ChiCTR2500115704 版本V1.0 版本创建时间2025/12/30 11:35:10 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：

 ChiCTR2500115704 

最近更新日期：

Date of Last Refreshed on：

 2025-12-30 11:35:04 

注册时间：

Date of Registration：

 2025-12-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

HAIC联合姑息性TACE续贯靶向免疫治疗BCLC C期不可切除HCC的疗效及安全性研究

Public title：

Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined with Palliative Transarterial Chemoembolization Followed by Targeted Immunotherapy in Unresectable BCLC Stage C Hepatocellular Carcinoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

HAIC联合姑息性TACE续贯靶向免疫治疗BCLC C期不可切除HCC的疗效及安全性研究

Scientific title：

Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined with Palliative Transarterial Chemoembolization Followed by Targeted Immunotherapy in Unresectable BCLC Stage C Hepatocellular Carcinoma

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：

张松男 

研究负责人：

张松男 

Applicant：

Songnan Zhang 

Study leader：

Songnan Zhang 

申请注册联系人电话：

Applicant telephone：

 +86 155 2677 1553

研究负责人电话：

Study leader's
telephone：

+86 155 2677 1553

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：

 zhangsn21@163.com

研究负责人电子邮件：

Study leader's E-mail：

 zhangsn21@163.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：

吉林省延吉市局子街1327号

研究负责人通讯地址：

吉林省延吉市局子街1327号

Applicant address：

No. 1327, Juzi Street, Yanji City, Jilin Province

Study leader's address：

No. 1327, Juzi Street, Yanji City, Jilin Province

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：

延边大学附属医院

Applicant's institution：

Affiliated Hospital of Yanbian University

研究负责人所在单位：

延边大学附属医院

Affiliation of the Leader：

Affiliated Hospital of Yanbian University

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：

 20250155

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：

延边大学附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Yanbian University Affiliated Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-23 00:00:00

伦理委员会联系人：

权海燕

Contact Name of the ethic committee：

Haiyan Quan

伦理委员会联系地址：

吉林省延吉市局子街1327号

Contact Address of the ethic committee：

No. 1327, Juzi Street, Yanji City, Jilin Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 155 2677 1786

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：

延边大学附属医院

Primary sponsor：

Affiliated Hospital of Yanbian University

研究实施负责（组长）单位地址：

吉林省延吉市局子街1327号

Primary sponsor's address：

No. 1327, Juzi Street, Yanji City, Jilin Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

吉林

市(区县)：

延吉

Country：

China

Province：

Jilin

City：

单位(医院)：

延边大学附属医院

具体地址：

吉林省延吉市局子街1327号

Institution
hospital：

Affiliated Hospital of Yanbian University

Address：

No. 1327, Juzi Street, Yanji City, Jilin Province

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

BCLC C期HCC  

Target disease：

BCLC Stage C Hepatocellular Carcinoma

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：

主要研究目的： 通过评估客观缓解率（ORR）来评价HAIC联合姑息性TACE续贯靶向免疫治疗BCLC C期不可切除HCC的有效性。 次要研究目的： 通过评估无进展生存期（PFS）、肿瘤缓解程度（DpR）、总生存期（OS）评价HAIC联合姑息性TACE续贯靶向免疫治疗BCLC C期不可切除HCC的有效性。 评价HAIC联合姑息性TACE续贯靶向免疫治疗BCLC C期不可切除HCC的安全性。 探索性研究目的： 探索局部治疗联合靶向免疫治疗疗效差异的潜在机制和肿瘤免疫微环境异质性特征，包括治疗基线期、局部治疗联合靶免治疗2周期后组织样本进行单细胞测序，以描绘关键时间点免疫微环境的动态变化并挖掘决定疗效差异的核心细胞群和信号通路。同时，将结合外周血cfRNA检测，识别能够用于复发预测或预后评估的潜在生物标志物和治疗新靶点。  

Objectives of Study：

Main research objectives: The efficacy of HAIC combined with palliative TACE in sequential targeted immunotherapy for unresectable HCC in stage C of BCLC was evaluated by assessing the objective response rate (ORR). Secondary research objectives: The efficacy of HAIC combined with palliative TACE in continuous targeted immunotherapy for unresectable HCC in stage C of BCLC was evaluated by assessing progression-free survival (PFS), tumor response degree (DpR), and overall survival (OS). To evaluate the safety of HAIC combined with palliative TACE in sequential targeted immunotherapy for unresectable HCC in stage C of BCLC. The purpose of exploratory research To explore the potential mechanisms of the efficacy differences between local treatment and targeted immunotherapy and the heterogeneous characteristics of the tumor immune microenvironment, including single-cell sequencing of tissue samples during the treatment baseline period and after two cycles of local treatment combined with targeted immunotherapy, in order to depict the dynamic changes of the immune microenvironment at key time points and to identify the core cell populations and signaling pathways that determine the efficacy differences. At the same time, peripheral blood cfRNA detection will be combined to identify potential biomarkers and new therapeutic targets that can be used for recurrence prediction or prognosis assessment.

