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：	ChiCTR2600118406
最近更新日期： Date of Last Refreshed on：	2026-02-05 09:11:02
注册时间： Date of Registration：	2026-02-05 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	维迪西妥单抗联合放疗及信迪利单抗、卡培他滨方案新辅助治疗HER2过表达局部进展期胃癌的前瞻性、II期临床研究
Public title：	Prospective Phase II Clinical Study of Neoadjuvant Therapy with Disitamab Vedotin Combined with Radiotherapy, Sintilimab, and Capecitabine for HER2-Overexpressing Locally Advanced Gastric Cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	维迪西妥单抗联合放疗及信迪利单抗、卡培他滨方案新辅助治疗HER2过表达局部进展期胃癌的前瞻性、Ⅱ期临床研究 (方案编号：RC48-GC-01）
Scientific title：	Prospective Phase II Clinical Study of Neoadjuvant Therapy with Disitamab Vedotin Combined with Radiotherapy, Sintilimab, and Capecitabine for HER2-Overexpressing Locally Advanced Gastric Cancer (Protocol Number: RC48-GC-01)
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：	潘半舟	研究负责人：	孙岩
Applicant：	Pan Banzhou	Study leader：	Sun Yan
申请注册联系人电话： Applicant telephone：	+86 182 6008 7865	研究负责人电话： Study leader's telephone：	+86 137 7060 6682
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：	panbanzhou881012@163.com	研究负责人电子邮件： Study leader's E-mail：	sunyan@188.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：	江苏省南京市玄武区百子亭42号	研究负责人通讯地址：	江苏省南京市玄武区百子亭42号
Applicant address：	No. 42, Baiziting, Xuanwu District, Nanjing City, Jiangsu Province, China	Study leader's address：	No. 42, Baiziting, Xuanwu District, Nanjing City, Jiangsu Province, China
申请注册联系人邮政编码： Applicant postcode：	210006	研究负责人邮政编码： Study leader's postcode：	210006
申请人所在单位：	江苏省肿瘤医院
Applicant's institution：	Jiangsu Cancer Hospital
研究负责人所在单位：	江苏省肿瘤医院
Affiliation of the Leader：	Jiangsu 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：	2025-018-01	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：	江苏省肿瘤医院伦理委员会
Name of the ethic committee：	Ethics Committee of Jiangsu Cancer Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2025-05-26 00:00:00
伦理委员会联系人：	刘小林
Contact Name of the ethic committee：	Liu Xiaolin
伦理委员会联系地址：	江苏省南京市百子亭42号江苏省肿瘤医院门诊六楼
Contact Address of the ethic committee：	6th Floor, Outpatient Department, Jiangsu Cancer Hospital, No. 42 Baiziting, Nanjing City, Jiangsu Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 25 8328 4707	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：

江苏省肿瘤医院

Primary sponsor：

Jiangsu Cancer Hospital

研究实施负责（组长）单位地址：

江苏省南京市玄武区百子亭42号

Primary sponsor's address：

No. 42, Baiziting, Xuanwu District, Nanjing City, Jiangsu 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)：	江苏省	市(区县)：	南京市
Country：	China	Province：	Jiangsu	City：	Nanjing
单位(医院)：	江苏省肿瘤医院	具体地址：	江苏省南京市玄武区百子亭42号
Institution hospital：	Jiangsu Cancer Hospital	Address：	No. 42, Baiziting, Xuanwu District, Nanjing City, Jiangsu Province, China

经费或物资来源：

江苏省肿瘤医院科技发展基金（RCQY202404）

Source(s) of funding：

Research Project of Jiangsu Cancer Hospital (RCQY202404)

