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：	ChiCTR2500111060
最近更新日期： Date of Last Refreshed on：	2025-11-14 14:59:35
注册时间： Date of Registration：	2025-10-24 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	一项在局部晚期不可切除或转移性骨肉瘤患者中评估ABP1011T片的有效性和安全性的单臂、开放性Ⅱb期临床研究
Public title：	A Single-Arm, Open-Label Phase IIb Clinical Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients with Locally Advanced Unresectable or Metastatic Osteosarcoma
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项在局部晚期不可切除或转移性骨肉瘤患者中评估ABP1011T片的有效性和安全性的单臂、开放性Ⅱb期临床研究
Scientific title：	A Single-Arm, Open-Label Phase IIb Clinical Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients with Locally Advanced Unresectable or Metastatic Osteosarcoma
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：	王海平	研究负责人：	汤小东
Applicant：	Haiping Wang	Study leader：	Xiaodong Tang
申请注册联系人电话： Applicant telephone：	+86 21 5442 6122	研究负责人电话： Study leader's telephone：	+86 10 8832 6156
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：	hpwang@abpharma.com	研究负责人电子邮件： Study leader's E-mail：	Tang15877@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：	上海市闵行区光中路133弄99号	研究负责人通讯地址：	北京市西城区西直门南大街11号
Applicant address：	99 Lane133 Guangzhong RD, Shanghai, China	Study leader's address：	No.11 Xizhimen South Street, Xicheng 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：	上海爱博医药科技有限公司
Applicant's institution：	Shanghai AB PharmaTech Ltd.
研究负责人所在单位：	北京大学人民医院
Affiliation of the Leader：	Peking University People's 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：	2025PHC084-001	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：	北京大学人民医院伦理审查委员会
Name of the ethic committee：	Ethics Review Committee of Peking University People's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2025-10-10 00:00:00
伦理委员会联系人：	丛翠翠
Contact Name of the ethic committee：	Cuicui Cong
伦理委员会联系地址：	北京市西城区西直门南大街11号
Contact Address of the ethic committee：	No.11 Xizhimen South Street, Xicheng District, Beijing, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 8832 4516	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：

北京大学人民医院

Primary sponsor：

Peking University People's Hospital

研究实施负责（组长）单位地址：

北京市西城区西直门南大街11号

Primary sponsor's address：

No.11 Xizhimen South Street, Xicheng 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)：	上海市	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海爱博医药科技有限公司	具体地址：	上海市闵行区光中路133弄99号
Institution hospital：	Shanghai AB PharmaTech Ltd.	Address：	99 Lane133 Guangzhong RD, Shanghai, P.R. China

经费或物资来源：

上海爱博医药科技有限公司

Source(s) of funding：

Shanghai AB PharmaTech Ltd.

研究疾病：

晚期实体瘤（包括骨肉瘤等）

Target disease：

Advanced solid tumors (including osteosarcoma, etc.)

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：评估ABP1011T片在局部晚期不可切除或转移性骨肉瘤患者中的有效性。次要目的：评估ABP1011T片在局部晚期不可切除或转移性骨肉瘤患者中的安全性。探索性目的： 1) 评估ABP1011T片在局部晚期不可切除或转移性骨肉瘤患者中的药代动力学特征； 2) 探索性研究局部晚期不可切除或转移性骨肉瘤患者生物标志物与疗效的关系。

