ChiCTR2600121235 版本V1.0 版本创建时间2026/03/27 08:41:44 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：

ChiCTR2600121235 

最近更新日期：

Date of Last Refreshed on：

2026-03-27 08:41:37 

注册时间：

Date of Registration：

2026-03-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

多柔比星联合安罗替尼用于I-II期高级别子宫体肉瘤术后辅助治疗的开放、单臂、探索性临床研究

Public title：

Doxorubicin plus anlotinib for the adjuvant treatment of stage I–II high-grade uterine sarcoma: a single-arm exploratory study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

多柔比星联合安罗替尼用于I-II期高级别子宫体肉瘤术后辅助治疗的开放、单臂、探索性临床研究

Scientific title：

Doxorubicin plus anlotinib for the adjuvant treatment of stage I–II high-grade uterine sarcoma: a single-arm exploratory study

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：

王宜生 

研究负责人：

王宜生 

Applicant：

Wang Yisheng 

Study leader：

Wang Yisheng 

申请注册联系人电话：

Applicant telephone：

+86 21 33189900

研究负责人电话：

Study leader's telephone：

+86 21 33189900

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：

wangyisheng1758@fckyy.org.cn

研究负责人电子邮件：

Study leader's E-mail：

wangyisheng1758@fckyy.org.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：

中国上海市黄浦区方斜路419号

研究负责人通讯地址：

中国上海市黄浦区方斜路419号

Applicant address：

419 Fangxie Road, Huangpu District, Shanghai, China

Study leader's address：

419 Fangxie Road, Huangpu District, Shanghai, 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：

复旦大学附属妇产科医院

Applicant's institution：

Obstetrics and Gynecology Hospital Affiliated to Fudan University

研究负责人所在单位：

复旦大学附属妇产科医院

Affiliation of the Leader：

Obstetrics and Gynecology Hospital Affiliated to Fudan 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：

妇产科伦审 2025-279

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：

复旦大学附属妇产科医院伦理委员会

Name of the ethic committee：

Ethics Committee of Obstetrics ＆ Gynecology Hospital of Fudan University

伦理委员会批准日期：

Date of approved by ethic committee：

2026-01-19 00:00:00

伦理委员会联系人：

袁谢华

Contact Name of the ethic committee：

Yuan Xiehua

伦理委员会联系地址：

中国上海市黄浦区方斜路419号

Contact Address of the ethic committee：

419 Fangxie Road, Huangpu District, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 33189900

伦理委员会联系人邮箱：

Contact email of the ethic committee：

2235192550@qq.com

研究实施负责（组长）单位：

复旦大学附属妇产科医院

Primary sponsor：

Obstetrics and Gynecology Hospital Affiliated to Fudan University

研究实施负责（组长）单位地址：

中国上海市黄浦区方斜路419号

Primary sponsor's address：

419 Fangxie Road, Huangpu District, Shanghai, 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(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

复旦大学附属妇产科医院

具体地址：

中国上海市黄浦区方斜路419号

Institution
hospital：

Obstetrics and Gynecology Hospital Affiliated to Fudan University

Address：

419 Fangxie Road, Huangpu District, Shanghai, China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected topic (self-funded)

Target disease：

Uterine sarcoma

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：

本研究将评价多柔比星联合安罗替尼，后续安罗替尼维持，用于I-II期经手术完整切除的高级别子宫肉瘤的术后辅助治疗的疗效，包括： 1 利用RECIST1.1评估的无进展生存期（PFS） 2 总生存期（OS）  

Objectives of Study：

This study will evaluate the efficacy of doxorubicin combined with anlotinib, followed by anlotinib maintenance, for postoperative adjuvant treatment of high-grade uterine sarcoma at stage I-II that has undergone complete surgical resection, including: 1. Progression-free survival (PFS) as assessed by RECIST1.1 2. Overall survival (OS)

