ChiCTR2500107652 版本V1.0 版本创建时间2025/08/15 16:33:41 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：

 ChiCTR2500107652 

最近更新日期：

Date of Last Refreshed on：

 2025-08-15 16:33:23 

注册时间：

Date of Registration：

 2025-08-15 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

PRG2502治疗复发或难治性B淋巴细胞系肿瘤的安全性和有效性的临床研究

Public title：

A clinical study on the safety and efficacy of PRG2502 in the treatment of relapsed or refractory B-cell lineage tumors

注册题目简写：

English Acronym：

研究课题的正式科学名称：

PRG2502治疗复发或难治性B淋巴细胞系肿瘤的安全性和有效性的临床研究

Scientific title：

A clinical study on the safety and efficacy of PRG2502 in the treatment of relapsed or refractory B-cell lineage 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：

谈捷 

研究负责人：

谈捷 

Applicant：

Tan Jie 

Study leader：

Tan Jie 

申请注册联系人电话：

Applicant telephone：

 +86 18163137226

研究负责人电话：

Study leader's
telephone：

+86 18163137226

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：

 alooof@126.com

研究负责人电子邮件：

Study leader's E-mail：

 alooof@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：

湖北省荆州市沙市区江汉北路55号

研究负责人通讯地址：

湖北省荆州市沙市区江汉北路55号

Applicant address：

55 Jianghan North Road, Shashi District, Jingzhou, Hubei

Study leader's address：

55 Jianghan North Road, Shashi District, Jingzhou, Hubei

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：

荆州市第一人民医院（长江大学附属第一医院）

Applicant's institution：

The First?People’s?Hospital?of?Jingzhou（The First Affiliated Hospital of Yangtze University）

研究负责人所在单位：

荆州市第一人民医院

Affiliation of the Leader：

The First People’s Hospital of Jingzhou

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：

 KY2025-008-01

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：

荆州市第一人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Jingzhou First People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-02-20 00:00:00

伦理委员会联系人：

刘彬

Contact Name of the ethic committee：

Liu Bin

伦理委员会联系地址：

湖北省荆州市沙市区江汉北路55号

Contact Address of the ethic committee：

55 Jianghan North Road, Shashi District, Jingzhou, Hubei

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 716 8113627

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 66841709@qq.com

研究实施负责（组长）单位：

荆州市第一人民医院

Primary sponsor：

The First People’s Hospital of Jingzhou

研究实施负责（组长）单位地址：

湖北省荆州市沙市区江汉北路55号

Primary sponsor's address：

55 Jianghan North Road, Shashi District, Jingzhou, Hubei

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北省

市(区县)：

Country：

China

Province：

Hubei

City：

单位(医院)：

荆州市第一人民医院

具体地址：

湖北省荆州市沙市区江汉北路55号

Institution
hospital：

The First People’s Hospital of Jingzhou

Address：

55 Jianghan North Road, Shashi District, Jingzhou, Hubei

经费或物资来源：

深圳普瑞金生物药业股份有限公司

Source(s) of funding：

Shenzhen Pregene Biopharma Co., Ltd

研究疾病：

复发或难治性B淋巴细胞系肿瘤  

Target disease：

Relapsed or Refractory B-Cell Lineage Tumors

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：

单臂 

Study design：

Single arm 

研究目的：

评估V2502在复发或难治性B淋巴细胞系肿瘤受试者中的安全性、耐受性  

Objectives of Study：

Assess the safety and tolerability of V2502 in subjects with relapsed or refractory B-cell lineage 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：

