ChiCTR2600126018 版本V1.0 版本创建时间2026/06/02 15:24:30 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：

ChiCTR2600126018 

最近更新日期：

Date of Last Refreshed on：

2026-06-02 15:22:59 

注册时间：

Date of Registration：

2026-06-02 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

芦康沙妥珠单抗联合塔戈利单抗治疗CDK4/6抑制剂经治的PD-L1阳性HR阳性/HER2阴性晚期乳腺癌的II期研究

Public title：

Phase II Study of Sacituzumab Tirumotecan in Combination with Tagitanlimab for PD-L1–Positive, HR-Positive/HER2-Negative Advanced Breast Cancer Previously Treated with CDK4/6 Inhibitors

注册题目简写：

English Acronym：

研究课题的正式科学名称：

芦康沙妥珠单抗联合塔戈利单抗治疗CDK4/6抑制剂经治的PD-L1阳性HR阳性/HER2阴性晚期乳腺癌的II期研究

Scientific title：

Phase II Study of Sacituzumab Tirumotecan in Combination with Tagitanlimab for PD-L1–Positive, HR-Positive/HER2-Negative Advanced Breast Cancer Previously Treated with CDK4/6 Inhibitors

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：

徐菲 

研究负责人：

徐菲 

Applicant：

Xu Fei 

Study leader：

Xu Fei 

申请注册联系人电话：

Applicant telephone：

+86 13711277870

研究负责人电话：

Study leader's telephone：

+86 20 87342693

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：

xufei@sysucc.org.cn

研究负责人电子邮件：

Study leader's E-mail：

xufei@sysucc.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：

中国广东省广州市越秀区东风东路651号

研究负责人通讯地址：

中国广东省广州市越秀区东风东路651号

Applicant address：

651 Dongfeng East Road, Yuexiu District, Guangzhou, Guangdong, China

Study leader's address：

651 Dongfeng East Road, Yuexiu District, Guangzhou, Guangdong, 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：

中山大学肿瘤防治中心(中山大学附属肿瘤医院中山大学肿瘤研究所)

Applicant's institution：

Sun Yat-sen University Cancer Center (Sun Yat-sen University Tumor Hospital, Sun Yat-sen University Institute of Oncology)

研究负责人所在单位：

中山大学肿瘤防治中心(中山大学附属肿瘤医院、中山大学肿瘤研究所)

Affiliation of the Leader：

Sun Yat-sen University Cancer Center (Sun Yat-sen University Tumor Hospital, Sun Yat-sen University Institute of Oncology)

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：

B2025-416-01

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：

中山大学肿瘤防治中心伦理委员会

Name of the ethic committee：

Ethics Committee of Sun Yat-sen University Cancer Center

伦理委员会批准日期：

Date of approved by ethic committee：

2025-07-09 00:00:00

伦理委员会联系人：

潘旭芝

Contact Name of the ethic committee：

Pan Xuzhi

伦理委员会联系地址：

中国广东省广州市越秀区东风东路651号

Contact Address of the ethic committee：

651 Dongfeng East Road, Yuexiu District, Guangzhou, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 87343009

伦理委员会联系人邮箱：

Contact email of the ethic committee：

panxzh@sysucc.org.cn

研究实施负责（组长）单位：

中山大学肿瘤防治中心(中山大学附属肿瘤医院、中山大学肿瘤研究所)

Primary sponsor：

Sun Yat-sen University Cancer Center (Sun Yat-sen University Tumor Hospital, Sun Yat-sen University Institute of Oncology)

研究实施负责（组长）单位地址：

中国广东省广州市越秀区东风东路651号

Primary sponsor's address：

651 Dongfeng East Road, Yuexiu District, Guangzhou, Guangdong, 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)：

广东

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

中山大学肿瘤防治中心(中山大学附属肿瘤医院、中山大学肿瘤研究所)

具体地址：

中国广东省广州市越秀区东风东路651号

Institution
hospital：

Sun Yat-sen University Cancer Center (Sun Yat-sen University Tumor Hospital, Sun Yat-sen University Institute of Oncology)

