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：	ChiCTR2500095540
最近更新日期： Date of Last Refreshed on：	2025-01-08 15:14:54
注册时间： Date of Registration：	2025-01-08 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	化免诱导治疗后同步/序贯放化疗及免疫巩固治疗Ⅲ期不可切非小细胞肺癌的单臂、多中心、探索性临床研究
Public title：	A single-arm, multicenter, exploratory clinical study of concurrent/sequential chemoradiotherapy and immunoconsolidation therapy for stage III non-resectable non-small cell lung cancer after chemoimmunotherapy induction therapy
注册题目简写：
English Acronym：
研究课题的正式科学名称：	化免诱导治疗后同步/序贯放化疗及免疫巩固治疗Ⅲ期不可切非小细胞肺癌的单臂、多中心、探索性临床研究
Scientific title：	A single-arm, multicenter, exploratory clinical study of concurrent/sequential chemoradiotherapy and immunoconsolidation therapy for stage III non-resectable non-small cell lung cancer after chemoimmunotherapy induction therapy
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：	孙彦莉	研究负责人：	徐双兵
Applicant：	Sun Yanli	Study leader：	Xu Shuangbing
申请注册联系人电话： Applicant telephone：	+86 186 7837 9949	研究负责人电话： Study leader's telephone：	+86 159 2726 5462
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：	18678379949@163.com	研究负责人电子邮件： Study leader's E-mail：	xsb723@hust.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：	山东省济南市历下区祥恒广场1702	研究负责人通讯地址：	湖北省武汉市解放大道1277号华中科技大学同济医学院附属协和医院
Applicant address：	1702, Xiangheng Plaza, Lixia District, Jinan City, Shandong Province	Study leader's address：	Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, No. 1277 Jiefang Avenue, Wuhan City, Hubei 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：	江苏恒瑞医药股份有限公司
Applicant's institution：	Jiangsu Hengrui Pharmaceutical Co., Ltd
研究负责人所在单位：	华中科技大学同济医学院附属协和医院
Affiliation of the Leader：	Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

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：	[2024]伦审字(0157-02)号	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：	华中科技大学同济医学院附属协和医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
伦理委员会批准日期： Date of approved by ethic committee：	2024-04-30 00:00:00
伦理委员会联系人：	华中科技大学同济医学院附属协和医院医学伦理委员会
Contact Name of the ethic committee：	Medical Ethics Committee of Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
伦理委员会联系地址：	湖北省武汉市解放大道 1277 号
Contact Address of the ethic committee：	Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, No. 1277 Jiefang Avenue, Wuhan City, Hubei Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 27 8572 6375	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：

华中科技大学同济医学院附属协和医院

Primary sponsor：

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

研究实施负责（组长）单位地址：

湖北省武汉市解放大道1277号

Primary sponsor's address：

No. 1277 Jiefang Avenue, Wuhan City, Hubei 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)：	湖北	市(区县)：	武汉
Country：	China	Province：	Hubei	City：	Wuhan
单位(医院)：	华中科技大学同济医学院附属协和医院	具体地址：	湖北省武汉市解放大道1277号
Institution hospital：	Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology	Address：	No. 1277 Jiefang Avenue, Wuhan City, Hubei Province

经费或物资来源：

自筹

Source(s) of funding：

Self-found

研究疾病：

非小细胞肺癌

Target disease：

Non-small cell lung cancer, NSCLC

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：评价化免诱导治疗后同步/序贯放化疗及免疫巩固治疗Ⅲ期不可切非小细胞肺癌的1年PFS率；次要研究目的：疗效：评价化免诱导治疗后同步/序贯放化疗及免疫巩固治疗Ⅲ期不可切非小细胞肺癌的无进展生存期（progression-free survival,无进展生存期）；客观缓解率（overall response rate,ORR）、缓解持续时间（duration of response,DoR）、疾病控制率（disease control rate,DCR）及、总生存期（overall survival,OS）；安全性：评价化免诱导治疗后同步/序贯放化疗及免疫巩固治疗Ⅲ期不可切非小细胞肺癌的安全性；探索性研究目的：探索肿瘤生物学标志物（包括但不限于PD-L1表达状态、淋巴细胞因子、淋巴细胞亚群等）与疗效的关联性；

