中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600126829
最近更新日期： Date of Last Refreshed on：	2026-06-16 23:22:47
注册时间： Date of Registration：	2026-06-16 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	放疗联合芦康沙妥珠单抗治疗局部晚期、EGFR突变阳性、不可切除非小细胞肺癌的单臂、单中心、II期临床研究
Public title：	A Single-Arm, Single-Center, Phase II Clinical Study of Radiotherapy Combined with Sacituzumab Tirumotecan in the Treatment of Locally Advanced, EGFR Mutation-Positive, Unresectable Non-Small Cell Lung Cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	放疗联合芦康沙妥珠单抗治疗局部晚期、EGFR突变阳性、不可切除非小细胞肺癌的单臂、单中心、II期临床研究
Scientific title：	A Single-Arm, Single-Center, Phase II Clinical Study of Radiotherapy Combined with Sacituzumab Tirumotecan in the Treatment of Locally Advanced, EGFR Mutation-Positive, Unresectable Non-Small Cell Lung Cancer
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：	张子鹏	研究负责人：	滕菲菲
Applicant：	zipengzhang	Study leader：	Teng Feifei
申请注册联系人电话： Applicant telephone：	+86 13979192451	研究负责人电话： Study leader's telephone：	+86 531 67627082
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：	zipengzhang2022@163.com	研究负责人电子邮件： Study leader's E-mail：	tengfeifei16@126.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：	济南市槐荫区济兖路440号	研究负责人通讯地址：	山东省济南市槐荫区济兖路440号
Applicant address：	No. 440, Jiyan Road, Huaiyin District, Jinan City	Study leader's address：	No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong 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：	山东省肿瘤医院
Applicant's institution：	Shandong Province Cancer Hospital
研究负责人所在单位：	山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）
Affiliation of the Leader：	Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute)

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：	SDZLEC 2026-034-002	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：	山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）伦理委员会
Name of the ethic committee：	Ethics Committee of the Affiliated Cancer Hospital of Shandong First Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2026-05-15 00:00:00
伦理委员会联系人：	李朝伟
Contact Name of the ethic committee：	Li ChaoWei
伦理委员会联系地址：	山东省济南市槐荫区济兖路440号
Contact Address of the ethic committee：	No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 531 6762 7162	伦理委员会联系人邮箱： Contact email of the ethic committee：	sdzlllh803@126.com

研究实施负责（组长）单位：

山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）

Primary sponsor：

Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute)

研究实施负责（组长）单位地址：

山东省济南市槐荫区济兖路440号

Primary sponsor's address：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong 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)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）	具体地址：	山东省济南市槐荫区济兖路440号
Institution hospital：	Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute)	Address：	No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Sichuan Kelun-Botai Biopharmaceutical Co., Ltd.

研究疾病：

非小细胞肺癌

Target disease：

Non-small cell lung cancer

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：

II期临床试验

Study phase：

2

研究设计：

单臂

Study design：

Single arm

研究目的：

本研究的主要目的为评估放疗联合芦康沙妥珠单抗治疗局部晚期、EGFR突变阳性、不可切除NSCLC的安全性；次要目的为评估其临床疗效；探索性目的为评估靶向Trop2核医学PET/CT分子探针（68Ga-Trop2 PET/CT）在该治疗前后评估中的临床可行性。

Objectives of Study：

The primary objective of this study is to evaluate the safety of radiotherapy combined with Sacituzumab Tirumotecan in the treatment of locally advanced, EGFR mutation-positive, unresectable NSCLC; the secondary objective is to assess its clinical efficacy; the exploratory objective is to evaluate the clinical feasibility of the targeted Trop2 nuclear medicine PET/CT molecular probe (68Ga-Trop2 PET/CT) in assessments before and after this treatment.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Voluntarily sign a written informed consent form;
2. Male or female aged 18–75 at the time of signing the consent;
3. ECOG performance status score of 0 or 1;
4. Expected survival of at least 3 months;
5. Pathologically or cytologically confirmed locally advanced, unresectable stage III non-small cell lung cancer, as determined by the investigator;
6. Pathologically or cytologically confirmed EGFR-sensitive mutation positive (19del/L858R);
7. Subjects who have not received any form of prior systemic anti-tumor treatment;
8. At least one measurable lesion according to RECIST v1.1 (tumor lesion on CT scan >= 10 mm in longest diameter, lymph node lesion on CT scan >= 15 mm in short axis), suitable for repeated accurate measurement;
9. Major organ function sufficient to tolerate the treatment regimen;
10. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose (if the urine test is inconclusive, a serum test must be conducted, and the serum result prevails);
11. Female subjects of childbearing potential with male partners who are not sterilized must use highly effective contraception from the start of screening and agree to continue this for 120 days after the last study drug dose; periodic abstinence, safe period contraception, and withdrawal are not acceptable;
12. Male subjects who are not sterilized and have female partners of childbearing potential must use effective contraception from the start of screening until 120 days after the last dose; whether to stop contraception after this period should be discussed with the investigator.