1.筛选时符合以下诊断及治疗要求的患者： 难治/复发性B淋巴细胞系肿瘤（符合以下前5条中1条加上第6~7条）： (1)初始治疗耐药： 如CLL、部分B-NHL亚型、多发性骨髓瘤）：标准一线治疗4个疗程后，疾病未达到部分缓解（肿瘤负荷减少<50%）或出现疾病进展； (2)早期复发： 首次完全缓解后6个月内复发； (3)多次复发： 两次或以上CR后再次复发； (4)挽救治疗失败： 复发后接受至少一个周期标准挽救治疗方案仍未达到缓解； (5)干细胞移植相关： 1)自体或异基因造血干细胞移植后复发； 2)符合移植指征但因各种原因（如共病、经济等）无法进行移植患者； (6)BCMA表达检测要求： 流式细胞术（FACS）和/或免疫组织化学检测（IHC）确认的BCMA表达阳性证明；或 转录组检测（RNA-Seq）： 1)nTPM≥10，视为BCMA表达阳性； 2)nTPM值5~10，需结合其他检测方式（如蛋白表达分析或流式细胞术等）进一步确认； (7)复发患者活检要求 对于接受BCMA靶向治疗后复发的患者，需重新活检（组织或外周血样本）以确认BCMA表达。 2.年龄18~75岁，性别不限。 3.筛选时有可测量病灶： (1)B-NHL：结内病灶长径至少大于1.5 cm，结外病灶长径大于1.0 cm（参见附录1：修订的淋巴瘤疗效评价标准（2014））； (2)多发性骨髓瘤（MM），符合以下条件之一： 1)血清M蛋白水平≥0.5 g/dL（≥5 g/L）； 2)或尿M蛋白水平≥200 mg/24h； 3)或血清或尿液疾病不可测的轻链型MM：受累血清免疫球蛋白游离轻链≥10 mg/dL（100mg/L）且血清免疫球蛋白κ/γ游离轻链比值异常； (3)浆细胞白血病（PCL）：满足外周血中浆细胞绝对计数>2×10^9/L 或比例>5%； (4)其他 B 淋巴细胞系肿瘤：需符合相应疾病的可测量病灶标准（参考NCCN、IMWG、iwCLL等指南），包括但不限于外周血病理性细胞计数、骨髓浸润比例或影像学病灶（如PET-CT或CT）的大小和代谢活性等。 4.筛选时具有充足的骨髓储备，定义为符合以下所有标准： (1)中性粒细胞绝对值（ANC）> 0.6×10^9/L； (2)CD3+T细胞绝对值（ALC）≥ 0.15×10^9/L； (3)血小板（PLT）≥ 50×109/L。 5.重要脏器功能基本正常： (1)肝功能： 1)丙氨酸转氨酶（ALT）和天冬氨酸转氨酶（AST）≤3.0×正常值上限（ULN）； 2)总血清胆红素≤ 2 倍ULN（Gilbert 综合征；总血清胆红素≤ 3 倍ULN 且直接胆红素≤ 1.5 倍ULN）； (2)肾功能： 血清肌酐（Scr）≤1.5倍ULN，或者肌酐清除率≥60 mL/min（Cockcroft and Gault公式）； (3)肺功能： 1)≤1级呼吸困难且非吸氧状态的血氧饱和度>91%； 2)未发现有临床意义的胸腔积液； (4)凝血功能： 国际标准化比率（INR）且活化部分凝血酶原时间（APTT）均≤1.5倍ULN。 (5)心功能：无以下任意异常： 1)左心室射血分数（LVEF）≤45%（ECHO）； 2)纽约心脏协会（NYHA）III 或IV 级充血性心力衰竭； 3)经规范治疗仍未得到控制的持续高血压（收缩压≥140 mmHg 和/或舒张压≥90 mmHg）或肺动脉高压； 4)输注前 12 个月内有过心肌梗死或心脏手术； 5)心房或心室受累； 6)有临床意义的瓣膜病。 6.ECOG评分0~2分且预估生存期在3个月以上。 7.育龄期妇女在V2502输注前和输注前3天内的血/尿妊娠试验为阴性，任何有生育能力的男性和女性患者必须同意在整个研究过程中以及研究治疗给药后至少1年内使用有效的避孕方法。根据研究者的判断，患者有生育能力是指：他/她生物学上有能力有孩子以及有正常的性生活。没有生育能力的女性患者（即，满足至少1条以下标准）： (1)已行子宫切除术或双侧卵巢切除术，或 (2)经医学确认卵巢衰竭，或 (3)医学确认为绝经后（至少连续12个月停经）。 8.愿意并签署知情同意书。