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.在实施任何试验相关流程之前，签署书面知情同意； 2.男或女性>=18 周岁； 3.经影像学或病理组织学确诊的肝细胞癌； 4.BCLC分期C期； 5.ECOG评分0-1分； 6.预期生存时间>6个月； 7.完善胃镜检查无出血风险 8.足够器官功能，受试者需满足如下实验室指标： 1)近14天未使用粒细胞集落刺激因子的情况下，中性粒细胞绝对值（ANC）>=1.5x10^9/L。 2)近14天未输血的情况下，血小板>=75×10^9/L。 3)近14天内无输血或使用促红细胞生成素的情况下，血红蛋白>9g/dL； 4)总胆红素<=1.5×正常值上限（ULN）； 5)天门冬氨酸转氨酶（AST）、丙氨酸转氨酶（ALT）在<=3×ULN、血肌酐<=1.5×ULN并且肌酐清除率（采用Cockcroft-Gault 公式计6)算）>=50 ml/min； 7)国际标准化比率（INR）≤2.3 或凝血酶原时间（PT）超过 正常对照的范围≤6 秒； 8)甲状腺功能正常，定义为促甲状腺激素（TSH）在正常范围内。如基线TSH超出正常范围，如果总T3（或FT3）及FT4在正常范围内的受试者亦可入组； 9)心肌酶谱在正常范围内（如研究者综合判断为不具有临床意义的单纯实验室异常也允许入组）； 9.对于育龄期女性受试者，应在接受首次研究药物给药（第1周期第1天）之前的3天内接受尿液或血清妊娠试验且结果为阴性。如果尿液妊娠试验结果无法确认为阴性，则要求进行血液妊娠试验。非育龄期女性定义为绝经后至少１年，或进行过手术绝育或子宫切除术； 10.如存在受孕风险，所有受试者（不论男性或女性）均需在整个治疗期间直至治疗末次研究药物给药后120天（或末次化疗药物给药后180天）内采用年失败率低于1%的避孕措施。

Inclusion criteria

Before implementing any trial-related procedures, sign a written informed consent. 2. Male or female, aged 18 or above; 3. Hepatocellular carcinoma confirmed by imaging or histopathology; 4.BCLC stage C; 5.ECOG score: 0-1 point; 6. Expected survival time >6 months; 7. There is no risk of bleeding after a complete gastroscopy 8. Sufficient organ function. The subjects need to meet the following laboratory indicators: In the absence of granulocyte colony-stimulating factor for the past 14 days, the absolute value of neutrophils (ANC) is greater than or equal to 1.5 × 10^9/L. 2) Without blood transfusion in the past 14 days, the platelet count is greater than or equal to 75×10^9/L. 3) In the past 14 days, without blood transfusion or the use of erythropoietin, the hemoglobin level is greater than 9g/dL. 4) Total bilirubin <=1.5× upper limit of normal value (ULN); 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are less than or equal to 3×ULN, serum creatinine is less than or equal to 1.5×ULN, and the creatinine clearance rate (calculated using the Cockcrot-Gault formula 6) is greater than or equal to 50 ml/min. 7) The international normalized ratio (INR) is ≤2.3 or the prothrombin time (PT) exceeds the normal control range by ≤6 seconds; 8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled. 9) The myocardial enzyme spectrum is within the normal range (if the researcher comprehensively determines that it is a simple laboratory abnormality without clinical significance, enrollment is also allowed). For female subjects of childbearing age, a urine or serum pregnancy test should be conducted within 3 days prior to the first administration of the study drug (Day 1 of cycle 1), and the result should be negative. If the result of the urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required. Women of non-childbearing age are defined as those who have been menopausal for at least one year, or have undergone surgical sterilization or hysterectomy. 10. If there is a risk of conception, all subjects (regardless of gender) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of the chemotherapy drug).