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. 签署书面知情同意书（Informed Consent Form, ICF），而且能够遵守方案规定的访视及相关程序。 2. 女性受试者，年龄>=18 岁。 3. 预期生存时间>=12 周。 4. 美国东部肿瘤协作组体力状态评分（Eastern Cooperative Oncology Group Performance Status, ECOG PS）为 0 或 1 分。 5. 经组织学确证的子宫体高级别肉瘤，包括子宫平滑肌肉瘤、高级别子宫内膜间质肉瘤、未分化子宫肉瘤。 6. 已接收根治性全子宫切除（如肿瘤雌激素受体阳性，应切除双侧卵巢），并切除所有盆腹腔可见转移病灶，且病理确认切缘阴性；术后无肉眼可见残留病灶。 7. 根据影像及病理，肿瘤分期为I-II期（AJCC，2017）。 8. 首次研究用药距根治性手术时间在4周以内。 9. 首次研究用药前 28 天内左心室射血分数（Left Ventricular Ejection Fraction, LVEF）>=50%。 10. 具有充分的骨髓和器官功能，研究药物首次给药前 7 天内实验室检查值符合下列要求（若筛选期进行的实验室检查不符合下方要求，只允许在筛选期复测 1 次。在接受实验室检查前 7 天内不允许使用任何细胞、血液成分、集落刺激因子及细胞因子治疗）： (1) 血常规：绝对中性粒细胞计数（Absolute Neutrophil Count, ANC）>=1.5×10^9/L 或正常范围内；血小板计数（platelet，PLT）>=75×10^9/L；血红蛋白（hemoglobin，HGB）>=80 g/L。 (2) 肝功能：总胆红素（Total Bilirubin，TBIL）<=1.5×正常值上限（upper limit of normal, ULN）；如果为 Gilbert 综合征受试者，TBIL<=3×ULN；对于无肝转移的受试者，AST 和 ALT<=2.5×ULN；对于存在肝转移的受试者，AST 和 ALT<=5×ULN；白蛋白（albumin，ALB）>=28 g/L。 (3) 肾功能：血清肌酐（Cr）<=1.5×ULN 或肌酐清除率（Creatinine Clearance Rate，CCR）>=60 mL/min（使用 Cockcroft-Gault 公式计算或测量 24 小时尿液采集量计算）；尿常规提示尿蛋白＜2+，对基线时尿常规检测显示尿蛋白>=2+ 的受试者，应进行 24 小时尿液采集且 24 小时内尿液中的蛋白含量＜1g（如果两种检测方法都被采用，则将使用 24 小时尿液采集测得的数值用于确定资格）。 (4) 凝血功能：国际标准化比值（International Normalized Ratio，INR）<=1.5；活化部分凝血活酶时间（Activated Partial Thromboplastin Time，APTT）<=1.5×ULN。

Inclusion criteria

1. Signed and dated the written Informed Consent Form (ICF) prior to any study-specific procedures, and is able to comply with the protocol-scheduled visits and related procedures. 2. Female subjects, aged >=18 years. 3. Life expectancy >=12 weeks. 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 5. Histologically confirmed high-grade uterine sarcoma, including uterine leiomyosarcoma, high-grade endometrial stromal sarcoma, and undifferentiated uterine sarcoma. 6. Has undergone total hysterectomy (bilateral oophorectomy should be performed if the tumor is estrogen receptor positive), resection of any visible intra-abdominal and pelvic metastases, and pathologically confirmed negative surgical margins; no gross residual disease post-surgery. 7. Tumor stage I-II based on imaging and pathology (AJCC, 2017). 8. The time interval between the first dose of study drug and surgery is within 4 weeks. 9. Left Ventricular Ejection Fraction (LVEF) >=50% within 28 days prior to the first dose of study drug. 10. Adequate bone marrow and organ function, with laboratory values meeting the following requirements within 7 days prior to the first dose of study drug (if laboratory tests performed during the screening period do not meet the requirements below, re-testing is allowed only once during the screening period. No cellular, blood component, colony-stimulating factor, or cytokine therapy is allowed within 7 days prior to laboratory testing): (1) Hematology: Absolute Neutrophil Count (ANC) >=1.5×10^9/L or within normal range; Platelet Count (PLT) >=75×10^9/L; Hemoglobin (HGB) >=80 g/L. (2) Hepatic Function: Total Bilirubin (TBIL) <=1.5×Upper Limit of Normal (ULN); for subjects with Gilbert's syndrome, TBIL <=3×ULN; for subjects without liver metastases, AST and ALT <=2.5×ULN; for subjects with liver metastases, AST and ALT <=5×ULN; Albumin (ALB) >=28 g/L. (3) Renal Function: Serum Creatinine (Cr) <=1.5×ULN or Creatinine Clearance Rate (CCR) >=60 mL/min (calculated using the Cockcroft-Gault formula or measured via 24-hour urine collection); Urinalysis indicates protein <2+. For subjects with baseline urinalysis protein >=2+, a 24-hour urine collection should be performed and urine protein should <1g/24h (if both methods are used, the value from the 24-hour urine collection will be used to determine eligibility). (4) Coagulation Function: International Normalized Ratio (INR) <=1.5; Activated Partial Thromboplastin Time (APTT) <=1.5×ULN.

