ChiCTR2600123983 版本V1.0 版本创建时间2026/05/06 10:12:01 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：

 ChiCTR2600123983 

最近更新日期：

Date of Last Refreshed on：

 2026-05-06 10:11:55 

注册时间：

Date of Registration：

 2026-05-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评估钇-90树脂微球选择性内放射治疗复发性胶质母细胞瘤的安全性与技术可行性：一项前瞻性、单臂、单中心探索性临床研究

Public title：

A Prospective, Single-Arm, Single-Center Exploratory Clinical Study to Evaluate the Safety and Technical Feasibility of Selective Internal Radiotherapy with Yttrium-90 Resin Microspheres in Recurrent Glioblastoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评估钇-90树脂微球选择性内放射治疗复发性胶质母细胞瘤的安全性与技术可行性：一项前瞻性、单臂、单中心探索性临床研究

Scientific title：

A Prospective, Single-Arm, Single-Center Exploratory Clinical Study to Evaluate the Safety and Technical Feasibility of Selective Internal Radiotherapy with Yttrium-90 Resin Microspheres in Recurrent Glioblastoma

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：

苏伟 

研究负责人：

杨学军 

Applicant：

Su Wei 

Study leader：

Yang Xuejun 

申请注册联系人电话：

Applicant telephone：

 +86 135 8181 5028

研究负责人电话：

Study leader's
telephone：

+86 130 1132 9950

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：

 swa01179@btch.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 yxja03728@btch.edu.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：

中国北京市昌平区立汤路168号

研究负责人通讯地址：

中国北京市昌平区立汤路168号

Applicant address：

168 Litang Road, Changping District, Beijing, China

Study leader's address：

168 Litang Road, Changping District, Beijing, China

申请注册联系人邮政编码：

Applicant postcode：

 102218

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

北京清华长庚医院

Applicant's institution：

Beijing Tsinghua Changgung Hospital

研究负责人所在单位：

北京清华长庚医院

Affiliation of the Leader：

Beijing Tsinghua Changgung 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：

 26066-0-02

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：

北京清华长庚医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Beijing Tsinghua Changgung Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-09 00:00:00

伦理委员会联系人：

刘曼婷

Contact Name of the ethic committee：

Liu Manting

伦理委员会联系地址：

中国北京市昌平区立汤路168号

Contact Address of the ethic committee：

168 Litang Road, Changping District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 56118567

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 IRB@btch.edu.cn

研究实施负责（组长）单位：

北京清华长庚医院

Primary sponsor：

Beijing Tsinghua Changgung Hospital

研究实施负责（组长）单位地址：

中国北京市昌平区立汤路168号

Primary sponsor's address：

168 Litang Road, Changping 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)：

北京清华长庚医院

具体地址：

中国北京市昌平区立汤路168号

Institution
hospital：

Beijing Tsinghua Changgung Hospital

Address：

168 Litang Road, Changping District, Beijing, China

经费或物资来源：

武汉社泰医疗科技有限公司

Source(s) of funding：

Wuhan Shetai Medical Technology Co., Ltd.

研究疾病：

胶质母细胞瘤  

Target disease：

Glioblastoma multiforme

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：

主要目的： 评估钇-90树脂微球超选择性动脉内介入治疗复发性胶质母细胞瘤的安全性和可行性。 次要目的： 初步评估肿瘤控制情况。  

Objectives of Study：

Primary Objective: To evaluate the safety and feasibility of superselective intra-arterial selective internal radiotherapy with yttrium-90 resin microspheres in patients with recurrent glioblastoma. Secondary Objective: To preliminarily evaluate tumor control.

药物成份或治疗方案详述：

本研究采用钇[90Y]微球注射液（易甘泰?，SIR-Spheres?）进行干预。主要活性成份为氯化钇[90Y]，辅料包括氧化钇、硫酸、磷酸钠、磷酸二氢钠、树脂微球及注射用水；制剂为不透明混悬液，微球直径20–60 μm，物理半衰期64 h。治疗方式为经介入途径实施选择性内放射治疗（SIRT）：治疗前行增强MRI、DSA/CTA血管测绘及99Tcm-MAA SPECT/CT评估肺分流和非靶栓塞风险，并采用MIRD单室模型或多室模型进行个体化剂量计算；随后通过超选择性微导管将钇-90树脂微球输注至肿瘤供血动脉，目标治疗区域预计吸收剂量为93–100 Gy或以上。治疗后行SPECT/CT或PET/CT确认分布，并于术后1个月、3个月、6个月进行随访评估。术后6个月内原则上不对靶病灶追加其他抗肿瘤治疗。 