排除标准：

肿瘤相关特征及治疗： 1. 大细胞癌及混合细胞肺癌，混有小细胞肺癌成份的患者； 2. 针对 NSCLC 进行过任何全身性或局部抗肿瘤治疗，包括细胞毒性药物治疗、免疫药物治疗、放疗、试验性治疗、生物制剂、小分子靶向治疗等； 3. 同时入组另一项临床研究，除非其为一项非干预性的临床研究或干预性研究的随访期（定义为首次用药时间距离前一项临床研究末次用药时间达4周以上或该研究药物的5个半衰期以上，以较短者为准）； 4. 首次给药前2周内针对非靶病灶进行了姑息性局部治疗；首次给药前2周内接受过非特异性免疫调节治疗（如白介素、干扰素、胸腺肽、肿瘤坏死因子等，不包括用于治疗血小板减少的IL-11）；首次给药前1周内曾接受具有抗肿瘤适应症的中草药或中成药； 5. 既往有酒精过敏史者； 6. 对PET/CT检查有顾虑者； 7. 有记录的重度干眼综合征，重度睑板腺疾病和睑缘炎，或存在妨碍延迟角膜愈合的角膜疾病病史； 8. 既往胸部放疗史； 9. 既往接受过化疗或任何EGFR酪氨酸激酶抑制剂（EGFR-TKI）治疗者（包括一代/二代/三代EGFR-TKI）。既往病史及合并疾病： 10. 首次用药前3年内患有除NSCLC以外的其他恶性肿瘤；允许纳入患有其他恶性肿瘤通过局部治疗已治愈的受试者，例如基底或皮肤鳞状细胞癌、浅表膀胱癌、宫颈或乳腺原位癌； 11. 首次用药前2年内患有需要系统性治疗的活动性自身免疫性疾病（如使用改善病情药物、皮质类固醇、免疫抑制剂治疗）（不包括使用PD-1/L1抑制剂导致的irAE）。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； 12. 筛选期影像提示活动性肺炎且未控制； 13. 首次用药前1年内存在重大疾病病史，具体为： (1) 首次给药前12个月内存在需住院治疗的不稳定性心绞痛、心肌梗塞、充血性心力衰竭（纽约心脏病协会NYHA分类>=2级）或血管疾病（如存在破裂风险的主动脉瘤），或可能影响研究药物安全性评价的其他心脏损害（如控制不佳的心律失常，心肌缺血等）； (2) 首次给药前6个月内存在食管胃底静脉曲张，严重溃疡，伤口未愈，腹瘘，腹腔内脓肿或急性胃肠道出血病史； (3) 首次给药前6个月内发生过任何动脉血栓栓塞事件，NCI CTCAE 5.0规定的3级及以上的静脉血栓栓塞事件，短暂性脑缺血发作，脑血管意外，高血压危象或高血压脑病； (4) 首次给药前4周内发生慢性阻塞性肺病急性加重； 14. 首次给药前6个月内有胃肠道穿孔和/或瘘管病史，胃肠梗阻病史（包括需要肠外营养的不完全肠梗阻），广泛肠切除（部分结肠切除或广泛小肠切除，并发慢性腹泻）； 15. 