Address：

651 Dongfeng East Road, Yuexiu District, Guangzhou, Guangdong, China

经费或物资来源：

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Source(s) of funding：

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Target disease：

PD-L1+, HR+/HER2- metastatic breast cancer who previously treated with CDK4/6 inhibitor

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： 评估芦康沙妥珠单抗联合塔戈利单抗治疗CDK4/6i经治的PD-L1阳性HR+/HER2-晚期乳腺癌患者的6个月无进展生存期（PFS）率，由研究者基于实体瘤疗效评价标准1.1版（RECIST v1.1）进行评估。 次要目的： 1.评估芦康沙妥珠单抗联合塔戈利单抗治疗CDK4/6i经治的PD-L1阳性HR+/HER2-晚期乳腺癌患者的PFS、客观缓解率（ORR）、疾病控制率（DCR）、缓解持续时间（DoR）、总生存期（OS），由研究者基于实体瘤疗效评价标准1.1版（RECIST v1.1）进行评估。 2.评估芦康沙妥珠单抗联合塔戈利单抗的安全性和耐受性。 探索性目的： 1.评估肿瘤组织TROP2表达水平与疗效的相关性； 2.评估肿瘤组织PD-L1表达水平与疗效的相关性。  

Objectives of Study：

Primary Objective:To evaluate the 6-month progression-free survival (PFS) rate of Sacituzumab Tirumotecan combined with Tagitanlimab in patients with PD-L1-positive, HR+/HER2- advanced breast cancer who previously treated with CDK4/6 inhibitor, as assessed by investigators based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).Secondary Objectives:To evaluate progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and overall survival (OS) of Sacituzumab Tirumotecan combined with Tagitanlimab in patients with PD-L1-positive, HR+/HER2- advanced breast cancer who have received prior CDK4/6i treatment, as assessed by investigators based on RECIST v1.1.To evaluate the safety and tolerability of Sacituzumab Tirumotecan combined with Tagitanlimab.Exploratory Objectives:To assess the correlation between TROP2 expression level in tumor tissues and therapeutic efficacy;To assess the correlation between PD-L1 expression level in tumor tissues and therapeutic efficacy.

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. 签署知情同意书时年龄为>=18岁且<=75岁，性别不限； 2. 基于最近一次病理标本的病理报告，组织学和/或细胞学证实为HR+/HER2- BC，同时满足以下条件： (1) 病理分型为HR+/HER2-，HER2-的定义：IHC为0或1+；如果IHC为2+，则经FISH确认阴性；HR+的定义：ER和/或PR经IHC检查显示>=1%； (2) 肿瘤分期：局部晚期、复发或转移性HR+/HER2- BC；局部晚期需经研究者确认无法进行根治性手术切除； 3. 在以CDK4/6抑制剂为基础的辅助内分泌治疗治疗期间或CDK4/6抑制剂结束后12个月内出现疾病进展，或CDK4/6抑制剂治疗转移性疾病出现疾病进展； 4. PD-L1阳性（CPS>=1）； 5. 根据RECIST v1.1，由研究者评估至少具有一个可测量的靶病灶，仅有骨病灶的受试者不可纳入； 6. 给药前7天内美国东部肿瘤协作组（ECOG）体能状态评分为0或1分（详见附件2），预期生存期>=12周； 7. 具有充分的器官和骨髓功能（首次给药前2周内未接受过输血、重组人促血小板生成素或集落刺激因子治疗），定义如下： (1) 血常规：中性粒细胞计数（NEUT#）>=1.5×10^9/L；血小板（PLT）>=100×10^9/L；血红蛋白>=90g/dL； (2) 肝功能：天门冬氨酸氨基转移酶（AST）、丙氨酸氨基转移酶（ALT）、碱性磷酸酶（ALP）<=2.5×正常值上限（ULN）；总胆红素（TBIL）<=1.5×ULN；对于有肝转移患者，ALT和AST<=5×ULN，TBIL<=2×ULN；对于有肝转移或骨转移患者，ALP<=5×ULN； (3) 肾功能：肌酐清除率（Ccr）>=60 ml/min（Cockcroft-Gault公式见附件3）； (4) 凝血功能：国际标准化比值（INR）、活化部分凝血活酶时间（APTT）和凝血酶原时间（PT）<=1.5×ULN； 8. 对于具有生育能力的女性受试者和伴侣具有生育潜力的男性受试者，自签署知情同意书开始至末次给药后6个月内须同意采取有效的医学避孕措施（详见附件4）； 9. 受试者自愿加入本研究，签署知情同意书，并且能够遵守方案规定的访视及相关程序。