排除标准：

1. 组织学或细胞学检查结果满足以下条件中的任意一个：证实为癌肉瘤，低级别子宫内膜间质肉瘤，血管周围上皮样细胞瘤。 2. 参与任何其他干预性临床研究，观察性（非干预性）研究或处于干预性研究的研究治疗结束后的随访期除外。 3. 在研究药物首次给药前：(1) 4 周内接受过静脉输注化疗药物、大分子靶向药物、抗体偶联药物、免疫治疗、内分泌治疗、细胞治疗、腹腔灌注化疗、肿瘤栓塞术或介入化疗等。(2) 2 周或 5 个半衰期（以较长者为准）内接受过口服化疗药物、小分子靶向药物和以抗肿瘤治疗为适应症的中草药。(3) 4 周内接受过根治性放射治疗；2 周内接受过姑息性放射治疗。(4) 4 周内接受过活疫苗（mRNA 和非复制型腺病毒疫苗不视为活疫苗）接种。 4. 存在既往抗肿瘤治疗引起的不良反应，且根据 NCI-CTCAE v5.0 标准在入组前尚未缓解至 0 级或 1 级【2 级脱发、乏力、色素沉着、失眠、周围神经病变、低镁血症、经药物控制稳定的毒性（如经替代治疗稳定控制的甲状腺功能功能减退、经降压药物治疗血压稳定控制在 160/100 mmHg 以下的高血压）等除外】。 5. 有需要皮质类固醇治疗的肺炎，或有其他有临床意义的肺部疾病史（例如间质性肺疾病，非感染性肺炎），或不受控制的肺部疾病（例如肺纤维化、严重的放射性肺炎和急性肺损伤）或筛选期通过影像学检查怀疑患有此类疾病的受试者。 6. 未受控制或显著的心脑血管疾病，包括下列情况：(1) 未受控制的心肌炎，或症状性充血性心力衰竭 II-IV 级（纽约心脏协会[NYHA]标准），症状性或未受控制的心律失常例如室性心动过速、心房颤动、心室纤维性颤动、尖端扭转性室速等。(2) 采用 Fridericia 法校正的 QT 间期（QTcF）＞480 ms，有先天性长/短 QT 综合征的个人或家族史。若筛选期 1 次心电图检测的 QTcF＞480 ms，需连续测 3 次心电图并计算 QTcF 的平均值，若仍＞480 ms 不予入组。(3) 首次开始研究治疗前 6 个月内发生过任何动脉血栓栓塞事件史，包括心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作等。(4) 在首次接受研究药物给药前 3 个月内有深静脉血栓形成、肺栓塞或任何其他严重血栓栓塞病史（由植入式静脉输液港导致的血栓或导管源性血栓，或浅表静脉血栓形成不被视为严重血栓栓塞）。(5) 未接受规范治疗或即使给予规范治疗仍然未受控制的高血压（收缩压>=160mmHg 或舒张压>=100mmHg）。 7. 需要立即进行干预（例如结扎或硬化疗法）的食管或胃静脉曲张，或者研究者或胃肠病学和肝病学专家认为存在较高的出血风险，有门静脉高压证据（包括影像学检查发现脾大）或既往有静脉曲张出血病史的受试者在首次开始研究治疗前 3 个月内必须接受内镜评估。 8. 未愈的消化道梗阻、穿孔或瘘管，或有消化道梗阻或穿孔风险的受试者（包括但不限于急性憩室炎、腹腔脓肿），或存在以下疾病史：广泛肠切除（部分结肠切除或广泛小肠切除，并发慢性腹泻）、克罗恩氏病、溃疡性结肠炎或慢性腹泻。注：消化道指自口腔至肛管的肌性管道，包括口腔、咽、食道、胃、小肠（十二指肠、空肠、回肠）、大肠（盲肠、阑尾、结肠、直肠）和肛管等部位。 9. 消化道或气管腔内支架植入术后。 10. 患有胆道梗阻的受试者，除非已针对梗阻进行过局部治疗（如内镜下支架置入术或经皮肝穿刺引流术），且 TBIL 已降至 1.5 倍 ULN 以下。 11. 肝性脑病，肝肾综合征或 Child-Pugh B 级或以上的肝硬化。 12. 显著的营养不良，如因营养不良需要静脉补充营养液；首次开始研究治疗前 4周以内未使用静脉营养液者除外。 13. 未受控制的活动性感染，包括下列情况：(1) 存在需要系统性抗生素、抗病毒药物或抗真菌药物治疗的感染。(2) 人类免疫缺陷病毒（Human Immunodeficiency Virus, HIV）感染（HIV 1/2 Ab 阳性）。(3) 活动性结核感染，或仍在接受抗结核治疗，或在研究药物首次给药前 1 年内接受过抗结核治疗。 14. ECOG评分>=2分。 15. 首次开始研究治疗前 3 年内合并其他原发恶性肿瘤或存在其他具有活动性或复发风险的恶性肿瘤，不包括经过根治的皮肤基底细胞癌、皮肤鳞状细胞癌、经过根治切除的原位癌和甲状腺乳头状癌。 16. 有免疫缺陷疾病史，包括先天性或获得性免疫缺陷疾病。 17. 异体器官移植、同种异体骨髓移植或自体造血干细胞移植史（角膜移植除外）。 18. 存在其他可能会增加研究参与或给药风险的、干扰研究结果解读的、或致使研究者判断其不适合参与研究的急性或慢性疾病或实验室检查异常。 19. 受试者存在影响试验依从性、显著增加不良事件风险或影响受试者提供书面知情同意的神经、精神或社会状况。