研究疾病：

胃癌

Target disease：

Gastric 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：

单臂

Study design：

Single arm

研究目的：

主要目的：（1）评估维迪西妥单抗联合放疗及信迪利单抗、卡培他滨方案新辅助治疗HER2阳性（IHC 2+、 3+）局部进展期胃癌的病理完全缓解率和安全性（不良事件的发生率和严重程度、有临床意义的异常实验室检查结果）。次要目的：包括主要病理反应率、客观缓解率、疾病控制率、R0切除率、无进展生存期、 2年生存率。

Objectives of Study：

Primary Objectives: (1) To evaluate the pathological complete response (pCR) rate and safety (incidence and severity of adverse events, clinically significant abnormal laboratory findings) of the novel adjuvant therapy with disitamab vedotin in combination with radiotherapy, sintilimab, and capecitabine for HER2-positive (IHC 2+, 3+) locally advanced gastric cancer. Secondary Objectives: Include major pathological response rate, objective response rate , disease control rate , R0 resection rate, progression-free survival , and 2-year overall survival rate.

药物成份或治疗方案详述：

干预措施包括新辅助治疗联合放疗、手术、辅助治疗和维持治疗四个阶段。一、新辅助治疗联合放疗 1. 新辅助治疗方案：维迪西妥单抗 2.5mg/Kg, 静脉滴注, d1+信迪利单抗200mg, 静脉滴注，d1+卡培他滨 1000mg/m2, 口服，d1-14。每3周为一个治疗周期，一共3个周期。 2. 放疗：第一周期化疗开始后一周内进行，总量 DT：30Gy，2.5Gy×12f 或3Gy×10f，每天一次，每周五次。二、手术 1. 手术时间：新辅助治疗结束后 3-5 周内完成手术治疗。 2. 手术方式：近端胃切除或远端胃大部切除或全胃切除+D2淋巴结清扫术。三、术后辅助治疗术后根据临床缓解状况，在临床医生的建议下选择以下两种方案中的一种：1. 奥沙利铂130 mg/m2，静脉滴注，d1+卡培他滨1000mg/m2，口服，d1-14；2. 维迪西妥单抗 2.5mg/Kg, 静脉滴注, d1+信迪利单抗200mg, 静脉滴注，d1+卡培他滨 1000mg/m2, 口服，d1-14。两种治疗方案均是每3周为一个治疗周期，一共3个周期。四、维持治疗如术后辅助使用维迪西妥单抗+信迪利单抗+卡培他滨方案，辅助治疗结束后使用信迪利单抗200mg，静脉滴注，每3周为1个治疗周期，维持至满1年（在本研究中，考虑到患者个体差异和临床实际情况，患者可根据自身意愿和临床评估结果选择是否继续免疫维持治疗。对于选择中断治疗的患者，将详细记录中断原因，并在数据分析中采用意向性治疗方法，以减少选择性偏倚对研究结果的影响）。

Description for medicine or protocol of treatment in detail：

The intervention consists of four phases: neoadjuvant therapy combined with radiotherapy, surgery, adjuvant therapy, and maintenance therapy. I. Neoadjuvant Therapy Combined with Radiotherapy 1. Neoadjuvant regimen: Disitamab vedotin 2.5 mg/kg, IV infusion, d1 + Sintilimab 200 mg, IV infusion, d1 + Capecitabine 1000 mg/m2, orally, d1–14. Each treatment cycle lasts 3 weeks, for a total of 3 cycles. 2. Radiotherapy: Initiated within one week after starting the first chemotherapy cycle. Total dose: DT 30 Gy, delivered as 2.5 Gy × 12 fractions or 3 Gy × 10 fractions, once daily, five times per week. II. Surgery 1. Timing: Surgical resection should be performed within 3–5 weeks after completion of neoadjuvant therapy. 2. Procedure: Proximal gastrectomy, distal subtotal gastrectomy, or total gastrectomy with D2 lymphadenectomy. III. Postoperative Adjuvant Therapy After surgery, one of the following two options may be selected based on clinical response and clinician’s recommendation:1. Oxaliplatin 130 mg/m2, IV infusion, d1 + Capecitabine 1000 mg/m2, orally, d1–14; 2. Disitamab vedotin 2.5 mg/kg, IV infusion, d1 + Sintilimab 200 mg, IV infusion, d1 + Capecitabine 1000 mg/m2, orally, d1–14. Both regimens are administered in 3-week cycles for a total of 3 cycles. IV. Maintenance Therapy If the disitamab vedotin + sintilimab + capecitabine regimen was used in the adjuvant setting, maintenance therapy with sintilimab 200 mg via IV infusion every 3 weeks should be initiated after adjuvant therapy and continued for up to 1 year. (Note: In this study, considering individual patient differences and clinical practicalities, patients may choose whether to continue immunotherapy maintenance based on their and clinical evaluation. For patients who discontinue treatment, reasons for discontinuation will be thoroughly documented, and an intent-to-treat approach will be used in data analysis to minimize the impact of selection bias on study outcomes.)