Description for medicine or protocol of treatment in detail：

This study uses yttrium [90Y] microsphere injection (Yigantai?, SIR-Spheres?) as the investigational intervention. The principal active ingredient is yttrium [90Y] chloride, and the excipients include yttrium oxide, sulfuric acid, sodium phosphate, sodium dihydrogen phosphate, resin microspheres, and water for injection. The formulation is an opaque suspension, with a microsphere diameter of 20–60 μm and a physical half-life of 64 hours. The treatment is administered as selective internal radiotherapy (SIRT) via an interventional approach. Before treatment, contrast-enhanced MRI, DSA/CTA vascular mapping, and 99mTc-MAA SPECT/CT are performed to assess the lung shunt fraction and the risk of non-target embolization, and individualized dosimetry is calculated using the MIRD single-compartment or multicompartment model. Subsequently, yttrium-90 resin microspheres are infused into the tumor-feeding artery through a superselectively positioned microcatheter, with an intended absorbed radiation dose of 93–100 Gy or higher to the target treatment area. After treatment, SPECT/CT or PET/CT is performed to confirm microsphere distribution, and follow-up evaluations are conducted at 1, 3, and 6 months postoperatively. In principle, no additional antitumor therapy directed at the target lesion is allowed within 6 months after the procedure. 

纳入标准：

1. 年龄≥18周岁，同意参与试验并签署知情同意书； 2. 预期寿命≥12周； 3. 研究参与者愿意并能够遵守试验检查、干预和随访计划； 4. 经组织病理+分子病理（IDH野生型）整合诊断确诊为脑胶质瘤，符合2021版WHO中枢神经系统肿瘤分类标准，病理分级为4级； 5. 根据神经肿瘤反应评估（Response Assessment in Neuro-Oncology, RANO）标准，经增强MRI证实存在明确肿瘤进展或复发，且存在至少1个可测量的强化病灶（双向直径≥1cm且≤5cm）； 6. 已接受手术及放化疗标准治疗，且颅脑辐射总剂量<66Gy，有或无肿瘤电场治疗； 7. 卡诺夫斯凯计分（Karnofsky Performance Status，KPS）≥60分，具体评分见表1； 8. 颅脑放疗完成后的间隔时间必须为>6个月。有组织被证实在之前的放疗区域之外有肿瘤复发或进展，需要颅脑放疗完成后的间隔时间至少12周； 9. 经多学科团队（Multidisciplinary team，MDT）评估或神经外科会诊确认：不适合再次接受完全性或次全性肿瘤切除术，且无其他根治性手术指征； 10. 从最后一次化疗或靶向治疗至推测干预日期的间隔时间≥1个周期或≥2个生物学半衰期，即 (1)距替莫唑胺末次给药≥4周； (2)距洛莫司汀或其他亚硝基脲末次给药≥6周； (3)距离小分子靶向药物（酪氨酸激酶抑制剂或类似药物）末次给药≥2周； (4)距最后一次贝伐单抗或其他基于血管内皮生长因子（VEGF）抗体的末次给药≥12周； 11. 若患者正在接受类固醇治疗，必须确保在登记参加研究前至少7天内，将类固醇剂量稳定或降低至地塞米松等效剂量≤6 mg/d； 12. 在登记参加研究前14天内，具备足够的器官及骨髓功能，需满足以下化验要求： (1)国际标准化比值（International normalized ratio，INR）≤1.2（未抗凝状态）； (2)血小板（Platelet，PLT）≥100×10^9/L； (3)血肌酐（Serum creatinine，Scr）≤1.5 mg/dL（或换算为≤132.6 μmol/L，二者可任选其一统一标注）； (4)中性粒细胞绝对计数（Absolute neutrophil count，ANC）≥1.5×10^9/L； (5)血红蛋白（Hemoglobin，Hb）≥90 g/L。 13. 有生育潜能的女性患者，在登记参加研究前14天内的妊娠试验呈阴性； 14. 研究参与者为男性或未怀孕且有生育潜能的女性，必须同意使用医学上可接受的避孕方法； 15. 血管造影评估后纳入标准： 15.1.神经血管解剖要求：需具备适合微导管置入的血管解剖结构，确保能够安全地进行微导管置入（最多两个位置），并将钇-90微球注入至研究团队确认的T1增强病灶区。 15.2.治疗区域要求：治疗区域必须位于非脑功能区，总治疗体积应不超过150cc（仅包括T1增强区域，肿瘤内部的非增强坏死区域不计入）。脑功能区定义为与语言、视觉、感觉和运动功能相关的脑区。 注： 表1. 卡诺夫斯凯计分（Karnofsky Performance Status，KPS）标准 评分 描述 100分 正常，无任何疾病相关症状或体征； 90分 能正常活动，仅有极轻微的症状或体征； 80分 勉强进行正常活动，有一些症状或体征； 70分 生活能自理，但不能维持正常生活和工作； 60分 生活能大部分自理，但偶尔需要别人帮助； 50分 常需要人照料； 40分 生活不能自理，需要特别照顾和帮助； 30分 生活严重不能自理； 20分 病重，需要住院和积极的支持治疗； 10分 重危，临近死亡； 0分 死亡。

