ChiCTR2600117077 版本V1.0 版本创建时间2026/01/19 18:00:01 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：

 ChiCTR2600117077 

最近更新日期：

Date of Last Refreshed on：

 2026-01-19 17:59:18 

注册时间：

Date of Registration：

 2026-01-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评估甲磺酸阿美替尼一线治疗EGFR突变IIIB-IV 期非鳞 NSCLC患者合并慢性阻塞性肺疾病的有效性及安全性研究

Public title：

A study evaluating the efficacy and safety of aumolertinib mesylate as first-line therapy in patients with EGFR-mutated stage IIIB-IV non-squamous non-small cell lung cancer (NSCLC) complicated by chronic obstructive pulmonary disease (COPD)

注册题目简写：

阿美替尼一线治疗合并慢阻肺的EGFR突变晚期非鳞肺癌的疗效与安全性研究

English Acronym：

A Study on the Efficacy and Safety of Osimertinib Mesylate as First-Line Therapy for EGFR-Mutated Advanced Non-Squamous Non-Small Cell Lung Cancer Patients with Chronic Obstructive Pulmonary Disease

研究课题的正式科学名称：

一项评估甲磺酸阿美替尼一线治疗EGFR突变IIIB-IV 期非鳞 NSCLC患者合并慢性阻塞性肺疾病的有效性及安全性研究

Scientific title：

A study evaluating the efficacy and safety of aumolertinib mesylate as first-line therapy in patients with EGFR-mutated stage IIIB-IV non-squamous non-small cell lung cancer (NSCLC) complicated by chronic obstructive pulmonary disease (COPD)

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：

马晖 

研究负责人：

马晖 

Applicant：

MaHui 

Study leader：

MaHui 

申请注册联系人电话：

Applicant telephone：

 +86 138 2122 9457

研究负责人电话：

Study leader's
telephone：

+86 22 8818 5009

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：

 mahuitj@126.com

研究负责人电子邮件：

Study leader's E-mail：

 mahuitj@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：

天津市津南区台儿庄南路261号

研究负责人通讯地址：

天津市津南区台儿庄南路261号；天津市和平区西安道93号

Applicant address：

No. 261, Taiwanzhuang South Road, Jinnan District, Tianjin City

Study leader's address：

No. 261, Taierzhuang South Road, Jinnan District, Tianjin

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：

天津市胸科医院

Applicant's institution：

Tianjin Chest Hospital

研究负责人所在单位：

天津市胸科医院

Affiliation of the Leader：

Tianjin Chest Hospital

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：

 2025KY-041-01

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：

天津市胸科医院伦理审查委员会

Name of the ethic committee：

TIANJIN CHEST HOSPITAL ETHIC COMMITTEE

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-09-25 00:00:00

伦理委员会联系人：

庞若男

Contact Name of the ethic committee：

Pang RuoNan

伦理委员会联系地址：

天津市津南区台儿庄南路261号；天津市和平区西安道93号

Contact Address of the ethic committee：

No. 261, Taierzhuang South Road, Jinnan District, Tianjin

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 22 8818 5557

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 18920281226@163.com

研究实施负责（组长）单位：

天津市胸科医院

Primary sponsor：

Tianjin Chest Hospital

研究实施负责（组长）单位地址：

天津市津南区台儿庄南路261号；天津市和平区西安道93号

Primary sponsor's address：

No. 261, Taierzhuang South Road, Jinnan District, Tianjin

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

天津市

市(区县)：

Country：

China

Province：

Tianjin

City：

单位(医院)：

天津市胸科医院

具体地址：

天津市津南区台儿庄南路261号；天津市和平区西安道93号

Institution
hospital：

Tianjin Chest Hospital

Address：

No. 261, Taierzhuang South Road, Jinnan District, Tianjin

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected Topic (Self-funded)

研究疾病：

EGFR突变IIIB-IV期非鳞 NSCLC 合并慢阻肺  

Target disease：

EGFR-mutated stage IIIB-IV non-squamous NSCLC complicated by COPD

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：

目前EGFR突变的NSCLC合并COPD患者的治疗研究较少，缺乏前瞻性的临床研究。在肺癌抗肿瘤药物治疗中，化疗、靶向治疗、抗血管生成药物及免疫治疗等手段都扮演着重要角色。其中，针对驱动基因阳性的非小细胞肺癌（NSCLC）患者，靶向治疗更是颠覆了传统肺癌治疗格局。而对于LC-COPD患者，在控制COPD疾病进展的同时，积极有效的抗肿瘤药物治疗，对于改善患者预后，提升患者生存质量十分重要。探索阿美替尼一线治疗EGFR突变IIIB-IV期非鳞 NSCLC 患者合并慢阻肺的有效性及安全性，为EGFR突变IIIB-IV期非鳞 NSCLC 合并慢阻肺的患者治疗提供临床参考。  

Objectives of Study：

Currently, there are few studies on the treatment of NSCLC patients with EGFR mutations complicated by COPD, and prospective clinical studies are lacking. In the anti-tumor drug treatment of lung cancer, chemotherapy, targeted therapy, anti-angiogenic drugs, immunotherapy and other methods all play important roles. Among them, for non-small cell lung cancer (NSCLC) patients with positive driver genes, targeted therapy has subverted the traditional pattern of lung cancer treatment. For LC-COPD patients, while controlling the progression of COPD, active and effective anti-tumor drug treatment is crucial for improving patient prognosis and quality of life. This study aims to explore the efficacy and safety of aumolertinib as first-line treatment for EGFR-mutated stage IIIB-IV non-squamous NSCLC patients complicated by COPD, so as to provide clinical reference for the treatment of such patients.

