ChiCTR2500101013 版本V1.0 版本创建时间2025/04/18 08:31:54 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：

ChiCTR2500101013 

最近更新日期：

Date of Last Refreshed on：

2025-04-18 08:31:46 

注册时间：

Date of Registration：

2025-04-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项吡咯替尼联合色瑞替尼治疗复发性中枢神经系统孤立性纤维瘤的多中心、单臂探索性研究

Public title：

A Multicenter, Single-Arm Exploratory Study on the Combination of Pyrotinib and Ceritinib in the Treatment of Recurrent Solitary Fibrous Tumors of the Central Nervous System.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项吡咯替尼联合色瑞替尼治疗复发性中枢神经系统孤立性纤维瘤的多中心、单臂探索性研究

Scientific title：

A Multicenter, Single-Arm Exploratory Study on the Combination of Pyrotinib and Ceritinib in the Treatment of Recurrent Solitary Fibrous Tumors of the Central Nervous System.

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：

付晓君 

研究负责人：

付晓君 

Applicant：

Fuxiao Jun 

Study leader：

Fuxiao Jun 

申请注册联系人电话：

Applicant telephone：

+86 131 2032 5350

研究负责人电话：

Study leader's telephone：

+86 131 2032 5350

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：

fuxiaojun@mail.edu.ccmu.cn

研究负责人电子邮件：

Study leader's E-mail：

fuxiaojun@mail.edu.ccmu.cn

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：

北京市海淀区香山一棵松50号首都医科大学三博脑科医院

研究负责人通讯地址：

北京市海淀区香山一棵松50号首都医科大学三博脑科医院

Applicant address：

No. 50, Yikesong Road, Xiangshan, Haidian Restrict, Beijing ,China

Study leader's address：

No. 50, Yikesong Road, Xiangshan, Haidian Restrict, Beijing ,China

申请注册联系人邮政编码：

Applicant postcode：

100093

研究负责人邮政编码：

Study leader's postcode：

100093

申请人所在单位：

首都医科大学三博脑科医院

Applicant's institution：

Sanbo brain hospital capital medical university

研究负责人所在单位：

首都医科大学三博脑科医院

Affiliation of the Leader：

Sanbo brain hospital capital medical 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：

SBNK-YJ-2024-043-01

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：

首都医科大学三博脑科医院伦理委员会

Name of the ethic committee：

Ethics Committee of Sanbo Brain Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-02-05 00:00:00

伦理委员会联系人：

王鑫

Contact Name of the ethic committee：

Wang Xin

伦理委员会联系地址：

北京市海淀区香山一棵松50号首都医科大学三博脑科医院

Contact Address of the ethic committee：

No. 50, Yikesong Road, Xiangshan, Haidian Restrict, Beijing ,China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 156 0079 0102

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：

首都医科大学三博脑科医院

Primary sponsor：

Sanbo brain hospital capital medical university

研究实施负责（组长）单位地址：

北京市海淀区香山一棵松50号首都医科大学三博脑科医院

Primary sponsor's address：

No. 50, Yikesong Road, Xiangshan, Haidian Restrict, 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)：

首都医科大学三博脑科医院

具体地址：

北京市海淀区香山一棵松50号首都医科大学三博脑科医院

Institution
hospital：

Sanbo brain hospital capital medical university

Address：

No. 50, Yikesong Road, Xiangshan, Haidian Restrict, Beijing ,China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

self-raised funds

Target disease：

Solitary Fibrous Tumors of the Central Nervous System

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：

A部分：评估吡咯替尼联合色瑞替尼治疗复发性中枢神经系统SFT的安全性、有效性及最佳用药剂量； B部分：评估吡咯替尼联合色瑞替尼治疗复发性中枢神经系统SFT的一线治疗的疗效。  

Objectives of Study：

Part A: To evaluate the safety, efficacy and optimal dose of pyrotinib in combination with ceritinib in the treatment of recurrent central nervous system SFT; Part B: To evaluate the efficacy of pyrotinib in combination with ceritinib as a first-line treatment for recurrent central nervous system SFT.