Inclusion criteria

1. Age >=18 years, willing to participate in the trial, and able to sign the informed consent form; 2. Expected survival >=12 weeks; 3. The participant is willing and able to comply with the study examinations, intervention, and follow-up schedule; 4. Histopathologically and molecularly confirmed glioma with an integrated diagnosis of IDH-wildtype, in accordance with the 2021 WHO Classification of Tumors of the Central Nervous System, with a pathological grade of Grade 4; 5. Definite tumor progression or recurrence confirmed by contrast-enhanced MRI according to the Response Assessment in Neuro-Oncology (RANO) criteria, with at least one measurable enhancing lesion (bidimensional diameter >=1 cm and <=5 cm); 6. Prior receipt of standard treatment including surgery and chemoradiotherapy, with a total cranial radiation dose <66 Gy, with or without tumor treating fields therapy; 7. Karnofsky Performance Status (KPS) >=60, as detailed in Table 1; 8. The interval since completion of cranial radiotherapy must be >6 months. If tumor recurrence or progression outside the previously irradiated field has been histologically confirmed, the interval since completion of cranial radiotherapy must be at least 12 weeks; 9. Confirmed by multidisciplinary team (MDT) assessment or neurosurgical consultation to be unsuitable for repeat gross total or subtotal tumor resection, and with no other indication for curative surgery; 10. The interval from the last chemotherapy or targeted therapy to the planned intervention date must be >=1 treatment cycle or >=2 biological half-lives, specifically: (1) At least 4 weeks since the last dose of temozolomide; (2)At least 6 weeks since the last dose of lomustine or other nitrosoureas; (3)At least 2 weeks since the last dose of a small-molecule targeted agent (tyrosine kinase inhibitor or similar agent); (4)At least 12 weeks since the last dose of bevacizumab or any other vascular endothelial growth factor (VEGF) antibody-based therapy; 11. If the patient is receiving corticosteroids, the corticosteroid dose must have been stable or reduced to a dexamethasone-equivalent dose of ≤6 mg/day for at least 7 days before enrollment; 12. Adequate organ and bone marrow function within 14 days before enrollment, meeting the following laboratory requirements: (1) International normalized ratio (INR) <=1.2 (in the absence of anticoagulation); (2)Platelet count (PLT) >=100 × 10^9/L; (3)Serum creatinine (Scr) <=1.5 mg/dL (or <=132.6 μmol/L; either unit may be used consistently); (4)Absolute neutrophil count (ANC) >=1.5 × 10^9/L; (5) Hemoglobin (Hb) >=90 g/L. 13. For women of childbearing potential, a negative pregnancy test within 14 days before enrollment; 14. Male participants or non-pregnant women of childbearing potential must agree to use medically acceptable contraception; 15. Inclusion criteria after angiographic evaluation: 15.1. Neurovascular anatomy requirement: Suitable vascular anatomy for microcatheter placement, ensuring that microcatheterization can be performed safely (at up to two positions), and that yttrium-90 microspheres can be infused into the T1-enhancing lesion area confirmed by the study team. 15.2. Treatment territory requirement: The treatment area must be located in a non-eloquent brain region, and the total treatment volume must not exceed 150 cc (including only the T1-enhancing region; non-enhancing necrotic areas within the tumor are excluded). Eloquent brain areas are defined as regions related to language, vision, sensory, and motor functions. Note: Table 1. Karnofsky Performance Status (KPS) Scale Score Description 100 Normal, with no disease-related symptoms or signs; 90 Able to carry on normal activity, with only minor symptoms or signs; 80 Able to carry on normal activity with effort; some symptoms or signs present; 70 Able to care for self, but unable to carry on normal activity or work; 60 Able to care for most personal needs, but occasionally requires assistance; 50 Requires considerable assistance and frequent medical care; 40 Disabled; requires special care and assistance; 30 Severely disabled; 20 Very sick; hospitalization and active supportive treatment required; 10 Moribund; approaching death; 0 Dead.