排除标准：

1.已知肝胆管细胞癌、肉瘤样肝细胞癌、肝混合细胞癌及纤 维板层细胞癌；5 年内或同时患有除肝细胞癌之外的其它活 动性恶性肿瘤。已治愈的局限性肿瘤，如皮肤基底细胞癌、 皮肤鳞癌、表浅膀胱癌、前列腺原位癌、宫颈原位癌、乳腺 原位癌等可以入组； 2.既往接受过下列疗法：抗PD-1、抗PD-L1或抗PD-L2药物或者针对另一种刺激或协同抑制T细胞受体（例如，CTLA-4、OX-40、CD137）的药物；具有抑制或阻断关键致癌信号通路的靶向药物，或能够调控肿瘤细胞生长、增殖和血管生成等分子机制的药物（例如，靶向VEGF/VEGFR通路的抗血管生成其他药物如仑伐替尼；靶向多靶点酪氨酸激酶的药物如索拉非尼、瑞戈非尼；或靶向特定基因突变的精准治疗药物如EGFR、MET、BRAF抑制剂）。 3.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）系统性全身治疗； 4.有临床症状的中度、重度腹水即需要治疗性的穿刺、引流者或 Child-Pugh 评分>7（仅影像学显示少量腹水但不伴有临床症状者除外）；不受控制或中等量及以上的胸腔积液、心包积液； 5.有肝性脑病病史者； 存在活动性自身免疫病或有自身免疫病病史且可能复发 （包括但不局限于：自身免疫性肝炎、间质性肺炎、葡萄膜炎、肠炎、垂体炎、血管炎、肾炎、甲状腺功能亢进、甲状腺功能降低[仅通过激素替代治疗可以控制的受试者可纳入]）；受试者患有无需系统治疗的皮肤病如6.白癜风、银屑病、脱发，接受胰岛素治疗的经控制的 I 型糖尿病或在童年期哮喘已完全缓解，成人后无需任何干预的可纳入；需要支气管扩张剂进行医学干预的哮喘患者则不能纳入； 7.目前伴有间质性肺炎或间质性肺病，或既往有需激素治疗的间质性肺炎或间质性肺病病史者，或其他可能干扰免疫相关肺毒性判断和处理的肺纤维化、机化性肺炎（例如，闭塞性细支气管炎）、尘肺、药物相关肺炎、特发性肺炎或在筛选期胸部计算机断层扫描（CT）图上可见活动性肺炎证据或肺功能严重受损的受试者，允许放射野曾有放射性肺炎；活动性结核； 8.已知对本研究药物贝伐珠单抗及信迪利单抗活性成分或辅料过敏者; 9.已知人类免疫缺陷病毒（HIV）感染史（即HIV 1/2抗体阳性）； 10.未经治疗的活动性乙肝（定义为HBsAg阳性同时检测到HBV-DNA拷贝数大于所在研究中心检验科正常值上限）； 注：符合下列标准的乙肝受试者亦可入组： 1)首次给药前HBV病毒载量<1000拷贝/ml（200 IU/ml），受试者应在整个研究化疗药物治疗期间接受抗HBV治疗避免病毒再激活 2)对于抗HBc（+）、HBsAg（-）、抗HBs（-）和HBV病毒载量（-）的受试者，不需要接受预防性抗HBV治疗，但是需要密切监测病毒再激活 11.活动性的HCV感染受试者（HCV抗体阳性且HCV-RNA水平高于检测下限）； 12.妊娠或哺乳期妇女； 13.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)存在需要全身性治疗的活动性或未能控制的感染； 7)存在临床活动性憩室炎、腹腔脓肿、胃肠道梗阻； 8)肝脏疾病如肝硬化、失代偿性肝病、急性或慢性活动性肝炎； 9)糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L）； 10)尿常规提示尿蛋白≥++，且证实24小时尿蛋白定量＞1.0 g者； 11)存在精神障碍且无法配合治疗的患者； 14.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. Known cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed hepatocellular–cholangiocarcinoma, or fibrolamellar carcinoma; history of any other active malignancy within the past 5 years or concurrent malignancy other than HCC. Patients with adequately treated, localized malignancies (e.g., basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast) are eligible. 2. Prior treatment with any of the following therapies:Anti–PD-1, anti–PD-L1, or anti–PD-L2 agents;Agents targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137);Targeted therapies inhibiting key oncogenic signaling pathways or regulating tumor growth, proliferation, or angiogenesis, including but not limited to anti-angiogenic agents targeting the VEGF/VEGFR pathway (e.g., lenvatinib), multi-target tyrosine kinase inhibitors (e.g., sorafenib, regorafenib), or precision therapies targeting specific gene alterations (e.g., EGFR, MET, or BRAF inhibitors). 3. Systemic treatment with traditional Chinese medicine with antitumor indications or immunomodulatory agents (including thymosin, interferons, or interleukins) within 2 weeks prior to first dosing. 4. Clinically significant moderate to severe ascites requiring therapeutic paracentesis or drainage, or Child–Pugh score > 7 (patients with minimal ascites detected only by imaging without clinical symptoms are allowed); uncontrolled or moderate-to-large pleural effusion or pericardial effusion. 5. History of hepatic encephalopathy. 6. Active autoimmune disease or history of autoimmune disease with potential for relapse, including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (patients with hypothyroidism controlled with hormone replacement therapy may be enrolled).Patients with skin disorders not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia), controlled type I diabetes mellitus on insulin, or childhood asthma completely resolved without adult intervention are eligible. Patients with asthma requiring bronchodilator therapy are excluded. 7. Current interstitial pneumonia or interstitial lung disease (ILD), or a history of ILD requiring steroid treatment; pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonitis, idiopathic pneumonia, or evidence of active pneumonia on screening chest CT; severely impaired pulmonary function. Prior radiation pneumonitis confined to the radiation field is allowed. Active tuberculosis is excluded. 