Objectives of Study：

Main Objectives: To evaluate the 1-year PFS rate of stage III non-recutable non-small cell lung cancer after chemoimmunoinduction-free therapy followed by concurrent/sequential chemoradiotherapy and immunoconsolidation therapy; Secondary objectives: Efficacy: To evaluate the progression-free survival (progression-free survival) of stage III. non-recutable non-small cell lung cancer after chemo-immunoinduction therapy; overall response rate (ORR), duration of response (DoR), disease control rate (DCR), and overall survival (OS); Security: To evaluate the safety of concurrent/sequential chemoradiotherapy and immunoconsolidation therapy for stage III non-refractive non-small cell lung cancer after chemo-induction-free therapy; Objectives of the exploratory study: To explore the association between tumor biomarkers (including but not limited to PD-L1 expression status, lymphocytokines, lymphocyte subsets, etc.) and 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.年龄18-75周岁（含两端值），男女均可；
2.组织学或细胞学证实的IIIB-IIIC期NSCLC；
3.ECOG体能状况评分0~1分；
4.既往未接受过针对III期NSCLC的系统治疗或者免疫检查点抑制剂的治疗；
5.EGFR/ALK/ROS1阴性；
6.育龄妇女必须在首次用药前7天内进行血清妊娠研究，且结果为阴性。育龄妇女受试者和伴侣为育龄妇女的男性受试者必须同意自签署知情同意书至末次给予研究药物后24周内避孕（推荐的避孕方法参照方案4.3.1）；
7.预期生存时间≥12周；
8.按照RECIST1.1标准，受试者必须至少有一个通过CT或MRI检查的可测量病灶；
9.首剂研究药物前，实验室检查值满足以下条件：
（1）血常规（筛查前14天内未输血、未使用造血刺激因子类药物纠正）：白细胞计数（whitebloodcell,WBC）≥3.0×109/L；绝对中性粒细胞计数（absoluteneutrophilcount,ANC）≥1.5×109/L；血小板（platelet,PLT）≥100×109/L；血红蛋白含量（hemoglobin,HGB）≥9.0g/dL；
（2）肝功能：无肝转移受试者天门冬氨酸氨基转移酶（aspartatetransferase,AST）≤2.5xULN；丙氨酸肝氨基转移酶（alanineaminotransferase,ALT）≤2.5xULN，肝转移受试者其ALT、AST≤5xULN；血清总胆红素（totalbilirubin,TBIL）≤1.5xULN(除外Gilbert综合征总胆红素≤3.0mg/dL)；
（3）肾功能：血清肌酐≤1.5xULN或肌酐清除率(creatinineclearancerate,CrCl)≥50mL/minute(使用Cockcroft/Gault公式，参照附件二)；
（4）凝血功能：国际标准化比率（internationalnormalizedratio,INR）≤1.5xULN，活化部分凝血活酶时间（activatedpartialthromboplastintime,APTT）≤1.5xULN（仅适用于目前没有接受抗凝治疗的患者，对于目前正在接受抗凝治疗的患者应接受稳定剂量的抗凝剂治疗）；
（5）其他：脂肪酶≤1.5xULN（若脂肪酶>1.5xULN无临床或影像学证实胰腺炎的情况可以入组）；淀粉酶≤1.5xULN（若淀粉酶>1.5xULN无临床或影像学证实胰腺炎的情况可以入组）；碱性磷酸酶（alkalinephosphatase,ALP）≤2.5ULN，肝转移或骨转移受试者，ALP≤5ULN；
10.受试者自愿加入本研究，签署知情同意书，依从性好，配合随访。