排除标准：

（1） 肿瘤邻近或侵犯脑干； （2） 既往接受过2线及以上系统抗肿瘤治疗，替莫唑胺维持治疗不计入治疗线数； （3）接受过胸部放疗； 根据研究者的判断，伤口裂开的风险增加（例如，过去3个月内接受过脑部手术，皮肤状况较差，和/或既往手术区域感染，或神经外科医生认为有增加感染风险的任何其他情况）； （4）有无法控制的癫痫； （5）有严重和/或控制不充分的并发疾病；有以下情况的患者不符合纳入条件： 1）药物控制不佳的3级或更高级别高血压；2）有症状或不稳定的心脏疾病，已知有右向左分流，或重度肺动脉高压（肺动脉压>90 mmHg）；3）指尖脉搏血氧仪测定的肺功能不全（动脉氧分压（Arterial partial pressure of oxygen，PaO?）<60 mmHg，或动脉血氧饱和度（Arterial Oxygen Saturation，SaO?）<90%）；4）需要全身性治疗的持续或活动性细菌或病毒感染（包括艾滋病毒）；5）肺炎；6）限制对研究要求依从性的精神疾病/社交情况；7）周围神经病变≥1级；8）治疗研究者认为会干扰研究依从性或危及患者安全、研究终点或寿命的任何其他疾病或状况； （6）正在怀孕或正在哺乳（除非患者同意停止哺乳）； （7）在登记前1年内有其他活动性恶性肿瘤病史的患者。注：这一要求的例外包括经过充分治疗的非黑色素瘤皮肤癌或恶性雀斑样痣或无疾病证据的原位癌，或复发的胶质母细胞瘤； （8）有缺血性脑病病史和/或有脑疝风险的患者； （9）接受增强磁共振成像（Magnetic Resonance Imaging，MRI）的医学禁忌证； （10）已知对碘和/或钆造影剂过敏反应的病史； （11）研究参与者在治疗后4周内接受过任何其他试验性药物，或者正在参与或计划参与另一项可能影响本试验结果的试验性试验（除非收到波士顿科学研究团队的书面批准）； （12）血管造影标测排除标准：有显著的血管疾病、显著的房室分流或 MR/CT血管造影显示的解剖扭曲妨碍了安全或可行的血管通路，或治疗计划中有功能型高危血管分布的患者； （13）脑部曾接受粒子植入治疗等放射治疗； （14）经MDT评估存在手术治疗机会者，包括：肿瘤局限、可实现最大范围安全切除；复发肿瘤为孤立病灶，切除后可带来临床获益；低级别胶质瘤初治，无进展证据且具备手术指征者。