Inclusion criteria

1. 18-75 years old; 2. HR+/HER2- breast cancer (BC), meeting the following conditions: (1) HR+/HER2-; 1. HER2- (IHC 0 or 1+); 2. IHC 2+ (FISH negative); 3. HR+ (ER and/or PR IHC showed >=1%); (2) Tumor stage: Locally advanced, recurrent, or metastatic HR+/HER2- breast cancer; 3. Disease progression during or within 12 months after completion of adjuvant endocrine therapy based on a CDK4/6 inhibitor, or disease progression on CDK4/6 inhibitor treatment for metastatic disease; 4. PD-L1 positive (CPS >= 1); 5. At least one measurable target lesion as assessed by the investigator per RECIST 1.1; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 7. Life expectancy more than 12 weeks; 8. Adequate organ function, defined as: (1) Complete blood count: Neutrophil count >= 1.5×10^9/L; 2. Platelets >= 100×10^9/L; 3. Hemoglobin >= 9 g/dL; (2) Liver function: AST, ALT, and ALP <= 2.5× ULN; 4. Total bilirubin <= 1.5× ULN; 5. ALT and AST <= 5× ULN, TBIL <= 2× ULN for patients with liver metastases; 6. ALP <= 5× ULN for patients with liver or bone metastases; (3) Renal function: Creatinine clearance >= 60 ml/min (Cockcroft-Gault formula); (4) Coagulation function: INR, APTT, and PT <= 1.5× ULN; (5) Cardiac function: ECHO or MUGA scan indicating LVEF >= 50%; 9. For female participants of childbearing potential and male participants with reproductive potential, effective medical contraceptive measures must be implemented from the time of signing the informed consent until six months after the last administration; 10. Voluntary participation in the study with signed informed consent, demonstrated good compliance, and willingness to follow up as required.