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.在开展任何研究方案相关程序之前提供知情同意书； 2.年龄18-75 岁；男女均可； 3. 经病理确诊为中枢神经系统SFT，影像学明确为肿瘤复发的患者; 4.既往未接受过针对HER2或ALK的靶向治疗; 5.不需要紧急神经外科干预或脱水治疗和糖皮质激素治疗的无症状或经治的复发CNS SFT患者允许入组，包括： a. 颅脑MRI/CT对比筛查时发现的未经治疗的复发CNS SFT ；b. 既往接受过局部治疗后稳定或进展的复发CNS SFT; 6.美国东部肿瘤协作组（ECOG）体能状态评分为0~1; 7.根据RECIST 1.1，具有至少一个可测量病灶; 8.筛选时28天内LVEF>=50%; 9.筛选时预期存活时间>=12周; 10.入组前28天内器官和骨髓功能良好，定义如下。在第1周期第1天前3天内重复进行实验室检查时，也必须符合该标准。注：在评估骨髓功能当天前2周内不允许输血（红细胞或血小板）或给予G-CSF： - 中性粒细胞绝对计数（ANC）>=1.5×10^9/L（带状中性粒细胞和分叶核中性粒细胞），血小板>=100×10^9/L且Hb>=90g/L[入组前7天内无输血或无促红细胞生成素（EPO）治疗]。 - 肝脏：总胆红素<=1×正常值上限（ULN）；碱性磷酸酶、丙氨酸氨基转移酶（ALT）和天门冬氨酸氨基转移酶（AST）<=1.5 ULN；血清白蛋白>=2.5 g/dL。- 肾脏：肌酐清除率（CCr）通过Cockcroft-Gault法测定>=30 mL/min（使用实际体重）； - 国际标准化比值（INR）和凝血酶原时间（PT）<=未接受治疗性抗凝治疗的患者为1.5倍ULN; 11.筛选前有足够的治疗洗脱期，定义为：大手术>=4周；放射治疗，包括头部姑息性立体定向放疗>=4周；全脑放疗>=2周； 12.男性或女性受试者使用的避孕措施应符合当地法规对于临床研究受试者的避孕方法要求; 13.与未绝育男性伴侣存在活跃性行为的有生育能力的女性，其妊娠试验（尿液或血清）结果为阴性; 14.女性受试者必须为绝经后1年、经手术绝育或使用高效避孕措施（高效避孕措施定义为坚持并正确使用时年失败率低于1%的避孕方法）。与未绝育男性伴侣存在活跃性行为的有生育能力的女性必须同意从筛选开始使用一种高效避孕措施，并且必须同意在研究治疗末次给药后7个月内继续使用此类避孕措施。女性患者在研究期间和研究治疗末次给药后7个月内不得捐卵和哺乳。有生育能力女性的未绝育男性伴侣必须在此期间使用含杀精剂的男性避孕套（在杀精剂未获批的国家仅使用避孕套）。如果受试者的首选日常生活方式是在研究期间和药物洗脱期不进行异性性行为（禁欲），则这种做法可以接受；但是定期或偶尔禁欲、安全期避孕法和体外射精方法均不是可接受的避孕方法; 15.计划与有生育能力的女性伴侣性生活活跃的男性受试者，必须经手术绝育或从筛选开始至整个研究期间以及治疗洗脱期（研究治疗末次给药后4个月）内使用可接受的避孕措施（见表4），以防止伴侣怀孕。在此期间，男性受试者不得捐献或储存精子。如果受试者的首选日常生活方式是在研究期间和药物洗脱期不进行异性性行为（禁欲），则这种做法可以接受；但是定期或偶尔禁欲、安全期避孕法和体外射精方法均不是可接受的避孕方法。