Exclusion criteria：

(1) Tumor adjacent to or invading the brain stem; (2) Patients who had received two or more lines of systemic anti-tumor therapy, temozolomide maintenance therapy was not included in the number of treatment lines; (3) Received thoracic radiotherapy; An increased risk of wound dehistion, as judged by the investigator (e.g., brain surgery within the past 3 months, poor skin condition, and/or infection in the area of previous surgery, or any other condition considered by the neurosurgeon to increase the risk of infection); (4) Uncontrollable epilepsy; (5) With severe and/or inadequately controlled comorbidities; Patients were ineligible if they: 1) drug-poorly controlled hypertension grade 3 or higher; 2) symptomatic or unstable cardiac disease, known right-to-left shunt, or severe pulmonary hypertension (pulmonary arterial pressure >90 mmHg); 3) pulmonary insufficiency (Arterial partial pressure of oxygen (PaO?) <60 mmHg, or Arterial Oxygen Saturation, as measured by fingertip pulse oximeter; SaO?) <90%); 4) persistent or active bacterial or viral infection (including HIV) requiring systemic therapy; 5) pneumonia; 6) psychiatric/social conditions that limit adherence to study requirements; 7) peripheral neuropathy >= grade 1; 8) treat any other disease or condition that, in the opinion of the investigator, would interfere with adherence to the study or endanger patient safety, study endpoint, or life expectancy; (6) Being pregnant or breastfeeding (unless the patient agrees to stop breastfeeding); (7) Patients with a history of other active malignant tumors within 1 year before registration. Note: Exceptions to this requirement include adequately treated non-melanoma skin cancer or LM or carcinoma in situ with no evidence of disease, or recurrent glioblastoma; (8) Patients with a history of ischemic encephalopathy and/or risk of cerebral herniation; (9) Medical contraindications to enhanced Magnetic Resonance Imaging (MRI); (10) A known history of allergic reactions to iodine and/or gadolinium contrast media; (11) The study participant received any additional investigational drug within 4 weeks after treatment or was currently participating or planned to participate in another investigational trial that could affect the results of this trial (unless written approval was received from the Boston Scientific Research team); (12) Angiographic mapping exclusion criteria: patients with significant vascular disease, significant atrioventricular shunt, anatomical distortion on MR/CT angiography that prevented safe or feasible vascular access, or treatment plans with functional high-risk vascular distribution; (13) Patients had received radiation therapy such as seed implantation in the brain; (14) Patients with surgical opportunity as assessed by MDT, including limited tumor and maximally safe resection; The recurrent tumor is a solitary lesion, which can bring clinical benefit after resection. Patients with initial treatment of low-grade glioma, no evidence of progression and surgical indications.

研究实施时间：

Study execute time：

从 From 2026-05-01 00:00:00至 To 2028-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-15 00:00:00 至 To 2028-06-30 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：

钇-90树脂微球选择性内放射治疗（SIRT）

干预措施代码：

 01

Intervention：

Selective internal radiotherapy (SIRT) with yttrium-90 resin microspheres

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)：

 昌平区 

Country：

China

Province：

Beijing

City：

Changping District

单位(医院)：

 北京清华长庚医院 

单位级别：

 三级 

Institution
hospital：

Beijing Tsinghua Changgung Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

治疗相关不良事件发生率

指标类型：

主要指标

Outcome：

Incidence of treatment-related adverse events

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

技术成功率

指标类型：

主要指标

Outcome：

Technical success rate

Type：

Primary 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：

6个月生存率

指标类型：

次要指标

Outcome：

6-month survival rate

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：

无

组织：

无

Sample Name：

None

Tissue：

None

人体标本去向

 其它  

说明

本研究不涉及为科研目的额外采集或长期保存人体标本；仅进行方案规定的常规实验室检查。

Fate of sample：

0thers  

Note：

No additional human samples will be collected or stored specifically for research purposes; only routine laboratory tests required by the protocol will be performed.

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 18 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：

无

Blinding：

None

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

否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：

本研究采用病例报告表（CRF）进行数据采集与管理。研究者负责维护所有原始文件，原始记录不得随意更改；如需更正，应采用附加说明方式注明理由，并由参加临床试验的医师和研究者签名并注明日期。临床试验中实验室数据均应记录并保存原始报告单。研究过程中，研究助理将对录入CRF的数据与原始数据进行核对，发现错误或遗漏时及时反馈研究者。病史和不良事件将采用MedDRA进行编码。所有必要的研究文件，包括受试者记录、原始文件及CRFs等，均由研究中心和研究者妥善保存，并按照相关法规和数据保护要求管理。受试者在CRF及其他文件中将以姓名缩写和唯一受试者编码识别，以保护其隐私和保密性。

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

Data in this study will be collected and managed using Case Report Forms (CRFs). The investigators will be responsible for maintaining all source documents. Source records must not be altered arbitrarily; any correction must be documented by an additional note stating the reason, and signed and dated by the participating physician and investigator. Laboratory data generated during the study will be recorded and the original reports will be retained. During the study, the research assistant will compare the data entered into the CRFs with the source data and notify the investigator of any errors or omissions. Medical history and adverse events will be coded using MedDRA. All essential study documents, including participant records, source documents, and CRFs, will be properly maintained by the study center and investigators in accordance with applicable regulations and data protection requirements. Participants will be identified in CRFs and other study documents only by their initials and unique study codes to protect privacy and confidentiality.

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：

  2026-05-06 10:11:55