在首次给药前4周内接种了活疫苗或减毒活疫苗，或计划在研究期间接种活疫苗或减毒活疫苗，允许使用灭活疫苗； 16. 首次给药前4周内发生严重感染，包括但不局限于伴有需要住院治疗的合并症、败血症或严重肺炎；在首次给药前2周内接受过全身抗感染治疗的活动性感染（不包括乙型肝炎或丙型肝炎的抗病毒治疗）； 17. 在首次给药前4周内进行过重大外科手术或发生严重外伤，或在首次给药后的4周内有重大外科手术计划者（由研究者决定）；在首次给药前3天内进行过较小的局部手术（不包括经外周静脉穿刺中心静脉置管术和静脉输液港植入术）； 18. 有严重出血倾向或凝血功能障碍病史；首次给药前4周内存在具有显著临床意义的出血症状，包括但不限于消化道出血、咳血（定义为咳出或咯出>=1茶匙鲜血或小血块或只咳血无痰液，允许痰中带血者入组）、鼻腔出血（不包括鼻衄出血及回缩性涕血）；首次用药前10天内接受过持续的抗血小板或抗凝治疗； 19. 当前存在高血压且经口服降压药物治疗后收缩压>=150 mmHg或舒张压>=100 mmHg； 20. 经治疗未能控制的高血糖（空腹血糖>10 mmol/L）； 21. 既往存在需要系统性糖皮质激素治疗的非感染性肺炎病史或当前存在间质性肺疾病； 22. 活动性或既往有明确的炎症性肠病（如克罗恩病、溃疡性结肠炎或慢性腹泻）病史； 23. 存在免疫缺陷病史；HIV抗体检测阳性者；当前正在长期使用系统性皮质类固醇激素或其他免疫抑制剂； 24. 已知异体器官移植史和异体造血干细胞移植史； 25. 未经治疗的活动性乙型肝炎受试者（HBsAg阳性且HBV-DNA超过1000拷贝/mL（200 IU/mL）或高于检测下限，以高者为准），对于患有乙型肝炎的受试者，要求在研究治疗期间接受抗乙肝病毒治疗；活动性的丙型肝炎受试者（HCV抗体阳性且HCV-RNA水平高于检测下限）； 26. 已知存在活动性肺结核（TB）：怀疑有活动性TB的受试者，需进行临床检查排除； 27. 已知的活动性梅毒感染； 28. 已知对任何研究药物的任何成分过敏；已知对其他单克隆抗体产生严重超敏反应的病史； 29. 已知有精神疾病、药物滥用、酗酒或吸毒史； 30. 既往或当前存在任何疾病、治疗、实验室检查异常，可能会混淆研究结果，影响受试者全程参与研究，或参与研究可能不符合受试者的最佳利益； 31. 不受控制的代谢紊乱，或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（白细胞计数>20×10^9/L）、恶液质表现（如已知的筛选前3个月体重减轻超过10%）等。其他情况： 32. 处于妊娠期或哺乳期，或计划在研究期间哺乳； 33. 其他研究者认为不适合入组的情况。