Objectives of Study：

Primary Objective: To evaluate the efficacy of ABP1011T tablets in patients with locally advanced unresectable or metastatic osteosarcoma. Secondary Objective: To evaluate the safety of ABP1011T tablets in patients with locally advanced unresectable or metastatic osteosarcoma. Exploratory Objectives: 1) Evaluate the pharmacokinetic characteristics of ABP1011T tablets in patients with locally advanced unresectable or metastatic osteosarcoma; 2) Explore the relationship between biomarkers and treatment efficacy in patients with locally advanced unresectable or metastatic osteosarcoma.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Voluntarily sign the informed consent form and comply with protocol requirements;
2. Age 18 years <= age <= 75 years, male or female; 
3. Expected survival >=12 weeks;
4. ECOG performance status <=1;
5. Patients with locally advanced unresectable or metastatic osteosarcoma, previously treated with systemic therapy that failed (including disease progression or intolerance), and confirmed by histopathology or cytopathology; 
6. Must have at least one measurable lesion meeting RECIST v1.1 criteria; 
7. Fully recovered from toxic effects of prior therapy (CTCAE <= Grade 1, except for specific conditions like "alopecia" or "hyperpigmentation") prior to first dose administration; additionally, the investigator must determine that the corresponding AE poses no safety risk;
8. Systolic blood pressure <= 140 mmHg, diastolic blood pressure <= 90 mmHg, with no changes in antihypertensive medications or dosages within 7 days prior to first dose administration. 
9. Organ and bone marrow function levels must meet the following requirements:  Bone marrow: Absolute neutrophil count (ANC) >= 1.5 × 10⁹/L, platelet count >= 75 × 10⁹/L, hemoglobin >= 90 g/L, with no transfusion of platelets or red blood cells within 14 days prior to the first dose, and no transfusion or treatment with biological response modifiers (e.g., granulocyte colony-stimulating factor, erythropoietin, interleukin-11) within 14 days prior to the first dose;  Liver function: No history of liver cirrhosis (decompensated cirrhosis Child-Pugh B or C). For patients without liver metastases: serum total bilirubin (TBIL) <= 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 × ULN. Patients with liver metastases must have TBIL <= 2.5×ULN, ALT and AST <= 5×ULN.  Renal function: Serum creatinine <= 1.5×ULN, or creatinine clearance > 50 mL/min (Cockcroft-Gault formula); Urine protein qualitative <= 1+; If urine protein qualitative >= 2+, 24-hour urine protein quantification is required. The investigator will determine eligibility based on test results.  Coagulation function: Prothrombin time (PT) <= 1.5 × ULN; International Normalized Ratio (INR) <= 1.5 × ULN, and activated partial thromboplastin time (APTT) <= 1.5 × ULN. 
10. Female subjects of childbearing potential must undergo a serum pregnancy test within 3 days prior to initiating study medication, with negative results, and must agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study period and for 6 months after the last study dose. Male subjects with female partners of childbearing potential must agree to use effective contraception during the study period and for 6 months after the last study dose.