Exclusion criteria：

1. Histological or cytological findings meeting any of the following conditions: (1) Confirmed carcinosarcoma, low-grade endometrial stromal sarcoma, or perivascular epithelioid cell tumor (PEComa). 2. Participation in any other interventional clinical study; subjects in the follow-up period after the end of study treatment in an interventional study or in an observational (non-interventional) study are excluded. 3. Prior to the first dose of study drug: (1) Received intravenous chemotherapy, macromolecular targeted drugs, antibody-drug conjugates, immunotherapy, endocrine therapy, cell therapy, intraperitoneal chemotherapy, tumor embolization, or interventional chemotherapy within 4 weeks. (2) Received oral chemotherapy, small molecule targeted drugs, and Chinese herbal medicine with anti-tumor indications within 2 weeks or 5 half-lives (whichever is longer). (3) Received radical radiotherapy within 4 weeks; palliative radiotherapy within 2 weeks. (4) Received live vaccines (mRNA and non-replicating adenovirus vaccines are not considered live vaccines) within 4 weeks. 4. Adverse events caused by previous anti-tumor treatments that have not resolved to Grade 0 or 1 according to NCI-CTCAE v5.0 criteria prior to enrollment [excluding Grade 2 alopecia, fatigue, pigmentation, insomnia, peripheral neuropathy, hypomagnesemia, and toxicities stably controlled by medication (e.g., hypothyroidism stably controlled by replacement therapy, hypertension stably controlled below 160/100 mmHg by antihypertensive drugs)]. 5. Pneumonitis requiring corticosteroid therapy, or history of other clinically significant pulmonary diseases (e.g., interstitial lung disease, non-infectious pneumonia), or uncontrolled pulmonary diseases (e.g., pulmonary fibrosis, severe radiation pneumonitis, and acute lung injury), or subjects suspected of having such diseases via imaging during the screening period. 6. Uncontrolled or significant cardiovascular and cerebrovascular diseases, including the following: (1) Uncontrolled myocarditis, or symptomatic congestive heart failure Class II-IV (New York Heart Association [NYHA] criteria), symptomatic or uncontrolled arrhythmias such as ventricular tachycardia, atrial fibrillation, ventricular fibrillation, torsades de pointes, etc. (2) QT interval corrected by Fridericia's formula (QTcF) >480 ms, or personal or family history of congenital long/short QT syndrome. If a single ECG test during screening shows QTcF >480 ms, 3 consecutive ECGs are required to calculate the mean QTcF; if still >480 ms, the subject will not be enrolled. (3) History of any arterial thromboembolic events, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to the first study treatment. (4) History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months prior to the first dose of study drug (thrombosis caused by implanted venous access ports or catheters, or superficial vein thrombosis are not considered severe thromboembolism). (5) Uncontrolled hypertension despite standard treatment (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg). 7. Esophageal or gastric varices requiring immediate intervention (e.g., ligation or sclerotherapy), or subjects deemed by the investigator or gastroenterology/hepatology experts to be at high risk of bleeding. Subjects with evidence of portal hypertension (including splenomegaly found on imaging) or history of variceal bleeding must undergo endoscopic evaluation within 3 months prior to the first study treatment. 8. Unhealed gastrointestinal obstruction, perforation, or fistula, or subjects at risk of gastrointestinal obstruction or perforation (including but not limited to acute diverticulitis, abdominal abscess), or history of the following conditions: extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea. Note: The gastrointestinal tract refers to the muscular canal from the oral cavity to the anal canal, including the mouth, pharynx, esophagus, stomach, small intestine (duodenum, jejunum, ileum), large intestine (cecum, appendix, colon, rectum), and anal canal. 9. Post-implantation of gastrointestinal or tracheal lumen stents. 10. Subjects with biliary obstruction, unless local treatment (e.g., endoscopic stenting or percutaneous transhepatic drainage) has been performed for the obstruction and TBIL has decreased to below 1.5× ULN. 11. Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis of Child-Pugh Class B or higher. 12. Significant malnutrition, such as requiring intravenous nutritional supplementation due to malnutrition; except for those who have not used intravenous nutrition within 4 weeks prior to the first study treatment. 13. Uncontrolled active infection, including the following: (1) Presence of infection requiring systemic antibiotic, antiviral, or antifungal therapy. (2) Human Immunodeficiency Virus (HIV) infection (HIV 1/2 Ab positive). (3) Active tuberculosis infection, or currently receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year prior to the first dose of study drug. 14. ECOG score >=2. 15. Concurrent other primary malignancies within 3 years prior to the first study treatment, or presence of other malignancies with activity or risk of recurrence, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ treated with radical resection, and papillary thyroid carcinoma. 16. History of immunodeficiency diseases, including congenital or acquired immunodeficiency diseases. 17. History of allogeneic organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation (except for corneal transplantation). 18. Presence of other acute or chronic diseases or laboratory abnormalities that may increase the risk of study participation or drug administration, interfere with the interpretation of study results, or lead the investigator to judge the subject as unsuitable for participation. 19. Neurological, psychiatric, or social conditions in the subject that affect trial compliance, significantly increase the risk of adverse events, or affect the subject's ability to provide written informed consent.