排除标准：

1. 晚期阶段接受过下列任何一种治疗： (1) 化疗； (2) 含靶向拓扑异构酶Ⅰ的任何药物治疗，包括抗体偶联药物（ADC）治疗； (3) 免疫检查点抑制剂（如：抗 PD-1/L1 抗体、抗 CTLA-4 抗体等）、免疫检查点激动剂（如：ICOS、CD40、CD137、GITR、OX40 抗体等）、免疫细胞治疗等任何针对肿瘤免疫作用机制的治疗； 2. 早期阶段的末次化疗时间不到 12 个月出现复发转移； 3. 中枢神经系统（CNS）转移的受试者。对于既往接受过局部治疗的脑转移受试者，如果在用药前至少 4 周临床稳定并且至少 14 天内无需使用糖皮质激素或抗惊厥药物可允许入组； 4. 在给药前 5 年内患有其他恶性肿瘤（已通过局部治疗治愈的肿瘤除外，例如皮肤基底细胞癌、皮肤鳞状细胞癌、宫颈原位癌等）； 5. 存在下列任何心脑血管疾病或者心脑血管风险因素： (1) 给药前 6 个月内，发生心肌梗塞、不稳定型心绞痛、急性或持续性的心肌缺血、3 级或 4 级的心力衰竭【按照美国纽约心脏病学会（NYHA）分级（详见附件 5）】、症状性或控制不佳的严重心律失常，脑血管意外、短暂性脑缺血发作等其他严重的心脑血管疾病； (2) 既往有心肌炎、原发性心肌病、特异性心肌病等心肌疾病史； (3) 给药前 3 个月内有任何深静脉血栓（如果经过低分子肝素或类似功效药物治疗稳定>=2 周，可允许入组）、外周动脉血栓栓塞事件、肺栓塞或其他严重的血栓栓塞事件； (4) 存在主动脉瘤、主动脉夹层动脉瘤等可能危及生命或给药前 6 个月内需要手术的重大血管疾病； 6. 根据研究者判断，无法控制的系统性疾病： (1) 控制不佳的糖尿病（连续两次空腹血糖>=10mmol/L）； (2) 控制不佳的高血压（收缩压>160 mmHg 和/或舒张压>100 mmHg）； (3) 存在有临床症状或需要反复引流的胸腔积液、心包积液或腹水（>1 次/周）； 7. 存在需要类固醇治疗的（非感染性）间质性肺病（ILD）或非感染性肺炎病史，目前有 ILD 或非感染性肺炎，或筛选时存在无法经影像学检查排除的可疑 ILD 或非感染性肺炎； 8. 肺部并发疾病导致的临床严重肺损害，包括但不限于任何基础肺部疾病（如给药前 3 个月内的肺栓塞、严重哮喘、重度慢性阻塞性肺疾病、限制性肺疾病、胸腔积液等）或任何可能累及肺部的自身免疫、结缔组织或炎性疾病（即类风湿关节炎、干燥综合征、结节病等），或既往全肺切除术； 9. 患有活动性慢性炎症性肠病、胃肠道梗阻、严重溃疡、胃肠穿孔、腹腔脓肿或急性胃肠道出血的受试者； 10. 肿瘤侵犯或压迫周围重要脏器及血管（如心脏、食管、上腔静脉等）且伴随相关症状（如上腔静脉综合征），或存在发生食管气管瘘或食管胸膜瘘风险； 11. 既往抗肿瘤治疗的毒性尚未恢复至<=1 级（基于 NCI CTCAE v5.0 评估）或入排标准规定的水平（脱发、乏力等研究者判断低安全风险的毒性除外）。 12. 患有在过去两年内需要系统性治疗的活动性自身免疫性疾病（包括但不限于：自身免疫性肝炎、葡萄膜炎、肠炎、垂体炎、血管炎、肾炎、甲状腺功能亢进、甲状腺功能降低等），系统性治疗包括改善病情药物、免疫抑制剂、全身皮质类固醇给药（> 10 mg/天泼尼松或等效药物）等。激素替代治疗，如甲状腺素、胰岛素、或针对肾上腺或垂体功能不全的生理性皮质类固醇替代治疗不认为是一种系统性治疗；给药前 2 周内接受> 10 mg/天泼尼松的全身皮质类固醇治疗或其他免疫抑制药物的受试者。 13. 已知的活动性肺结核。怀疑有活动性肺结核的受试者，需进行临床检查排除； 14. 已知异体器官移植史和异体造血干细胞移植史； 15. 活动性乙型肝炎[乙肝表面抗原（HBsAg）阳性，须进行 HBV-DNA 检测；HBV-DNA>=500 IU/mL 或高于检测值下限，以较高者为准]或丙型肝炎（丙肝抗体阳性，且 HCV-RNA 高于检测值下限）。注：对于 HBsAg 阳性的受试者，要求在研究治疗期间接受抗乙肝病毒治疗； 16. 人类免疫缺陷病毒（HIV）检查阳性或存在获得性免疫缺陷综合征（艾滋病）病史；已知活动性梅毒感染； 17. 已知对研究药物或其任何成分过敏，已知对其他生物制剂产生严重超敏反应的病史； 18. 给药前 4 周内进行过大型手术者或预计在研究期间需要进行大手术者； 19. 给药前 4 周内发生严重感染，包括但不限于伴有需要住院治疗的并发症、败血症或严重肺炎；给药前 2 周内存在需要接受全身系统性抗感染治疗的活动性感染； 20. 给药前 2 周内接受过非特异性免疫调节治疗（包括但不限于干扰素、IL-2）、获批抗肿瘤适应症的中成药制剂（详见附件 6）等； 21. 给药前 30 天内接种了活疫苗，或计划在研究期间接种活疫苗； 22. 给药前的筛选过程中，病情快速恶化，例如体能状态的明显变化等； 23. 妊娠期或者哺乳期妇女； 24. 患有非恶性肿瘤导致的局部或全身性疾病，或肿瘤继发的疾病或症状，并可导致较高医学风险和/或生存期评价的不确定性，如肿瘤类白血病反应、恶病质表现等； 25. 有记录的重度干眼综合征，重度睑板腺疾病和或睑缘炎，或存在妨碍延迟角膜愈合的角膜疾病病史； 26. 研究者认为干扰研究药物的评价或受试者安全性或研究结果解析的任何状况或其他研究者认为不宜参加本研究的状况。