排除标准：

1.既往或现患其它类型恶性肿瘤，但应除外以下情形： a) 已根治的皮肤基底细胞癌、浅表膀胱癌、皮肤鳞状细胞癌或原位宫颈癌； b) 已根治且五年内无复发的第二原发癌； 2. 对于同类药物或者研究药物任何成分过敏者或既往有严重过敏史的患者； 3. 首次研究治疗前接受过以下任一治疗或药物： a) 首次研究药物治疗前4周内进行过大手术或发生严重创伤（大手术的定义为任何进行了广泛切除的侵入性手术或者需要打开间皮细胞屏障（如胸膜腔、腹膜、脑膜）的手术。但是因诊断需要进行的组织活检是允许的。严重创伤指有未愈合的伤口、溃疡或骨折； b) 首次研究药物治疗前2周内有抗肿瘤适应症的中（成）药治疗。 c) 首次给药前4周内接受过抗肿瘤治疗（包括化疗、放疗，免疫治疗、靶向治疗、生物治疗或肿瘤栓塞术）；如为口服氟尿嘧啶类药物和内分泌治疗，停药≤2周或5个半衰期；如为亚硝基脲、丝裂霉素，停药≤6周。如果因为日程安排或药物PK特性导致洗脱时间不充分，则需要和申办者讨论; d) 首次给药前 1 周内，接受过强效CYP3A4或CYP2C9抑制剂或诱导剂； e) 首次给药前 1 周内，接受过已知可以显著延长 QT 间期的药物（如Ia类和III类抗心律失常药）； 4. 已知患有脑膜转移、脑干转移、脊髓转移和/或压迫，不稳定的中枢神经系统转移者。（但以下情况可由研究者和申办者讨论确定：若无症状，或脑转移症状稳定，并且在研究首次给药前未使用过或已停用类固醇、抗惊厥、甘露醇治疗≥4周的，研究者判定受试者获益大于风险者，可进行筛选入组）；如果无症状、或者明确接受过治疗且在研究首次给药前停用抗惊厥药和类固醇4周后临床表现稳定，则可以入组研究； 5. 具有症状的、已播散到内脏的、短期内有出现危及生命的并发症风险的晚期患者，首次给药前三周内进行过穿刺引流的有胸腔积液、腹腔积液、心包积液的患者； 6. 肿瘤病灶对主要血管包绕或浸润的影像学证据（如肺动脉、肺静脉、上腔静脉或下腔静脉等），肿瘤病灶明显入侵食管或胃肠道病灶相邻器官（大动脉或气管或胃肠道）导致具有较高的出血或瘘管风险；以及气管腔内支架植入术后的患者； 7. 筛选前的6个月内，有心血管系统疾病符合下面任一条： a) 心功能≥纽约心脏协会（NYHA）Ⅱ级的充血性心力衰竭；左心室射血分数（LVEF）＜50%； b) 需要药物治疗的严重心律失常； c) QTcF（Fridericia公式）男性＞450毫秒，女性＞470毫秒，或存在尖端扭转性室性心动过速的危险因素，如经研究者判断有临床意义的低钾血症、家族性长QT综合征病史或家族性心律失常病史（如预激综合征）；以及肌钙蛋白异常者； d) 给药前六个月内发生过心肌梗死、严重/不稳定型心绞痛、心脏血运重建、脑血管意外等； e) 过去2年内有≥3级的血栓栓塞事件病史，或因血栓高风险正在接受溶栓或抗凝治疗; 8. 筛选期电解质紊乱者； 9. 经治疗未控制稳定的系统性疾病，如糖尿病等； 10. 现患有突发性肺部疾病，间质性肺病或肺炎，肺纤维化，急性肺部疾病，需要治疗的反射性间质性肺炎等； 11. 具有明确的胃肠道出血倾向的患者，包括如下情况：有局部活动性溃疡病灶，且大便潜血（≥2+）；2个月内有黑便、呕血病史者；研究者认为可能发生消化道大出血者； 12. 既往或现患≥3级的胃肠道穿孔或内脏瘘者； 13. 有活动性感染证据： a) 乙型肝炎（HBV）（需同时满足乙型肝炎病毒表面抗原（HBsAg）阳性，且HBV-DNA值高于中心规定检测下限（如大于200IU/ml或大于1000拷贝量/ml）） b) 丙型肝炎（需同时满足丙肝抗体HCV-Ab阳性、HCV-RNA高于分析方法的检测下限）； c) 首次药前4周内有局部或全身活动性感染需要使用全身性使用抗感染治疗药物，或在筛选期间/首次给药前出现不明原因的发热>38.5°C（经研究者判断，因肿瘤原因导致的发热可以入组）； d) 通过病史或CT检查发现有活动性肺结核感染，或入组前1年内有活动性肺结核感染病史的患者，或超过1年以前有活动性肺结核感染病史但未经正规治疗； 14. 人类免疫缺陷病毒（HIV RNA）或梅毒螺旋体抗体阳性者； 15. 具有影响口服药物的多种因素（例如，无法吞咽、慢性腹泻和肠梗阻等），或存在经研究者判断严重影响胃肠道吸收的状况； 16. 既往有明确的神经或精神障碍史，包括癫痫或痴呆等； 17. 有酒精或药物依赖，或有晕针、晕血史，或不能耐受静脉穿刺采血的患者； 18. 习惯性饮用葡萄柚汁或过量茶、咖啡和/或含咖啡因的饮料，且在试验期间无法戒断者； 19. 首次给药前4周内接受过任何研究性药物，或同时参加另外一项临床研究（但除外：患者参与的是观察性、非干预性的临床研究，或正处于干预性临床研究的随访期；或上次研究用药已经超过5个半衰期）； 20. 处于妊娠期或哺乳期，或基线妊娠检测试验阳性的女性患者； 21. 研究者认为不适合纳入本研究的患者。