8. Known hypersensitivity to bevacizumab, sintilimab, or any excipients of the study drugs. 9. Known history of human immunodeficiency virus (HIV) infection (HIV-1/2 antibody positive). 10.Untreated active hepatitis B infection, defined as HBsAg positivity with detectable HBV-DNA levels above the upper limit of normal at the local laboratory. Note: Patients meeting the following criteria may be enrolled:HBV DNA < 1,000 copies/mL (200 IU/mL) prior to first dosing, with mandatory antiviral therapy throughout chemotherapy to prevent viral reactivation;Patients who are anti-HBc positive, HBsAg negative, anti-HBs negative, and HBV DNA negative do not require prophylactic antiviral therapy but must be closely monitored for viral reactivation. 11. Active hepatitis C infection (HCV antibody positive with HCV-RNA levels above the lower limit of detection). 12. Pregnant or breastfeeding women. 13. Presence of any severe or uncontrolled systemic disease, including but not limited to: 1) Clinically significant and uncontrolled abnormalities on resting ECG, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmias, or atrial fibrillation; 2) Unstable angina, congestive heart failure, or chronic heart failure classified as NYHA class ≥ II; 3) Arterial thrombotic, embolic, or ischemic events within 6 months prior to enrollment, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; 4) Poorly controlled hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg); 5) History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year prior to first dosing, or current clinically active ILD; 6) Active or uncontrolled infection requiring systemic therapy; 7) Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction; 8) Liver diseases such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis; 9) Poorly controlled diabetes mellitus (fasting blood glucose > 10 mmol/L); 10) Urinalysis showing proteinuria ≥ 2+, confirmed by 24-hour urinary protein excretion > 1.0 g; 11) Psychiatric disorders that may interfere with compliance with study treatment. 14. Any medical history, disease, treatment, or abnormal laboratory finding that may interfere with study results, prevent full participation in the study, or pose additional risk to the participant, as judged by the investigator.

研究实施时间：

Study execute time：

从 From 2025-12-24 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-30 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 30

Group：

Experimental Group

Sample size：

干预措施：

HAIC联合姑息性TACE续贯靶向免疫治疗

干预措施代码：

Intervention：

HAIC–palliativeTACE sequential targeted immunotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 吉林 

市(区县)：

 延吉 

Country：

China

Province：

Jilin

City：

Yanji

单位(医院)：

 延边大学附属医院 

单位级别：

 三级甲等 

Institution
hospital：

Affiliated Hospital of Yanbian University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

客观缓解率

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

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：

肿瘤缓解深度

指标类型：

次要指标

Outcome：

Depth of Response, DpR

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

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：

不良事件

指标类型：

次要指标

Outcome：

Adverse Events,AEs

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：

影像学可测量病灶

组织：

Sample Name：

The lesion can be measured by imaging

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：

肝细胞癌组织样本

组织：

Sample Name：

Hepatocellular carcinoma tissue samples

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction 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 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：

CRF

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

CRF

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：

  2025-12-30 11:35:04