纳入标准：

Inclusion criteria

1. Subjects voluntarily participate in this study, are able to sign the informed consent form, and demonstrate good compliance;
2. Aged 18-75 years (at the time of signing informed consent), both males and females are eligible;
3. Histologically and/or cytologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, diagnosed as locally advanced according to AJCC 8th edition criteria. Based on endoscopic ultrasound or contrast-enhanced CT/MRI scans (supplemented by diagnostic laparoscopy if necessary), cTNM staging must be cT1-2N1-3M0 or cT3-4aN0-3M0. Subjects must agree to undergo radical surgery, and the investigator must assess the lesion as resectable;
4. No prior systemic therapy for the current disease, including anticancer radiotherapy, chemotherapy, immunotherapy, etc.;
5. Immunohistochemistry (IHC) confirms HER2 overexpression (defined as IHC 2+ or 3+);
6. ECOG score of 0-1;
7. Expected survival period >=6 months;
8. Adequate major organ function, meeting the following criteria:
(1) Hematological tests (without transfusion or hematopoietic growth factor correction within 14 days): Hemoglobin (Hb) >=90 g/L; Absolute Neutrophil Count (ANC) >=1.5×10⁹/L; Platelets (PLT) >=80×10⁹/L;
(2) Biochemical tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <=2.5×ULN; Total Bilirubin (TBIL) <=1.5×ULN; Serum Creatinine (Cr) <=1.5×ULN or Creatinine Clearance >=60 mL/min;
(3) Coagulation function: Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) <=1.5×ULN;
(4) Doppler ultrasound assessment: Left Ventricular Ejection Fraction (LVEF) >=50%;
(5) Clinically assessed by the physician as having adequate organ function.
9. Subjects of childbearing potential must use appropriate contraception methods during the study and for 120 days after study completion, have a negative serum pregnancy test within 7 days before study enrollment, and must not be lactating.

排除标准：

1. 首次给药前 5 年内诊断为胃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. 肿瘤病灶具有出血倾向（如存在活动性溃疡肿瘤病灶且粪便潜血试验阳性、签署知情同意书前 2 个月内呕血或黑便病史、经研究者判断存在消化道大出血危险等）或研究用药前 4 周曾接受输血治疗； 3. 无法口服药物； 4. 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； 5. 既往接受过下列疗法：抗 HER2、抗 PD-1、抗 PD-L1 药物、抗 PD-L2 药物或者针对另一种刺激或协同抑制 T 细胞受体（包括但不限于 CTLA-4、 OX-40、CD137 等）的药物； 6. 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； 7. 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； 8. 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）； 9. 已知异体器官移植（角膜移植除外）或异体造血干细胞移植； 10. 已知对本研究中使用药物过敏者； 11. 周围神经病变≥2 级； 12. 已知人类免疫缺陷病毒（HIV）感染史（即 HIV 1/2 抗体阳性）； 13. 活动性乙型肝炎或丙型肝炎受试者（HBsAg 阳性同时检测到 HBV DNA 滴度高于正常值上限； HCVAb 阳性同时检测到 HCV RNA 滴度高于正常值上限）； 14. 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。 15. 妊娠或哺乳期妇女； 16. 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； 17. 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：