Inclusion criteria

1. Provide informed consent prior to undertaking any study protocol-related procedures; 2. Age 18-75 years old; Male and female; 3. Patients diagnosed with central nervous system SFT by pathology and confirmed tumor recurrence by imaging; 4. Have not received targeted therapy for HER2 or ALK in the past; 5. Asymptomatic or treatment-experienced patients with relapsed CNS SFT who do not require urgent neurosurgical intervention or dehydration therapy and glucocorticoid therapy are allowed to enroll, including: a. Untreated relapsed CNS SFT found at cranial MRI/CT comparative screening; b. Relapsed CNS SFT that has stabilized or progressed after prior local therapy; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0~1; 7. Have at least one measurable lesion according to RECIST 1.1; 8. LVEF within 28 days at screening>=50%; 9. Expected survival time at screening>=12 weeks; 10. Good organ and bone marrow function within 28 days prior to enrollment, defined as follows. This criterion must also be met when the laboratory tests are repeated within 3 days before the first day of cycle 1. Note: Blood transfusions (red blood cells or platelets) or administration of G-CSF are not allowed within 2 weeks prior to the day of assessment of bone marrow function: - Absolute neutrophil count (ANC) >=1.5×10^9/L (banded neutrophils and lobulated nuclear neutrophils), platelets >=100×10^9/L and Hb >= 90 g/L [no blood transfusion or no erythropoietin (EPO) therapy within 7 days prior to enrollment]. - Liver: total bilirubin < = 1× upper limit of normal (ULN); alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=1.5 ULN; Serum albumin > = 2.5 g/dL. - Kidney: creatinine clearance (CCr) measured by Cockcroft-Gault method > = 30 mL/min (using actual body weight); - International normalized ratio (INR) and prothrombin time (PT) < = 1.5 times ULN in patients not receiving therapeutic anticoagulation; 11. Adequate therapeutic washout period prior to screening, defined as: major surgery >=4 weeks; Radiation therapy, including palliative stereotactic radiotherapy to the head > = 4 weeks; Whole brain radiotherapy >=2 weeks; 12. The contraceptive measures used by male or female subjects should comply with the contraceptive method requirements of local regulations for clinical research subjects; 13. Females of childbearing potential who are sexually active with a non-sterilized male partner with a negative pregnancy test (urine or serum); 14. Female subjects must be postmenopausal for 1 year, surgically sterile, or use highly effective contraception (highly effective contraception is defined as a contraceptive method with an annual failure rate of less than 1% when adhered to and used correctly). Females of childbearing potential who are sexually active with a non-sterilized male partner must agree to use one highly effective contraceptive method starting at screening and must agree to continue using such contraception for 7 months after the last dose of study treatment. Female patients are not allowed to donate eggs and breastfeed during the study and for 7 months after the last dose of study treatment. Non-sterilized male partners of women of childbearing potential must use a male condom containing spermicide during this period (only condoms in countries where spermicide has not been approved). This is acceptable if the subject's preferred daily lifestyle is not to engage in heterosexual sex (abstinence) during the study and during the drug washout period; However, regular or occasional abstinence, rhythm methods, and external ejaculation methods are not acceptable methods of contraception; 15. Male subjects who plan to be sexually active with a female partner of childbearing potential must be surgically sterile or use acceptable contraception (see Table 4) from screening until the entire study period and during the treatment washout period (4 months after the last dose of study treatment) to prevent the partner from becoming pregnant. Male subjects are not allowed to donate or store sperm during this time. This is acceptable if the subject's preferred daily lifestyle is not to engage in heterosexual sex (abstinence) during the study and during the drug washout period; However, regular or occasional abstinence, rhythm methods, and ejaculation methods are not acceptable methods of contraception.