Exclusion criteria：

1. History of or current presence of other malignant tumors, except for the following: a) Completely resected basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ; b) Completely resected secondary primary cancer with no recurrence within five years; 2. Patients with known hypersensitivity to any component of the study drug or similar agents, or with a history of severe allergic reactions; 3. Received any of the following treatments or medications prior to the first study treatment: a) Major surgery or severe trauma within 4 weeks before the first study drug administration (Major surgery is defined as any invasive procedure involving extensive excision or breaching of the mesothelial barrier, e.g., pleural cavity, peritoneum, meninges. However, diagnostic tissue biopsies are permitted). Severe trauma refers to unhealed wounds, ulcers, or fractures; b) Received Chinese herbal medicine or traditional Chinese medicine for antitumor indications within 2 weeks prior to the first study drug dose. c) Received antitumor therapy (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biologic therapy, or tumor embolization) within 4 weeks prior to the first study drug dose; For oral fluoropyrimidine drugs and endocrine therapy, discontinuation <= 2 weeks or 5 half-lives; for nitrosoureas and mitomycin, discontinuation <= 6 weeks. If washout time is inadequate due to scheduling or drug PK characteristics, discussion with the sponsor is required; d) Within 1 week prior to first dose, received potent CYP3A4 or CYP2C9 inhibitors or inducers; e) Within 1 week prior to first dose, received drugs known to significantly prolong the QT interval (e.g., Class Ia and Class III antiarrhythmics); 4. Patients with known brain metastases, brainstem metastases, spinal cord metastases, and/or compression, or unstable central nervous system metastases. (However, the following situations may be determined through discussion between the investigator and sponsor: If asymptomatic, or if brain metastasis symptoms are stable, and if the subject has not received or has discontinued steroids, anticonvulsants, or mannitol therapy for >=4 weeks prior to the first study dose, and the investigator determines that the subject's benefit outweighs the risk, the subject may be considered for screening and enrollment); If asymptomatic, or if anticonvulsants and steroids were discontinued for 4 weeks prior to the first study dose with stable clinical presentation following confirmed treatment, enrollment may proceed. 5. Patients with symptomatic disease, visceral spread, or imminent risk of life-threatening complications in advanced disease; patients with pleural effusion, ascites, or pericardial effusion who underwent paracentesis or thoracentesis within 3 weeks prior to the first study dose. 6. Imaging evidence of tumor encasement or infiltration of major vessels (e.g., pulmonary artery, pulmonary vein, superior vena cava, inferior vena cava), significant tumor invasion into adjacent organs (aorta, trachea, or gastrointestinal tract) adjacent to esophageal or gastrointestinal lesions posing high bleeding or fistula risk; and patients who have undergone tracheal stent placement. 7. Presence of cardiovascular disease meeting any of the following criteria within 6 months prior to screening: a) Congestive heart failure with cardiac function ≥ New York Heart Association (NYHA) Class II; left ventricular ejection fraction (LVEF) < 50%; b) Severe arrhythmia requiring medication; c) QTcF (Fridericia formula) >450 ms in males or >470 ms in females, or presence of risk factors for torsades de pointes, such as clinically significant hypokalemia, familial long QT syndrome history, or familial arrhythmia history (e.g., Wolff-Parkinson-White syndrome) as determined by the investigator; and abnormal troponin levels; d) Myocardial infarction, severe/unstable angina pectoris, cardiac revascularization, cerebrovascular accident, or similar events within six months prior to dosing; e) History of >= Grade 3 thromboembolic events within the past 2 years, or currently receiving thrombolytic or anticoagulant therapy due to high thrombotic risk; 8. Patients with electrolyte disturbances during the screening period; 9. Uncontrolled systemic diseases despite treatment, such as diabetes; 10. Current acute pulmonary diseases, interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary disorders, or reflex interstitial pneumonia requiring treatment; 11. Patients with a clear tendency toward gastrointestinal bleeding, including the following conditions: presence of locally active ulcerative lesions with fecal occult blood test results ≥2+; history of melena or hematemesis within the past 2 months; patients deemed by the investigator to be at risk for major gastrointestinal hemorrhage; 12. History of or current presence of gastrointestinal perforation or visceral fistula rated >=Grade 3; 13. Evidence of active infection: a) Hepatitis B (HBV) (requires both positive hepatitis B surface antigen (HBsAg) and HBV-DNA levels above the center's specified detection limit (e.g., greater than 200 IU/mL or greater than 1000 copies/mL)) b) Hepatitis C (requires both positive HCV antibody [HCV-Ab] and HCV-RNA above the lower limit of detection for the analytical method); c) Local or systemic active infection requiring systemic antimicrobial therapy within 4 weeks prior to first dosing, or unexplained fever >38.5°C during screening/prior to first dosing (fever attributed to tumor activity may be acceptable for inclusion at investigator's discretion); d) Active pulmonary tuberculosis infection identified by medical history or CT scan, or history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or history of active pulmonary tuberculosis infection more than 1 year prior without formal treatment; 14. Positive for Human Immunodeficiency Virus (HIV RNA) or Treponema pallidum antibody; 15. Presence of multiple factors affecting oral medication administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or conditions judged by the investigator to severely impair gastrointestinal absorption; 16. History of established neurological or psychiatric disorders, including epilepsy or dementia; 17. Patients with alcohol or drug dependence, a history of needle phobia or blood phobia, or inability to tolerate venous blood collection; 18. Habitual consumption of grapefruit juice or excessive amounts of tea, coffee, and/or caffeinated beverages, with inability to abstain during the trial period; 19. Received any investigational drug within 4 weeks prior to the first dose, or concurrent participation in another clinical study (except: patients participating in observational, non-interventional clinical studies, or currently in the follow-up period of an interventional clinical study; or the last study drug administration was more than 5 half-lives ago); 20. Female patients who are pregnant or breastfeeding, or who have a positive baseline pregnancy test; 21. Patients deemed unsuitable for inclusion in this study by the investigator.