1. Diagnosis of malignancies other than gastric cancer within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection); 2. Tumor lesions with bleeding tendency (e.g., presence of active ulcerated tumor lesions with positive fecal occult blood test, history of hematemesis or melena within 2 months before signing informed consent, or judged by the investigator to be at risk of major gastrointestinal bleeding, etc.) or having received blood transfusion within 4 weeks prior to study treatment; 3. Inability to take oral medication; 4. Current participation in interventional clinical study treatment, or having received other investigational drugs or device therapy within 4 weeks before the first dose; 5. Prior treatment with any of the following: anti-HER2, anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); 6. Systemic treatment with Chinese proprietary medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose; 7. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment; 8. Systemic corticosteroid therapy (excluding nasal spray, inhaled, or other routes of local corticosteroids) or any other form of immunosuppressive therapy within 7 days before the first dose; Note: physiologic doses of corticosteroids (<=10 mg/day prednisone or equivalent) are permitted; 9. Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 10. Known allergy to any drug used in this study; 11. Peripheral neuropathy >= Grade 2; 12. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 13. Active hepatitis B or hepatitis C (HBsAg positive with HBV DNA titer above the upper limit of normal; HCVAb positive with HCV RNA titer above the upper limit of normal); 14. Administration of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1); Note: inactivated seasonal influenza vaccines administered by injection are allowed within 30 days prior to the first dose; however, live attenuated influenza vaccines administered intranasally are not permitted; 15. Pregnant or lactating women; 16. Presence of any severe or uncontrolled systemic disease, such as: (1) Resting ECG showing significant and symptomatic abnormalities in rhythm, conduction, or morphology that are difficult to control, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmia, or atrial fibrillation; (2) Unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) class >= 2; (3) Any arterial thrombosis, embolism, or ischemia within 6 months before enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; (4) Poorly controlled blood pressure (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); (5) History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year before the first dose, or current clinically active interstitial lung disease; (6) Active tuberculosis; (7) Active or uncontrolled infection requiring systemic treatment; (8) Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; (9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; (10) Poorly controlled diabetes (fasting blood glucose (FBG) >10 mmol/L); (11) Urinalysis showing urine protein >=++ and confirmed 24-hour urine protein >1.0 g; (12) Patients with psychiatric disorders unable to cooperate with treatment; 17. Any medical history, disease, treatment, or abnormal laboratory value that may interfere with trial results or prevent the subject from completing the study, or any other condition that the investigator deems unsuitable for enrollment or posing potential risks.

研究实施时间：

Study execute time：

从 From 2025-08-01 00:00:00至 To 2028-07-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-12-19 00:00:00 至 To 2028-07-31 00:00:00