Exclusion criteria：

1. Received any of the following treatments in the advanced stage: (1) Chemotherapy; (2) Any drug treatment containing targeted topoisomerase I inhibitors, including antibody-drug conjugate (ADC) therapy; (3) Immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, or any other treatment targeting tumor immune mechanisms; 2. Recurrence or metastasis occurring within 12 months after the last chemotherapy in the early stage; 3. Subjects with central nervous system (CNS) metastases. For subjects with brain metastases who have previously received local treatment, enrollment is permitted if they are clinically stable for at least 4 weeks prior to dosing and do not require glucocorticoids or anticonvulsants for at least 14 days; 4. History of other malignant tumors within 5 years prior to dosing (except for tumors cured by local treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.); 5. Presence of any of the following cardiovascular and cerebrovascular diseases or risk factors: (1) Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, Grade 3 or 4 heart failure [according to the New York Heart Association (NYHA) classification (see Appendix 5 for details)], symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other severe cardiovascular and cerebrovascular diseases within 6 months prior to dosing; (2) History of myocardial diseases such as myocarditis, primary cardiomyopathy, or specific cardiomyopathy; (3) Any deep vein thrombosis within 3 months prior to dosing (enrollment is permitted if stabilized for >=2 weeks with low molecular weight heparin or similar efficacy drugs), peripheral arterial thromboembolic events, pulmonary embolism, or other severe thromboembolic events; (4) Presence of life-threatening major vascular diseases such as aortic aneurysm or aortic dissection aneurysm, or those requiring surgery within 6 months prior to dosing; 6. Uncontrolled systemic diseases as judged by the investigator: (1) Poorly controlled diabetes (fasting blood glucose >=10 mmol/L on two consecutive occasions); (2) Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg); (3) Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage (>1 time/week); 7. History of interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, current ILD or non-infectious pneumonia, or suspected ILD or non-infectious pneumonia that cannot be excluded by imaging during screening; 8. Clinically severe lung impairment caused by concurrent pulmonary diseases, including but not limited to any underlying lung disease (such as pulmonary embolism within 3 months prior to dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases that may involve the lungs (i.e., rheumatoid arthritis, Sj?gren's syndrome, sarcoidosis, etc.), or history of total pneumonectomy; 9. Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess, or acute gastrointestinal bleeding; 10. Tumor invasion or compression of surrounding vital organs and blood vessels (such as the heart, esophagus, superior vena cava, etc.) accompanied by related symptoms (such as superior vena cava syndrome), or risk of developing esophageal-tracheal fistula or esophageal-pleural fistula; 11. Toxicity from previous anti-tumor treatment has not recovered to <= Grade 1 (based on NCI CTCAE v5.0 assessment) or the level specified in the inclusion/exclusion criteria (except for toxicities judged by the investigator to be of low safety risk, such as alopecia and fatigue). 12. Active autoimmune diseases requiring systemic treatment within the past two years (including but not limited to: autoimmune hepatitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, etc.). Systemic treatment includes disease-modifying drugs, immunosuppressants, and systemic corticosteroid administration (>10 mg/day prednisone or equivalent). Hormone replacement therapy, such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, is not considered systemic treatment; subjects who received systemic corticosteroid treatment with >10 mg/day prednisone or other immunosuppressive drugs within 2 weeks prior to dosing. 13. Known active tuberculosis. Subjects suspected of having active tuberculosis must undergo clinical examination to exclude it; 14. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 15. Active hepatitis B [Hepatitis B surface antigen (HBsAg) positive, HBV-DNA testing required; HBV-DNA >=500 IU/mL or above the lower limit of detection, whichever is higher] or hepatitis C (hepatitis C antibody positive, and HCV-RNA above the lower limit of detection). Note: HBsAg-positive subjects are required to receive anti-hepatitis B virus treatment during the study treatment period; 16. Positive test for Human Immunodeficiency Virus (HIV) or history of Acquired Immunodeficiency Syndrome (AIDS); known active syphilis infection; 17. Known allergy to the study drug or any of its components, or history of severe hypersensitivity reactions to other biologics; 18. Underwent major surgery within 4 weeks prior to dosing or expected to require major surgery during the study period; 19. Severe infection occurred within 4 weeks prior to dosing, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective treatment within 2 weeks prior to dosing; 20. Received non-specific immunomodulatory therapy (including but not limited to interferon, IL-2) or approved Chinese patent medicine preparations for anti-tumor indications (see Appendix 6 for details) within 2 weeks prior to dosing; 21. Received live vaccines within 30 days prior to dosing, or planned to receive live vaccines during the study period; 22. Rapid deterioration of condition during the screening process prior to dosing, such as significant changes in performance status, etc.; 23. Pregnant or lactating women; 24. Local or systemic diseases not caused by malignant tumors, or diseases or symptoms secondary to tumors, which may lead to higher medical risks and/or uncertainty in survival evaluation, such as leukemoid reaction, cachexia, etc.; 25. Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal diseases that hinder delayed corneal healing; 26. Any condition that the investigator believes may interfere with the evaluation of the study drug, subject safety, or interpretation of study results, or any other condition deemed unsuitable for participation in this study by the investigator.