Exclusion criteria：

Tumor-related features and treatment: 1. Patients with large cell carcinoma and mixed cell lung cancer, with small cell lung cancer components; 2. Have undergone any systemic or topical anti-tumor therapy for NSCLC, including cytotoxic drug therapy, immunotherapy, radiotherapy, investigational therapy, biologics, small molecule targeted therapy, etc.; 3. Simultaneous enrollment in another clinical study, unless it is a non-interventional clinical study or a follow-up period of an interventional study (defined as the first dose being at least 4 weeks after the last dose of the previous clinical study, or more than 5 half-lives of the study drug, whichever is shorter); 4. Palliative local treatment for non-targeted lesions within 2 weeks prior to the first dose; Non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc.) within 2 weeks prior to the first dose, excluding IL-11 used to treat thrombocytopenia; Received Chinese herbal medicine or proprietary Chinese medicines with antitumor indications within one week prior to the first dose; 5. History of alcohol allergy; 6. Those who have concerns about PET/CT scans; 7. Documented severe dry eye syndrome, severe meibomian gland disease, blepharitis, or a history of corneal diseases that hinder delayed corneal healing; 8. History of chest radiotherapy; 9. Individuals who have previously received chemotherapy or any EGFR tyrosine kinase inhibitor (EGFR-TKI) treatment (including first-generation, second-generation, and third-generation EGFR-TKIs). Medical history and concomitants: 10. Malignant tumors other than NSCLC within the first 3 years prior to the first dose; Allow the inclusion of subjects with other malignancies who have been cured by local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or carcinoma in situ of the breast; 11. Having active autoimmune diseases requiring systemic treatment within 2 years prior to the first dose (such as symptom-improving drugs, corticosteroids, immunosuppressants) (excluding irAEs caused by PD-1/L1 inhibitors). Replacement therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic therapy; 12. Screening imaging indicates active pneumonia that is not controlled; 13. History of major illness within one year prior to first use, specifically: (1) Unstable angina, myocardial infarction, congestive heart failure (NYHA classification >=2) or vascular disease (such as aortic aneurysm at risk of rupture) or other cardiac damage that may affect the safety evaluation of the study drug within 12 months prior to the first dose (such as poorly controlled arrhythmias, myocardial ischemia, etc.); (2) History of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistula, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose; (3) Any arterial thromboembolic event within 6 months prior to first administration, venous thromboembolic event of grade 3 or above as defined by NCI CTCAE 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy; (4) Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to the first dose; 14. History of gastrointestinal perforation and/or fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea); 15. Live vaccine or attenuated live vaccine administered within 4 weeks prior to the first dose, or planned to receive live or attenuated live vaccine during the study period, using inactivated vaccines is permitted; 16. Severe infection within 4 weeks prior to first administration, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active infection with systemic anti-infective treatment within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or C); 17. Major surgical operation or severe trauma within 4 weeks prior to the first dose, or major surgical plans within 4 weeks after the first dose (determined by the investigator); Minor local surgery performed within 3 days prior to the first dose (excluding peripheral venous puncture central vein catheterization and intravenous port implantation); 18. History of severe bleeding tendencies or coagulation disorders; Clinically significant bleeding symptoms within 4 weeks before the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or coughing up blood> = 1 teaspoon of fresh blood or small blood clots, or coughing up blood only without sputum; those with blood in the sputum are allowed to be included), nasal bleeding (excluding epistaxis and retractable nasal bleeding); Continuous antiplatelet or anticoagulant therapy within 10 days prior to the first dose; 19. Current hypertension with systolic blood pressure >=150 mmHg or diastolic pressure >=100 mmHg after oral antihypertensive drug treatment; 20. Uncontrolled hyperglycemia after treatment (fasting blood glucose >10 mmol/L); 21. History of non-infectious pneumonia requiring systemic glucocorticoid therapy or current interstitial lung disease; 22. Active or clear history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea); 23. History of immunodeficiency; Those who test positive for HIV antibodies; Currently using systemic corticosteroids or other immunosuppressants long-term; 24. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 25. Untreated active hepatitis B subjects (HBsAg positive with HBV-DNA exceeding 1000 copies/mL (200 IU/mL) or above the lower detection limit, whichever is higher), require anti-hepatitis B virus therapy during the study period for hepatitis B subjects; Active hepatitis C subjects (HCV antibody positive with HCV-RNA levels above the detection threshold); 26. Known active pulmonary tuberculosis (TB): Subjects suspected of active TB require clinical examination to exclude; 27. Known active syphilitic infection; 28. Known allergy to any component of any investigational drug; Known history of severe hypersensitivity to other monoclonal antibodies; 29. Known history of mental illness, substance abuse, alcoholism, or drug use; 30. Any past or current diseases, treatments, or laboratory abnormalities that may confuse research results, affect subjects' participation throughout the study, or may not be in the best interests of the subject; 31. Uncontrolled metabolic disorders, or local or systemic diseases caused by non-malignant tumors, or tumor-secondary diseases or symptoms, which can lead to higher medical risks and/or uncertainty in survival assessment, such as tumor leukemia response (leukocyte count> 20×10^9/L), cachexia manifestations (known weight loss of more than 10% in the first 3 months prior to screening), etc. Other Situations: 32. Pregnant or breastfeeding, or planning to breastfeed during the study; 33. Other situations deemed unsuitable by the investigator for enrollment.

研究实施时间：

Study execute time：

从 From 2026-06-09 00:00:00至 To 2029-06-06 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-06-16 00:00:00 至 To 2029-06-06 00:00:00

干预措施：

Interventions：

组别：	安全性导入阶段	样本量：	6
Group：	Safety run-in	Sample size：	6
干预措施：	芦康沙妥珠单抗联合根治性放疗，后续第三代EGFR-TKI维持治疗	干预措施代码：
Intervention：	Sacituzumab tirumotecan combined with definitive radiotherapy, followed by maintenance third-generation EGFR-TKI	Intervention code：