研究实施时间：

Study execute time：

从 From 2025-10-28 00:00:00至 To 2028-10-28 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-11-03 00:00:00 至 To 2028-10-18 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	65
Group：	Test group	Sample size：	65
干预措施：	ABP1011T 片	干预措施代码：
Intervention：	ABP1011T Tablet	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	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	北京大学人民医院	单位级别：	三甲
Institution hospital：	Peking University People's Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	上海市	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市第六人民医院	单位级别：	三甲
Institution hospital：	The Sixth People's Hospital of Shanghai	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	客观缓解率（ORR）	指标类型：	主要指标
Outcome：	Objective response rate (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：	无进展生存期（PFS）	指标类型：	次要指标
Outcome：	Progression-Free Survival (PFS)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	缓解持续时间（DOR）	指标类型：	次要指标
Outcome：	Duration of Relief (DOR)	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（DCR）	指标类型：	次要指标
Outcome：	Disease Control Rate (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：	4个月无进展生存率	指标类型：	次要指标
Outcome：	4-month progression-free 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：	持续反应率	指标类型：	次要指标
Outcome：	Sustained 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：	总生存期（OS）	指标类型：	次要指标
Outcome：	Overall Survival (OS)	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年内的总生存率	指标类型：	次要指标
Outcome：	Two-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：	安全性指标	指标类型：	次要指标
Outcome：	Safety indicators	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：

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）：

不适用

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:

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）：	预计2029年10月临床试验公共管理平台 ResMan IPD（http://www.medresman.org.cn）
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Expected October 2029 Clinical Trial Public Management Platform ResMan IPD (http://www.medresman.org.cn)
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和ResMan
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRFResMan
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2025-10-24 11:28:11