研究实施时间：

Study execute time：

从 From 2025-08-01 00:00:00至 To 2028-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-11-12 00:00:00 至 To 2028-12-30 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

35

Group：

Trial group

Sample size：

干预措施：

芦康沙妥珠单抗（5mg/kg, Q2W）联合塔戈利单抗（900 mg, Q2W)，静脉输注

干预措施代码：

Intervention：

Lukangsatuzumab (5 mg/kg, Q2W) combined with Tagolimab (900 mg, Q2W), intravenous infusion

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

中山大学肿瘤防治中心(中山大学附属肿瘤医院、中山大学肿瘤研究所) 

单位级别：

三甲 

Institution
hospital：

Sun Yat-sen University Cancer Center (Sun Yat-sen University Tumor Hospital, Sun Yat-sen University Institute of Oncology)

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

中山大学附属第五医院 

单位级别：

三甲 

Institution
hospital：

The Fifth Affiliated Hospital, Sun Yat-sen University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

梅州市人民医院 

单位级别：

三甲 

Institution
hospital：

Meizhou People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

6 个月无进展生存期（PFS）率

指标类型：

主要指标

Outcome：

Progression-Free Survival Rate at 6 Months

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

Type：

Secondary 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（ORR）

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：

疾病控制率（DCR）

指标类型：

次要指标

Outcome：

Disease Control 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：

缓解持续时间（DoR）

指标类型：

次要指标

Outcome：

Duration of Response

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

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

所有不良事件（AE）、治疗期不良事件（TEAE）、严重不良事件（SAE）的发生率、严重程度及与研究药物的相关性

指标类型：

副作用指标

Outcome：

Incidence, Severity, and Relationship to Study Drug of All Adverse Events (AE), Treatment-Emergent Adverse Events (TEAE), and Serious Adverse Events (SAE)

Type：

Adverse events

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：

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）：

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

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）：

研究结束后半年；国家生物信息中心(https://www.cncb.ac.cn/)

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

Six months after the completion of the research; China National Center for Bioinformation (https://www.cncb.ac.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：

数据由实验研究助理按要求采集，并在时限要求内录入EDC系统

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

The data was collected by the experimental research assistant as required and entered into the EDC system within the specified time frame

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-02 15:22:59