组别：	扩展阶段	样本量：	33
Group：	Expansion cohort	Sample size：	33
干预措施：	芦康沙妥珠单抗联合根治性放疗，后续第三代EGFR-TKI维持治疗	干预措施代码：
Intervention：	Sacituzumab tirumotecan combined with definitive radiotherapy, followed by maintenance third-generation EGFR-TKI	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）	单位级别：	三级甲等
Institution hospital：	Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute)	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	DLT发生率	指标类型：	主要指标
Outcome：	Dose-limiting toxicity (DLT) rate	Type：	Primary indicator
测量时间点：	自首次给药至根治性放疗结束后90天（±7天）	测量方法：	按方案定义统计发生DLT的受试者比例，采用例数、百分比及95%置信区间描述
Measure time point of outcome：	From first dose to 90 days (±7 days) after completion of definitive radiotherapy	Measure method：	Proportion of patients with DLTs, summarized by counts, percentages, and 95% CI

指标中文名：	Grade ≥3 TRAE发生率	指标类型：	主要指标
Outcome：	Incidence of treatment-related grade ?= 3 adverse events	Type：	Primary indicator
测量时间点：	同步治疗期间及放疗结束后90天内	测量方法：	按NCI CTCAE v5.0分级，统计Grade ≥3 TRAE发生率，以例数和百分比描述
Measure time point of outcome：	During concurrent therapy and within 90 days after radiotherapy completion	Measure method：	Incidence of treatment-related Grade >= 3 AEs graded by NCI CTCAE v5.0, summarized by counts and percentages

指标中文名：	总体生存期（OS）	指标类型：	次要指标
Outcome：	Overall survival (OS)	Type：	Secondary indicator
测量时间点：	自首次给药至任何原因死亡；末次给药后每3个月随访	测量方法：	采用Kaplan–Meier法估计中位OS及95%置信区间
Measure time point of outcome：	From first dose to death from any cause; followed every 3 months after last dose	Measure method：	Median OS and 95% CI estimated by the Kaplan–Meier method

指标中文名：	至首次后续治疗时间（TFST）	指标类型：	次要指标
Outcome：	Time to first subsequent therapy (TFST)	Type：	Secondary indicator
测量时间点：	自首次给药至首次开始任何后续全身抗肿瘤治疗或死亡	测量方法：	采用Kaplan–Meier法估计中位TFST及95%置信区间
Measure time point of outcome：	From first dose to initiation of first subsequent systemic anti-cancer therapy or death	Measure method：	Median TFST and 95% CI estimated by the Kaplan–Meier 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 (PFS)	Type：	Secondary indicator
测量时间点：	自首次给药至RECIST v1.1定义的疾病进展或死亡	测量方法：	采用Kaplan–Meier法估计中位PFS及95%置信区间
Measure time point of outcome：	From first dose to RECIST-defined progression or death	Measure method：	Median PFS and 95% CI estimated by the Kaplan–Meier method

指标中文名：	PET/CT定量参数（SUVmax、TBR、ΔSUVmax）	指标类型：	次要指标
Outcome：	PET/CT quantitative parameters (SUVmax, TBR, ΔSUVmax)	Type：	Secondary indicator
测量时间点：	治疗前及治疗后规定时间点	测量方法：	采用描述性统计，并探索其与ORR、PFS、TFST等结局的相关性
Measure time point of outcome：	Pre-treatment and protocol-defined post-treatment timepoints	Measure method：	Descriptive statistics and exploratory correlation analyses with ORR, PFS, and TFST

指标中文名：	客观缓解率（ORR）	指标类型：	主要指标
Outcome：	Objective response rate (ORR)	Type：	Primary indicator
测量时间点：	基线后按方案规定影像学评估时间点，至疾病进展或研究治疗结束	测量方法：	按RECIST v1.1评估CR+PR，采用Clopper–Pearson法计算95%置信区间
Measure time point of outcome：	At protocol-defined post-baseline imaging assessments until disease progression or end of treatment	Measure method：	CR + PR assessed by RECIST v1.1; 95% CI calculated using the Clopper–Pearson method

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	基线外周血血清样本	组织：
Sample Name：	Baseline peripheral blood serum sample	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：	治疗过程及进展时外周血样本	组织：
Sample Name：	Peripheral blood samples during treatment and at progression/recurrence	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：	基线肿瘤组织样本	组织：
Sample Name：	Baseline tumor tissue sample	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：	基线外周血血浆样本（ctDNA）	组织：
Sample Name：	Baseline peripheral blood plasma sample (ctDNA)	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	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	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）：	不适用
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Not Applicable
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：	病例报告表
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：	有/Yes
注册人： Name of Registration：	2026-06-16 23:21:57