排除标准：

1.不适合使用研究中的任何药物。根据当地处方信息，存在吡咯替尼、色瑞替尼的受试者不得入组本研究; 2.既往接受过本研究中的试验药品（吡咯替尼或色瑞替尼）分配，或既往接受过任何其他ERBB2、ALK的TKI、ADC类药物治疗; 3.正在接受任何合并抗肿瘤治疗; 4.同时入组另一项临床研究，除非该研究是一项观察性（非干预性）临床研究或在干预性研究的随访期; 5.难治性恶心、呕吐和腹泻、慢性胃肠道疾病或既往接受过重大肠道切除术; 6.存在药物滥用或研究者认为可能干扰受试者参加临床研究或临床研究结果评价的任何其他医学状况，如具有临床意义的心脏或心理疾病; 7.有另一种原发性恶性肿瘤病史，但以下情况除外：经根治的恶性肿瘤，在研究治疗首次给药前 5 年内无已知活动性疾病且潜在复发风险较低。例外情况包括已接受过潜在根治性治 疗的皮肤基底细胞癌和皮肤鳞状细胞癌、已充分切除的非黑色素瘤皮肤癌、已治愈的原位疾病、其他已治愈的实体瘤; 8.既往抗癌治疗的毒性尚未缓解，定义为毒性尚未缓解至≤1级或基线水平（脱发除外）。注：受试者可入组时存在研究者认为与既往抗癌治疗有关的慢性、稳定的2级毒性（定义为在首次暴露于研究干预前至少3个月内未恶化至>2级，并通过标准治疗进行管理），包括: 化疗诱导的神经病变疲乏既往免疫肿瘤治疗的残留毒性：1级或2级内分泌疾病， 可能包括： a）甲状腺功能减退症/甲状腺功能亢进症 b）1型糖尿病 c）高血糖症 d）肾上腺功能不全 e）肾上腺炎 f）皮肤色素减退（白癜风）； 9.全脑放疗或立体定向放疗结束至入组之间必须至少间隔2周。 10.患有活动性原发性免疫缺陷、已知HIV感染或活动性乙型肝炎或丙型肝炎感染，如在第1 周期第1天前28天内有病毒感染血清学证据的受试者。HCV抗体阳性的受试者只有在聚合酶链反应显示HCV RNA呈阴性的情况下可入组本研究。如果当地法规或IRB/EC要求，受试者应在入组前进行HIV检测。既往或已缓解的乙型肝炎病毒（HBV）感染受试者只有符合以下所有标准才可入组： HBsAg（-）（停止抗病毒治疗>6个月）， 抗HBC（+）（ IgG或总Ig），HBV DNA检测不到，既往影像学或活检提示无肝硬化或肝纤维化，无HCV合并感染或HCV合并感染史。 在研究期间和之后咨询当地的乙型肝炎专家。 11.需要静脉注射抗生素、抗病毒药或抗真菌药的未控制的感染； 12.在首次暴露于研究药物前6个月内有心肌梗死（MI）病史、有症状的充血性心力衰竭（纽约心脏病协会II至IV级）、筛选期肌钙蛋白水平高于ULN（由生产商规定）且无任何心肌梗死相关症状的受试者，应在入组前进行心脏科会诊，以排除MI； 13.有需要类固醇治疗的（非感染性）ILD/非感染性肺炎病史，当前患有 ILD/非感染肺炎，或筛选时影像学检查不能排除疑似ILD/非感染性肺炎； 14.在首次暴露于研究药物前30天内接种过减毒活疫苗（mRNA和复制缺陷型腺病毒疫苗不视为减毒活疫苗）。注：如果受试者入组，则在研究期间和研究干预末次给药后30天内不得接种活疫苗； 15.经研究者判断，如果受试者不太可能遵守研究程序、限制和要求，则受试者不应参与研究； 16.妊娠或哺乳期女性受试者。