研究实施时间：

Study execute time：

从 From 2026-04-01 00:00:00至 To 2028-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-04-01 00:00:00 至 To 2028-04-01 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

43

Group：

Trial group

Sample size：

干预措施：

多柔比星 75mg/m^2，每 3 周为一个治疗周期，每周期第 1 天进行静脉输注，共 4 个疗程；随后安罗替尼 8mg qd，每 3 周为一个治疗周期，每周期第 1-14 天进行口服，共 38 个疗程（维持期）

干预措施代码：

Intervention：

Doxorubicin 75 mg/m^2, intravenous infusion on day 1 of each cycle, every 3 weeks for 4 cycles; followed by Anruotini 8 mg once daily orally for days 1-14 of each cycle, every 3 weeks for 38 cycles (maintenance phase)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

复旦大学附属妇产科医院 

单位级别：

三级甲等 

Institution
hospital：

Obstetrics and Gynecology Hospital Affiliated to Fudan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

无进展生存期（PFS）

指标类型：

主要指标

Outcome：

Progression-Free Survival

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（OS）

指标类型：

主要指标

Outcome：

Overall Survival

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（AE）发生率

指标类型：

次要指标

Outcome：

Incidence of Adverse Events

Type：

Secondary indicator

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（SAE）发生率

指标类型：

次要指标

Outcome：

Incidence of Serious Adverse Events

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

AE/SAE 导致治疗终止的发生率

指标类型：

次要指标

Outcome：

Incidence of Treatment Discontinuation Due to Adverse Events/Serious Adverse Events

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：

Sample Name：

NA

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：

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：

女性

Gender：

Female

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:

不公开/Private

盲法：

无

Blinding：

None

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）：

不共享

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

Do not share

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：

病历记录表

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

Case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-03-27 08:41:37