Inclusion criteria

1. Age 18-75 years old (both ends), male and female;
2. Histologically or cytologically confirmed stage IIIB-IIIC NSCLC;
3. ECOG physical fitness status score 0~1 points;
4. No prior systemic therapy for stage III NSCLC or treatment with immune checkpoint inhibitors;
5. Negative for EGFR/ALK/ROS1;
6. Women of childbearing potential must have a serum pregnancy study within 7 days before the first dose and the result is negative. Female subjects of childbearing potential and male subjects whose partner is a woman of childbearing potential must agree to contraception for 24 weeks from the time of signing the informed consent form to the last dose of study drug (the recommended contraceptive method refers to protocol 4.3.1);
7. Expected survival time>=12 weeks;
8. Subjects must have at least one measurable lesion by CT or MRI examination in accordance with RECIST1.1 criteria;
9. Before the first dose of study drug, the laboratory test value meets the following conditions:
(1) Blood routine (no blood transfusion within 14 days before screening, no correction with hematopoietic stimulating factor drugs): white blood cell count (WBC) >= 3.0×109/L; absolute neutrophil count (ANC) >= 1.5×109/L; platelet (PLT) >=100×109/L; hemoglobin (HGB) >= 9.0g/dL;
(2) Liver function: aspartate transferase (AST) <= 2.5xULN in subjects without liver metastases, alanineaminotransferase (ALT) <= 2.5xULN, and ALT and AST <=5xULN in subjects with liver metastases; serum total bilirubin (TBIL) <= 1.5xULN (excluding Gilbert's syndrome total bilirubin <=3.0 mg/dL);
(3) Renal function: serum creatinine <=1.5xULN or creatinine clearancerate (CrCl) >=50mL/minute (using the Cockcroft/Gault formula, refer to Annex II);
(4) Coagulation function: international normalized ratio (INR) <=1.5xULN, activated partialthromboplastintime (APTT) <=1.5xULN (only applicable to patients who are not currently receiving anticoagulant therapy, and patients who are currently receiving anticoagulant therapy should receive a stable dose of anticoagulant therapy);
(5) Others: lipase<=1.5xULN (if lipase >1.5xULN without clinical or imaging evidence of pancreatitis); Amylase <=1.5xULN (if amylase >1.5xULN without clinical or radiologic evidence of pancreatitis); alkalinephosphatase (ALP) <=2.5ULN, liver metastasis or bone metastasis,ALP <=5ULN;
10. The subjects voluntarily participated in this study, signed the informed consent form, with good compliance, and cooperated with follow-up.

排除标准：

1.筛选期和既往影像学评估，经计算机断层扫描（CT）或磁共振成像（MRI）检测发现活动性或症状未控制的CNS转移灶； 2.手术和／或放疗治疗未能缓解的脊髓压迫，或既往诊断的脊髓压迫经治疗后没有临床证据显示在参与本研究前疾病稳定≥１周； 3.软脑膜疾病； 4.EGFR/ALK/ROS1阳性 5.有临床症状的第三间隙积液需要反复引流，如经抽水或其他治疗仍无法控制的心包积液、胸腔积液和腹腔积液； 6.无法控制的或症状性高血钙症； 7.首剂用药前≤5年并发其他恶性肿瘤，充分治疗的宫颈原位癌、基底细胞或鳞状上皮细胞皮肤癌、根治术后的局部前列腺癌、根治术后的导管原位癌除外（允许非转移性前列腺癌或乳腺癌的激素治疗）； 8.活动性、已知或怀疑自身免疫性疾病（参照附件四）包括但不仅限于重症肌无力、自身免疫性肝炎、系统性红斑狼疮类风湿性关节炎、炎性肠病等。允许I型糖尿病（通过胰岛素治疗血糖得以控制）、仅需要激素替代疗法治疗的因自身免疫性甲状腺炎导致的残留甲状腺功能减退，或缺乏外因刺激的情况下预期不会复发的情况可以入组；患有湿疹、牛皮癣、慢性单纯性苔藓或仅有白癜风皮肤病表现的患者（需排除银屑病性关节炎）如果皮疹覆盖面积小于体表面积10%，基线时疾病已充分控制且仅需要低效价的局部类固醇治疗，过去12个月内基础疾病未出现急性加重（不需要补骨脂素加紫外线辐射[PUVA]、氨甲喋呤、类视黄醇、生物制剂、口服钙调磷酸酶抑制剂、高效价或口服类固醇）则可以进入研究； 9.既往接受过任何T细胞共刺激或免疫检查点治疗，包括但不限于细胞毒性T淋巴细胞相关抗原-4（cytotoxicTlymphocyte-associatedantigen-4，CTLA-4）抑制剂、PD-1抑制剂、PD-L1/2抑制剂或其他靶向T细胞的药物； 10.首剂研究药物前≤14天内使用皮质类固醇激素（＞10mg/天强的松或等效剂量）或其他免疫抑制剂进行系统治疗的受试者。没有活动性自身免疫疾病的情况下允许吸入或局部使用皮质类固醇，以及剂量＞10mg/天泼尼松疗效剂量的肾上腺激素替代疗法； 11.HBsAg阳性且HBVDNA拷贝数大于所在研究中心检验科正常值上限（1000拷贝数/ml或500IU/ml ），或HCV阳性（HCVRNA或HCVAb检测提示急慢性感染）；已知HIV阳性病史或已知的获得性免疫缺陷综合征（AcquiredImmuneDeficiencySyndrome,AIDS）； 12.患有特发性肺纤维化病史、机化性肺炎（如闭塞性细支气管炎）、药物诱导的肺炎、需要类固醇治疗的放射性肺炎或有临床症状的活动性肺炎；或其他严重影响肺功能的中重度肺部疾病（放射区存在放射性肺炎（纤维化）病史的患者可参加本研究）； 13.活动性肺结核（tuberculosis,TB）或筛选前≤48周内有活动性肺结核感染病史的受试者，无论是否治疗； 14.存在重度感染，包括但不仅限于需住院治疗的感染并发症、菌血症、重症肺炎等； 15.参与本研究前28天内接受过大型手术，或计划在研究期间接受大型手术； 16.参与本研究前28天内使用减毒活疫苗，或预计研究期间需要使用此种减毒活疫苗（参与研究前4周、治疗期间以及阿得贝利单抗末次给药后5个月内患者不允许接种流感减毒活疫苗）； 17.有严重的心血管疾病，如纽约心脏病协会（NewYorkHeartAssociation,NYHA）2级以上心力衰竭、不稳定型心绞痛、不稳定性心律失常、参与本研究前3个月内发生的心肌梗死或脑血管意外； 18.既往接受过同种异体骨髓移植或实体器官移植的患者； 19.已知对研究药物或辅料过敏，已知对任何一种单抗发生严重过敏反应；有卡铂或培美曲塞/白蛋白紫杉醇过敏史； 20.签署ICF前4周内曾接受其它任何研究药物治疗或参加过另一项干预性临床研究； 21.已知有精神疾病、酗酒、无法戒烟、吸毒或药物滥用等情况； 22.经研究者判断，受试者有其他可能导致本研究被迫中途终止的因素，如，不依从方案、其他的严重疾病（含精神疾病）需要合并治疗，有严重的实验室检查异常，伴有家庭或社会等因素，会影响到受试者的安全，或资料及样品的收集。