Exclusion criteria：

1. Not suitable for use with any drug in the study. According to the local prescription information, subjects with pyrotinib and ceritinib are not allowed to be enrolled in this study; 2. Have previously received the investigational drug (pyrotinib or ceritinib) in this study, or have received any other TKI or ADC drug treatment for ERBB2 and ALK in the past; 3. Receiving any concomitant anti-tumor therapy; 4. Concurrent enrollment in another clinical study, unless the study is an observational (non-interventional) clinical study or during the follow-up period of the interventional study; 5. Refractory nausea, vomiting and diarrhea, chronic gastrointestinal diseases or previous major bowel resection; 6. Presence of substance abuse or any other medical condition that, in the opinion of the investigator, may interfere with the subject's participation in the clinical study or the evaluation of the results of the clinical study, such as clinically significant cardiac or psychological illness; 7. Has a history of another primary malignancy, with the following exceptions: cured malignancy with no known active disease and low potential risk of recurrence within 5 years prior to the first dose of study treatment. Exceptions include having received a potentially curative cure Treated basal cell carcinoma of the skin and squamous cell carcinoma of the skin, adequately resected non-melanoma skin cancer, cured in situ disease, other cured solid tumors; 8. Toxicity from prior anticancer therapy that has not resolved, defined as toxicity that has not resolved to Grade ≤1 or baseline level (except alopecia). Note: Subjects may be enrolled with chronic, stable Grade 2 toxicity (defined as not progressing to Grade >2 within at least 3 months prior to first exposure to study intervention and managed by standard therapy) that is considered by the investigator to be related to prior anticancer therapy, including: Chemotherapy-induced neuropathy fatigue Residual toxicity from prior immuno-oncology therapy: Grade 1 or Grade 2 endocrine disease, These may include: a) Hypothyroidism/Hyperthyroidism b) Type 1 diabetes c) Hyperglycemia d) Adrenal insufficiency e) Adrenitis f) skin hypopigmentation (vitiligo); 9. There must be at least a 2-week interval between the end of whole brain radiotherapy or stereotactic radiotherapy and enrollment. 10. Subjects with active primary immunodeficiency, known HIV infection, or active hepatitis B or hepatitis C infection, such as subjects with serological evidence of viral infection within 28 days prior to Day 1 of Cycle 1. Subjects with positive HCV antibodies can only be enrolled in this study if the polymerase chain reaction shows that HCV RNA is negative. If required by local regulations or IRB/EC, subjects should be tested for HIV prior to enrollment. Subjects with prior or remission hepatitis B virus (HBV) infection may be enrolled only if they meet all of the following criteria: HBsAg(-) (discontinuation of antiviral therapy > 6 months), anti-HBC( ( IgG or total Ig), undetectable HBV DNA, no cirrhosis or liver fibrosis on previous imaging or biopsy, no history of HCV co-infection or HCV co-infection. Consult with a local hepatitis B specialist during and after the study. 11. Uncontrolled infections requiring intravenous antibiotics, antivirals, or antifungals; 12. Subjects with a history of myocardial infarction (MI), symptomatic congestive heart failure (New York Heart Association Class II to IV), troponin levels higher than ULN (as specified by the manufacturer) during the screening period, and no myocardial infarction-related symptoms within 6 months prior to the first exposure to study drug, should have a cardiology consultation prior to enrollment to rule out MI; 13. Has a history of (non-infectious) ILD/non-infectious pneumonia requiring steroid treatment, currently has ILD/non-infectious pneumonitis, or imaging examination at screening cannot exclude suspected ILD/non-infectious pneumonitis; 14. Vaccination with a live attenuated vaccine within 30 days prior to the first exposure to the study drug (mRNA and replication-deficient adenovirus vaccines are not considered live attenuated vaccines). Note: If subjects are enrolled, they must not receive a live vaccine during the study and for 30 days after the last dose of study intervention; 15. As judged by the investigator, the subject should not participate in the study if it is unlikely to comply with the study procedures, restrictions, and requirements; 16. Pregnant or lactating female subjects.

研究实施时间：

Study execute time：

从 From 2025-05-01 00:00:00至 To 2026-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-05-01 00:00:00 至 To 2026-04-30 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

10

Group：

Experimental group

Sample size：

干预措施：

联合应用吡咯替尼+色瑞替尼

干预措施代码：

Intervention：

Combination therapy with pyrotinib and ceritinib.

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)：

首都医科大学三博脑科医院 

单位级别：

三级 

Institution
hospital：

Sanbo brain hospital capital medical university

Level of the institution：

Tertiary

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京天坛医院 

单位级别：

三甲 

Institution
hospital：

Tiantan hospital capital medical university

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

推荐剂量

指标类型：

主要指标

Outcome：

Recommended Phase 2 Dose, RP2D

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良事件发生率

指标类型：

次要指标

Outcome：

AE incidence

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中位无进展生存期

指标类型：

主要指标

Outcome：

Median progression-free survival, mPFS

Type：

Primary 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

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：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

肿瘤组织

组织：

Sample Name：

Tumor tissue

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

脑脊液

组织：

Sample Name：

Cerebrospinal fluid (CSF)

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation 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）：

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：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

无

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

None

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：

研究数据由研究人员采集，统一录入电子数据采集系统（EDC），并配有病例报告表（CRF），数据将定期审核和备份，确保数据准确性和可追溯性。

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

Data will be collected through electronic data capture (EDC) system with standardized Case Record Forms (CRFs). All data entries will be regularly reviewed and backed up to ensure accuracy and traceability.

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：

  2025-04-18 08:31:46