use physiological dose of glucocorticoids (< 10 mg / day of prednisone or its equivalent and pre-treatment dose of glucocorticoids before chemotherapy);
7. Patients with known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
8. Patients who are known to be allergic to active ingredients or excipients of PD-1;
9. Patients who have not fully recovered from toxicity and / or complications caused by any intervention before the start of treatment (i.e., <= level 1 or baseline, excluding fatigue or alopecia);
10. Patients with known HIV infection history (i.e. HIV 1 / 2 antibody positive);
11. Untreated active hepatitis B patients (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value of laboratory in the research center);
Note: hepatitis B patients who meet the following criteria can also be included in the group:
(1) Before the first administration, the HBV viral load was less than 1000 copies / ml (200 IU / ml). The subjects should receive anti HBV treatment to avoid virus reactivation during the whole chemotherapy treatment period of the study
(2) For subjects with anti HBC +, HBsAg (-), anti HBS (-), and HBV viral load (-), prophylactic anti HBV treatment is not required, but virus reactivation needs to be closely monitored
12. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher than the detection limit);
13. Patients who received live vaccine within 30 days before the first administration (cycle 1, day 1);
Note: it is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before the first administration; however, it is not allowed to accept live attenuated influenza vaccine for intranasal administration.
14. Pregnant or lactating women;
15. Patients with any serious or uncontrollable systemic disease, such as:
(1) The resting ECG showed significant abnormalities in rhythm, conduction or morphology, such as complete left bundle branch block, heart conduction block above degree II, ventricular arrhythmia or atrial fibrillation;
(2) Unstable angina, congestive heart failure, chronic heart failure with NYHA grade >= 2;
(3) There were any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia attack, etc. in 6 months before the treatment;
(4) Blood pressure control was not ideal (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg);
(5) There was a history of noninfectious pneumonia requiring glucocorticoid treatment within one year before the first administration, or there was currently clinical active interstitial lung disease;
(6) Active tuberculosis;
(7) There are active or uncontrollable infections requiring systemic treatment;
(8) There were clinical active diverticulitis, abdominal abscess and gastrointestinal obstruction;
(9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
(10) Poor diabetes control (FBG > 10mmol / L);
(11) Routine urine test showed that urine protein was >= + +, and 24-hour urine protein was more than 1.0 G;
(12) Patients who have mental disorders and are unable to cooperate with the treatment;
16. Medical history or disease evidence that may interfere with the test results, prevent the subjects from participating in the whole process of the study, abnormal treatment or laboratory test value, or other situations that the researchers think are not suitable for the group, the researchers think there are other potential risks that are not suitable for the study.

研究实施时间：

Study execute time：

从 From 2020-06-01 00:00:00至 To 2022-06-01 00:00:00

征募观察对象时间：

Recruiting time：

从From 2020-06-01 00:00:00 至 To 2022-06-01 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	30
Group：	experimental group	Sample size：	30
干预措施：	化疗联合免疫治疗	干预措施代码：
Intervention：	chemotherapy plus immunotherapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	解放军总医院第一医学中心	单位级别：	三级甲等
Institution hospital：	The First Medical Center of PLA General Hospital l	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	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	主要病理学缓解率	指标类型：	主要指标
Outcome：	MPR	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	完全病理学缓解	指标类型：	次要指标
Outcome：	PCR	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无疾病生存期	指标类型：	次要指标
Outcome：	DFS	Type：	Secondary indicator
测量时间点：	2年DFS率	测量方法：
Measure time point of outcome：	2 year DFS rate	Measure method：

指标中文名：	手术并发症发生情况（术中、围手术期并发症）	指标类型：	次要指标
Outcome：	Occurrence of surgical complications (intraoperative and perioperative complications	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	药物严重相关不良事件	指标类型：	次要指标
Outcome：	Serious drug-related adverse events	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	新辅助治疗后病理学缓解和DFS的关系	指标类型：	附加指标
Outcome：	Relationship between pathological remission and DFS after neoadjuvant therapy	Type：	Additional indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	程序性死亡配体-1（PD-L1）的表达、突变负荷、新生抗原等免疫指标，免疫微环境及信号通路相关基因表达，免疫细胞及免疫分子多重组化检测，血液免疫细胞TCR、淋巴细胞亚群、细胞因子动态监测与疗效的相关性。	指标类型：	附加指标
Outcome：	The expression of programmed death ligand -1 (pd-l1), mutation load, newborn antigen and other immune indicators, the expression of genes related to immune microenvironment and signaling pathway, multiple histochemical detection of immune cells and immune molecules, and the correlation between TCR, lymphocyte subgroup and	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：	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：	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：	粪便	组织：
Sample Name：	Faeces	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：
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		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）：

未使用

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

Not used

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：	N/A
Blinding：	N/A
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	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）：	http://www.chictr.org.cn/index.aspx
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	http://www.chictr.org.cn/index.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：	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：	有/Yes
注册人： Name of Registration：	2020-05-20 15:09:49