Inclusion criteria

1. Patients meeting the following diagnostic and treatment criteria during screening: Refractory/relapsed B-cell lineage tumors (meeting one of the first five criteria below plus items 6-7): (1) Initial treatment resistance: such as CLL, certain subtypes of B-NHL, multiple myeloma; after four courses of standard first-line treatment, the disease has not achieved partial remission (tumor burden reduction <50%) or disease progression occurs; (2) Early relapse: recurrence within six months after the first complete remission; (3) Multiple relapses: recurrence again after two or more CRs; (4) Failure of salvage therapy: no response achieved after receiving at least one cycle of a standard salvage treatment regimen following recurrence; (5) Related to stem cell transplantation: 1) recurrence after autologous or allogeneic hematopoietic stem cell transplantation; 2) eligible for transplantation but unable to undergo transplantation due to various reasons (e.g., comorbidities, financial factors); (6) BCMA expression testing requirements: confirmed BCMA-positive by flow cytometry (FACS) and/or immunohistochemistry (IHC); or transcriptome sequencing (RNA-Seq): 1) nTPM>=10 is considered BCMA-positive; 2) For nTPM values between 5 and 10, further confirmation is required using other detection methods (e.g., protein expression analysis or flow cytometry); (7) Biopsy requirements for relapsed patients: For patients who relapse after receiving BCMA-targeted therapy, re-biopsy (tissue or peripheral blood sample) is required to confirm BCMA expression. 2. Age between 18 and 75, gender is not restricted. 3. Measurable lesions during screening: (1) B-NHL: the long diameter of nodal lesions should be at least greater than 1.5 cm, and extranodal lesions greater than 1.0 cm (see Appendix 1: Revised Response Criteria for Malignant Lymphoma (2014)); (2) Multiple Myeloma (MM), meeting at least one of the following conditions: 1) serum M-protein level >=0.5 g/dL (>=5 g/L); 2) or urine M-protein level >=200 mg/24h; 3) or light chain MM with non-measurable disease in serum or urine: involved serum immunoglobulin free light chain >=10 mg/dL (100 mg/L) and abnormal serum immunoglobulin κ/λ free light chain ratio; (3) Plasma Cell Leukemia (PCL): peripheral blood absolute plasma cell count >2×10^9/L or percentage >5%; (4) Other B-cell lineage malignancies: must meet measurable lesion criteria specific to the corresponding disease (refer to guidelines such as NCCN, IMWG, iwCLL), including but not limited to pathological cell counts in peripheral blood, proportion of bone marrow infiltration, or size and metabolic activity of imaging lesions (e.g., PET-CT or CT). 4. Have adequate bone marrow reserve at screening, defined as meeting all of the following criteria: (1) absolute neutrophil count (ANC) > 0.6×10^9/L; (2) absolute CD3+ T cell count (ALC) >= 0.15×10^9/L; (3) platelets (PLT) >= 50×10^9/L. 5. Major organ functions are basically normal: (1) Liver function: 1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3.0 × upper limit of normal (ULN); 2) Total serum bilirubin <=2 times ULN (Gilbert's syndrome; total serum bilirubin <=3 times ULN and direct bilirubin <=1.5 times ULN); (2) Renal function: Serum creatinine (Scr) <=1.5 times ULN, or creatinine clearance >=60 mL/min (Cockcroft and Gault formula); (3) Pulmonary function: 1) Grade <=1 dyspnea and oxygen saturation without oxygen support >91%; 2) No clinically significant pleural effusion detected; (4) Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) both <=1.5 times ULN; (5) Cardiac function: None of the following abnormalities: 1) Left ventricular ejection fraction (LVEF) <=45% (ECHO); 2) New York Heart Association (NYHA) Class III or IV congestive heart failure; 3) Persistent hypertension (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg) or pulmonary hypertension that remains uncontrolled despite standard treatment; 4) Myocardial infarction or cardiac surgery within 12 months prior to infusion; 5) Atrial or ventricular involvement; 6) Clinically significant valvular disease. 6. ECOG score 0-2 and estimated survival period of more than 3 months. 7. Female patients of childbearing age must have a negative blood/urine pregnancy test within 3 days prior to the V2502 infusion and prior to each subsequent infusion. Any male or female patient with reproductive capacity must agree to use effective contraception throughout the study period and for at least 1 year after discontinuation of study treatment. According to the investigator's judgment, a patient is considered to have reproductive capacity if he/she is biologically capable of having children and has regular sexual activity. Female patients without reproductive capacity (i.e., meeting at least one of the following criteria): (1) history of hysterectomy or bilateral oophorectomy, or (2) medically confirmed ovarian failure, or (3) medically confirmed postmenopausal status (at least 12 consecutive months of amenorrhea). 8. Willing and sign the informed consent form.