Exclusion criteria：

1. Active or symptomatic CNS metastases detected by computed tomography (CT) or magnetic resonance imaging (MRI) during screening and previous imaging assessments; 2. Spinal cord compression that was not relieved by surgery and/or radiotherapy, or previously diagnosed spinal cord compression that was treated without clinical evidence of stable disease for at least 1 week before study entry; 3. Leptomeningeal disease; 4.EGFR/ALK/ROS1 positivity 5. Clinically symptomatic third space effusion requiring repeated drainage, such as pericardial effusion, pleural effusion and peritoneal effusion that could not be controlled by pumping or other treatments; 6. Uncontrolled or symptomatic hypercalcemia; 7. Other malignant tumors occurred within 5 years before the first dose, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical prostatectomy, and ductal carcinoma in situ after radical prostatectomy (hormone therapy for non-metastatic prostate cancer or breast cancer was allowed); 8. Active, known or suspected autoimmune diseases (see Annex IV) include, but are not limited to, myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. Patients with type I diabetes (glycemic control with insulin therapy), residual hypothyroidism due to autoimmune thyroiditis requiring only hormone-replacement therapy, or no expected recurrence in the absence of external stimuli were allowed. Patients with eczema, psoriasis, lichen simplex, or only skin manifestations of vitiligo (excluding psoriatic arthritis) if the rash covers less than 10% of the body surface area, the disease is adequately controlled at baseline, and only low-potency topical steroids are required. Patients were eligible if they had not had an acute exacerbation of an underlying medical condition (no requirement for psoralen plus ultraviolet radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high-potency, or oral steroids) within the previous 12 months. 9. Any prior T cell costimulation or immune checkpoint therapy, including but not limited to cytotoxicTlymphocyte-associatedantigen-4 (cytotoxicTlymphocyte-associatedantigen-4), CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other drugs targeting T cells; 10. Subjects on systemic treatment with corticosteroids (> 10mg/ day prednisone or equivalent) or other immunosuppressive agents within 14 days before the first dose of study drug. Inhaled or topical corticosteroids and adrenal-hormone-replacement therapy at a efficacy dose of prednisone of more than 10mg per day were allowed in the absence of active autoimmune disease. 11.HBsAg positive and HBVDNA copy number greater than the upper limit of normal value (1000 copies /ml or 500IU/ml), or HCV positive (HCVRNA or HCVAb test indicates acute or chronic infection); The known history of HIV positive or known acquired immune deficiency syndrome (AcquiredImmuneDeficiencySyndrome, AIDS); 12. A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or clinically active pneumonia; Or other moderate to severe lung diseases that seriously affect lung function (patients with a history of radiation pneumonitis (fibrosis) in the radiation area can participate in this study); tuberculosis (TB) or a history of active TB infection within 48 weeks or less before screening, whether treated or not; 14. Presence of severe infection, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc. 15. Have undergone major surgery within 28 days before enrollment or are planning to undergo major surgery during the study; 16. Use of live attenuated influenza vaccine within 28 days before enrollment or anticipated need during the study (patients were not allowed to receive live attenuated influenza vaccine 4 weeks before enrollment, during treatment, or within 5 months after the last dose of adbelimumab); 17. Have serious cardiovascular disease, such as New York heart association (NewYorkHeartAssociation, NYHA) above grade 2 hf instability, unstable angina, arrhythmia, participate in this study the first 3 months of myocardial infarction, or cerebrovascular accident; 18. Patients with prior allogeneic bone marrow transplantation or solid organ transplantation; 19. Known allergy to the study drug or excipients, known severe allergic reaction to any of the mabs; History of allergy to carboplatin or pemetrexed/albumin paclitaxel; 20. Received any other study medication or participated in another interventional clinical study within 4 weeks before signing the ICF; 21. Known mental illness, alcohol abuse, inability to quit smoking, drug or substance abuse; 22. According to the investigator's judgment, the subjects have other factors that may lead to the forced termination of the study, such as non-compliance with the protocol, other serious diseases (including mental disorders) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which may affect the safety of the subjects, or the collection of data and samples.