干预措施：

Interventions：

组别：	治疗组	样本量：	35
Group：	Intervention Group	Sample size：	35
干预措施：	干预措施包括新辅助治疗联合放疗、手术、辅助治疗和维持治疗四个阶段。	干预措施代码：
Intervention：	The intervention consists of four phases: neoadjuvant therapy combined with radiotherapy, surgery, adjuvant therapy, and maintenance therapy.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	江苏省	市(区县)：	南京市
Country：	China	Province：	Jiangsu	City：	Nanjing
单位(医院)：	江苏省肿瘤医院	单位级别：	三甲
Institution hospital：	Jiangsu Cancer Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	病理完全缓解率	指标类型：	主要指标
Outcome：	pathological complete response	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	主要病理反应率	指标类型：	次要指标
Outcome：	major pathological response rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	客观缓解率	指标类型：	次要指标
Outcome：	objective response rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	疾病控制率	指标类型：	次要指标
Outcome：	disease control rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	R0切除率	指标类型：	次要指标
Outcome：	R0 resection rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无进展生存期	指标类型：	次要指标
Outcome：	progression-free survival	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	2年生存率	指标类型：	次要指标
Outcome：	2-year overall survival rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	不良事件的发生率和严重程度	指标类型：	副作用指标
Outcome：	Incidence and severity of adverse events	Type：	Adverse events
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	治疗期不良事件的发生率和严重程度	指标类型：	副作用指标
Outcome：	Incidence and severity of on-treatment adverse events	Type：	Adverse events
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	严重不良事件的发生率和严重程度	指标类型：	副作用指标
Outcome：	Incidence and severity of serious adverse events	Type：	Adverse events
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	免疫相关不良事件的发生率和严重程度	指标类型：	副作用指标
Outcome：	Incidence and severity of immune-related adverse events	Type：	Adverse events
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	因不良事件导致停止治疗的受试者数量和比例	指标类型：	副作用指标
Outcome：	Number and percentage of subjects who discontinued treatment due to adverse events	Type：	Adverse events
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	研究治疗前、治疗期间和治疗之后，生命体征、体格检查结果和实验室结果的变化	指标类型：	副作用指标
Outcome：	Changes in vital signs, physical examinations, and laboratory findings before, during, and after study treatment	Type：	Adverse events
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：	无	组织：
Sample Name：	None	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	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	80	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
Blinding：	None
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	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）：	2029年2月27日之前在临床试验公共管理平台ResMan(www.medresman.org)共享原始数据
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Share raw data on the ResMan clinical trial public management platform (www.medresman.org) by 27 February 2029.
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：	1. 病例报告表的填写与移交病例报告表由研究者填写，每个入选病例必须完成病例报告表。完成的病例报告表由临床监查员审查后，移交数据管理员，进行数据录入与管理工作。 2. 数据的录入与修改数据录入与管理由数据管理单位负责。数据管理员进行数据录入与管理。为保证数据的准确性。对病例报告表中存在的疑问，数据管理员将写入疑问解答表（DRQ），并通过临床监查员向研究者发出询问，研究者应尽快解答并返回，数据管理员根据研究者的回答进行数据修改、确认与录入，必要时可以再次发出 DRQ。 3. 数据审核和数据库锁定数据库锁定之前，项目组需要汇总试验进行中出现的所有方案偏离的事件，召开数据审核会议。数据审核会议下所作的决定都需用文件记录。所有数据均审核通过后，经研究者、研究中心、统计分析人员等确认对数据库进行锁定，锁定后数据文件不可再做改动。锁定后的数据需妥善保存备查。 4. 数据存档试验资料的保存和管理均须按 GCP 要求进行。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	1. Completion and Transfer of Case Report Forms Case Report Forms (CRFs) shall be completed by the investigator(s). A CRF must be filled out for each enrolled subject. After review by the clinical monitor, the completed CRFs shall be transferred to the data management unit for data entry and management. 2. Data Entry and Modification Data entry and management are the responsibility of the data management unit. Data managers perform data entry and management. To ensure data accuracy, any queries arising from the CRFs will be documented by the data manager in a Data Query Form (DRQ). These queries will be forwarded to the investigator via the clinical monitor. The investigator should respond as soon as possible. Based on the responses, the data manager will modify, confirm, and enter the data. If necessary, additional DRQs may be issued. 3. Data Review and Database Lock Prior to database lock, the project team must compile all protocol deviation events that occurred during the trial and convene a data review meeting. All decisions made during the data review meeting shall be documented. Once all data have been reviewed and approved, the database will be locked after confirmation by the investigator, the research center, and the statistical analysis team. After locking, no further changes may be made to the data. The locked dataset must be securely stored for future reference. 4. Data Archiving The retention and management of all trial documents shall comply with Good Clinical Practice (GCP) requirements.
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：	2026-02-05 09:10:45