排除标准：

1.筛选前有有临床意义的中枢神经系统病者，如癫痫、脑血管缺血/出血、瘫痪、失语、中风、严重脑损伤、痴呆、帕金森病、小脑疾病、脑器质性综合征、精神疾病或任何伴累及中枢神经系统的自身免疫性疾病。
2.有其他恶性肿瘤的受试者（已治愈并在筛选前2年以上未见活动性病情的患者，及非黑色素瘤皮肤癌患者、基底细胞或鳞状上皮细胞皮肤癌患者、局部前列腺癌患者、导管原位癌、乳头状或滤泡状甲状腺癌患者及原位癌患者除外）。
3.筛选时符合以下任何一种情况者： (1)乙肝表面抗原（HBsAg）和/或乙肝 e 抗原（HBeAg）阳性； (2)乙肝e 抗体（HBe-Ab）和/或乙肝核心抗体（HBc-Ab）阳性，且 HBV-DNA 拷贝数大于可测量下限； (3)丙肝抗体（HCV-Ab）阳性； (4)抗梅毒螺旋体抗体TP-Ab和TRUST均阳性； (5)HIV 抗体检测阳性。
4.存在不可控的活动性感染。筛选时存在因瘤体阻塞或压迫导致的需要紧急处理的临床急症（如肠梗阻或血管压迫等）者。
5.筛选时存在活动性出血者。
6.筛选前6个月内有深静脉血栓或肺栓塞史者。
7.在输注前的指定时间内使用以下任何药物或治疗方法者： (1)在输注前1周内使用过淋巴细胞毒性化疗（＞3 t1/2除外）； (2)在输注前3天内使用过非淋巴细胞毒性的细胞毒性化疗药物（＞3 t1/2除外）； (3)在5个半衰期内，接受过靶向治疗、表观遗传治疗、其他临床研究药物治疗或使用侵入性研究医疗设备进行等影响药效判定的治疗（包括抗肿瘤治疗）； (4)在1周内接受过免疫/非免疫定向全身治疗； (5)在输注前4周内接受过放疗；放疗中/后疾病进展（PD）者除外； (6)输注前4周内有异基因造血干细胞移植史，且存在急性移植物抗宿主病（GvHD）或中重度慢性2至4级的GvHD，需要系统性药物治疗（如激素或其他免疫抑制剂等）的患者； (7)在给药2周内进行过手术或计划在给药后2周内进行手术，进行局部麻醉的手术除外； (8)输注前4周内接受了供者淋巴输注（DLI）； (9)在输注前4周内或计划在研究期间接种活疫苗/减毒活疫苗； (10)接受过任何水泡性口炎病毒G（VSVG）假型病毒进行的治疗。
8.已知对V2502及其制剂成份或研究中可能使用的药物（包括托珠单抗、白蛋白等）的任何成份有变态反应、超敏反应、不耐受或禁忌症者，或既往发生过严重过敏反应者。
9.有临床意义的原发性免疫缺陷。
10.经研究者评估存在以下不适合参与临床试验的情况者：不适合进行输注的临床状况（如难以建立和维持静脉通路等），或可能影响受试者安全或依从性的其他医疗状况，及任何可能干扰研究目标实现的身体或心理状况等。

Exclusion criteria：

1. Patients with clinically significant central nervous system disorders prior to screening, such as epilepsy, cerebral ischemia/hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndrome, psychiatric disorders, or any autoimmune disease involving the central nervous system.
2. Subjects with other malignancies (excluding those who have been cured and have had no active disease for more than 2 years prior to screening, as well as patients with non-melanoma skin cancer, basal cell or squamous epithelial cell skin cancer, localized prostate cancer, ductal carcinoma in situ, papillary or follicular thyroid cancer, and carcinoma in situ).
3. Subjects who meet any of the following conditions during screening: (1) positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg); (2) positive for hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab), and HBV-DNA copy number exceeds the lower limit of measurement; (3) positive for hepatitis C virus antibody (HCV-Ab); (4) positive for both anti-treponema pallidum antibody (TP-Ab) and TRUST; (5) positive for HIV antibody test.
4. Presence of uncontrolled active infection. Subjects with clinical emergencies requiring urgent intervention due to tumor obstruction or compression (e.g., intestinal obstruction or vascular compression) during screening.
5. Patients with active bleeding during screening.
6. Exclude individuals with a history of deep vein thrombosis or pulmonary embolism within the past 6 months.
7. Patients who have received any of the following medications or treatments within the specified time period before infusion: (1) Lymphocyte cytotoxic chemotherapy (except for >3 t1/2) within 1 week prior to infusion; (2) Non-lymphocyte cytotoxic chemotherapy drugs (except for >3 t1/2) within 3 days prior to infusion; (3) Targeted therapy, epigenetic therapy, other investigational drug treatments, or therapies using invasive investigational medical devices that may affect efficacy evaluation (including anti-tumor treatments) within 5 half-lives; (4) Immune/non-immune targeted systemic treatment within one week; (5) Received radiotherapy within 4 weeks prior to infusion, except for patients with disease progression (PD) during or after radiotherapy; (6) History of allogeneic hematopoietic stem cell transplantation within 4 weeks prior to infusion, with acute graft-versus-host disease (GvHD) or moderate to severe chronic grade 2–4 GvHD requiring systemic medication treatment (such as hormones or other immunosuppressants); (7) Undergone surgery within 2 weeks prior to drug administration or planned surgery within 2 weeks after drug administration, excluding surgeries performed under local anesthesia; (8) Received donor lymphocyte infusion (DLI) within 4 weeks prior to infusion; (9) Received live/attenuated live vaccines within 4 weeks prior to infusion or planning to receive such vaccines during the study period; (10) Previously received treatment with vesicular stomatitis virus G (VSVG) pseudotyped virus.
8. Any participant with a known allergy, hypersensitivity, intolerance, or contraindication to any component of V2502 and its formulation ingredients, or drugs that may be used during the study (including tocilizumab, albumin, etc.), or who has a history of severe allergic reactions.
9. Clinically significant primary immunodeficiency.
10. Individuals assessed by the investigator as having any of the following conditions that are unsuitable for participation in the clinical trial: clinical conditions unsuitable for infusion (e.g., difficulty establishing and maintaining intravenous access), or other medical conditions that may affect subject safety or compliance, as well as any physical or mental conditions that may interfere with the achievement of the study objectives.