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2027-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-01-15 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	37
Group：	Experimental group	Sample size：	37
干预措施：	诱导治疗：阿得贝利单抗1200mg,IV,Q3W+培美曲塞500mg/m2（非鳞癌）,D1/白蛋白紫杉醇260mg/m2（鳞癌）,D1+卡铂AUC5,D1；21天为一个治疗周期；3个周期。序贯/同步放化疗：诱导治疗结束后未进展（肿瘤缓解达到PR、CR或SD）的患者进入序贯/同步放化疗治疗，治疗方案为培美曲塞500mg/m2（非鳞癌）,D1/白蛋白紫杉醇260mg/m2（鳞癌）,D1+卡铂AUC5,D1/；最多2个周期，放疗剂量采用PTV 54-60Gy/27-30F（原发灶+淋巴结）。巩固治疗：放化疗治疗结束3周后进入巩固治疗阶段，根据临床医生和受试者自愿原则选择免疫标准巩固治疗，受试者接受巩固治疗，直至疾病进展、无法耐受的毒副作用、撤知情或研究者决定让受试者退出研究、不依从研究治疗或研究程序或方案规定的其他原因，最多14个周期。	干预措施代码：
Intervention：	Induction therapy: Adebelimab 1200 mg, IV, Q3W + pemetrexed 500 mg/m2 (non-squamous carcinoma), D1/nab-paclitaxel 260 mg/m2 (squamous cell carcinoma), D1 + carboplatin AUC5, D1; 21 days for a treatment cycle; 3 cycles. sequential/concurrent chemoradiotherapy: Patients who did not progress after the end of induction therapy (tumor remission reached PR, CR, or SD) were treated with sequential/concurrent chemoradiotherapy, and the treatment regimen was pemetrexed 500 mg/m2 (non-squamous carcinoma), D1/nab-paclitaxel 260 mg/m2 (squamous cell carcinoma), D1 + carboplatin AUC5, D1/; Up to 2 cycles, the radiation dose is PTV 54-60Gy/27-30F (primary + lymph nodes). Consolidation therapy: After 3 weeks after the end of chemoradiotherapy, the consolidation therapy stage was entered, and the immune standard consolidation therapy was selected according to the voluntary principle of the clinician and the subject, and the subject received consolidation therapy until disease progression, intolerable toxic side effects, withdrawal or the investigator's decision to let the subject withdraw from the study, non-compliance with the study treatment or other reasons specified in the study procedures or protocol, up to 14 cycles.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	湖北	市(区县)：	武汉
Country：	China	Province：	Hubei	City：	Wuhan
单位(医院)：	华中科技大学同济医学院附属协和医院	单位级别：	三甲
Institution hospital：	Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	1年PFS率	指标类型：	主要指标
Outcome：	1 year PFS ratio	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	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	指标类型：	次要指标
Outcome：	Overall 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：	缓解持续时间	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：	疾病控制率	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：	总生存期	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：

采集人体标本：

Collecting sample(s)
from participants：

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	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:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是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）：	临床试验公共管理平台 http://www.medresman.org.cn，在试验结束6个月内上传试验数据。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Clinical Trial Management Public Platform http://www.medresman.org.cn, trial data were uploaded within 6 months of the end of the trial.
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：	暂未确定/Not yet
注册人： Name of Registration：	2025-01-08 15:14:47