研究实施时间：

Study execute time：

从 From 2025-05-29 00:00:00至 To 2027-05-29 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-05-29 00:00:00 至 To 2026-05-29 00:00:00

干预措施：

Interventions：

组别：

C剂量组

样本量：

 6

Group：

Dose C group

Sample size：

干预措施：

输注0.4×10^9 TU的V2502

干预措施代码：

Intervention：

Infusion of V2502 at 0.4×10^9 TU

Intervention code：

组别：

B剂量组

样本量：

 6

Group：

Dose B group

Sample size：

干预措施：

输注0.3×10^9 TU的V2502

干预措施代码：

Intervention：

Infusion of V2502 at 0.3×10^9 TU

Intervention code：

组别：

A剂量组

样本量：

 6

Group：

Dose A group

Sample size：

干预措施：

输注0.2×10^9 TU的V2502

干预措施代码：

Intervention：

Infusion of V2502 at 0.2×10^9 TU

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

  

Country：

China

Province：

Hubei

City：

单位(医院)：

 荆州市第一人民医院 

单位级别：

 三级甲等 

Institution
hospital：

The First People’s Hospital of Jingzhou

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

客观缓解率（ORR）和完全缓解率（CRR）

指标类型：

次要指标

Outcome：

objective response rate (ORR) and complete response rate (CRR)

Type：

Secondary indicator

测量时间点：

输注后D28以及第2、3、6、9、12、18、24个月

测量方法：

Measure time point of outcome：

Day 28 post-infusion and at Months 2, 3, 6, 9, 12, 18, and 24

Measure method：

指标中文名：

药效动力学（PD）评价

指标类型：

次要指标

Outcome：

Pharmacodynamic (PD) Evaluation

Type：

Secondary indicator

测量时间点：

V2502输注前（Day 0）及输注后的随访阶段

测量方法：

Measure time point of outcome：

Follow-up phase before (Day 0) and after V2502 infusion

Measure method：

指标中文名：

药代动力学（PK）评价

指标类型：

次要指标

Outcome：

Pharmacokinetic (PK) Evaluation

Type：

Secondary indicator

测量时间点：

基线、D2、D6、D10、D14、D21、D28，第2、3、6、9、12、18、24个月

测量方法：

Measure time point of outcome：

Baseline, D2, D6, D10, D14, D21, D28, Months 2, 3, 6, 9, 12, 18, 24

Measure method：

指标中文名：

安全性评价

指标类型：

主要指标

Outcome：

Safety Evaluation

Type：

Primary indicator

测量时间点：

本研究将全程监测并记录发生的所有不良事件，记录并评价各项安全性指标在V2502治疗前后的异常变化。

测量方法：

Measure time point of outcome：

This study will monitor and record all adverse events throughout the process, and document and evalu

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

全血

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：

正在进行

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:

不公开/Private

盲法：

无

Blinding：

None

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）：

试验完成后6个月内公开，合理要求下直接联系项目负责人交流原始数据。

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

The data will be publicly available within 6 months after the completion of the experiment, and the principal investigator can be contacted directly for access to the raw data under reasonable requests.

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：

本研究采用电子数据采集（electronic data capture，EDC）系统进行数据管理。

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

This study uses an electronic data capture (EDC) system for data management.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-08-15 16:33:23