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.对本研究已充分了解并自愿签署知情同意书（ICF）；
2.年龄18岁-75岁，性别不限；
3.经组织学和/或细胞学确诊的晚期或复发IIIB-IV期非鳞 NSCLC 患者（根据AJCC第8版分期系统）伴EGFR突变；
4.至少有一个可测量病灶（根据RECIST 1.1）； 注：之前接受过放疗的病灶不可视为靶病灶，除非放疗病灶发生明确进展。
5.根据东部肿瘤协作组（ECOG）标准，体能状态评分为0或1；
6.预期生存期≥3月；
7.良好的器官功能： 1）血常规检查：（筛查前14天内未输血、未使用G-CSF、未使用药物纠正） ?血红蛋白（HB）≥90 g/L； ?中性粒细胞计数绝对值（ANC）≥1.5×109/L； ?血小板计数（PLT）≥100×109/L； ?白细胞计数（WBC）≥4.0×109/L或本研究中心的正常值下限，并且≤15×109/L； 2）生化检查：（筛查前14天内未输血或白蛋白） ?AST和ALT≤1.5 x ULN（如存在肿瘤肝转移，≤5 x ULN）； ?ALP≤2.5 x ULN（如存在肿瘤骨转移，≤5 x ULN）； ?TBiL≤1.5 x ULN； ?ALB≥30 g/L； ?Cr≤1.5 x ULN，同时肌酐清除率(CrCL)≥60 mL/min（顺铂）或CrCL ≥50 mL/min（卡铂）（Cockcroft-Gault公式）； ?APTT≤1.5 x ULN，同时INR或PT≤1.5 x ULN（未接受抗凝治疗）；
8.任何既往治疗、手术或放疗导致的不良事件必须已缓解至0或1级（根据美国国家癌症研究所-不良事件通用术语标准（NCI-CTCAE 5.0），任何等级的脱发除外；
9.愿意并能够遵守研究计划的访视、治疗计划、实验室检查和其他研究程序；
10.育龄妇女必须在首次用药前3天内进行血清妊娠试验，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在研究期间和末次给予研究药物后180天内采用高效方法避孕。

Inclusion criteria

1.?Has a full understanding of the study and voluntarily signs the Informed Consent Form (ICF); 2.?Aged 18 to 75 years old, regardless of gender; 3.?Histologically and/or cytologically confirmed advanced or recurrent stage IIIB-IV non-squamous NSCLC patients with EGFR mutations (per the 8th edition of the AJCC staging system); 4.?Has at least one measurable lesion (per RECIST 1.1); 1.Note: Lesions previously treated with radiotherapy shall not be regarded as target lesions unless there is clear progression of the irradiated lesions. 5.?Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 6.?Expected survival of >= 3 months; 7.?Adequate organ function: (1).?Hematological tests (no blood transfusion, G-CSF administration, or corrective drugs used within 14 days before screening): - Hemoglobin (HB) >= 90 g/L; 2.- Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; 3.- Platelet count (PLT) >= 100 × 10^9/L; 4.- White blood cell count (WBC) >= 4.0 × 10^9/L or the lower limit of normal (LLN) at the study center, and <= 15 × 10^9/L; 5.(2).?Biochemical tests (no blood transfusion or albumin administration within 14 days before screening): - AST and ALT <= 1.5 × ULN (<= 5 × ULN if there is tumor liver metastasis); 6.- ALP <= 2.5 × ULN (<= 5 × ULN if there is tumor bone metastasis); 7.- Total bilirubin (TBiL) <= 1.5 × ULN; 8.- Albumin (ALB) >= 30 g/L; 9.- Creatinine (Cr) <= 1.5 × ULN, with creatinine clearance (CrCL) >= 60 mL/min (for cisplatin) or CrCL >= 50 mL/min (for carboplatin) (calculated by the Cockcroft-Gault formula); 10.- Activated partial thromboplastin time (APTT) <= 1.5 × ULN, and international normalized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN (for subjects not receiving anticoagulant therapy); 8.?Adverse events resulting from any prior treatment, surgery, or radiotherapy must have resolved to grade 0 or 1 (per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0), except for alopecia of any grade; 9.?Willing and able to comply with the study’s visit schedule, treatment plan, laboratory tests, and other study procedures; 10.?Women of childbearing potential must have a negative serum pregnancy test within 3 days before the first dose of study drug. Women of childbearing potential and male subjects whose partners are of childbearing potential must agree to use highly effective contraceptive methods during the study and for 180 days after the last dose of study drug.

排除标准：

1.目标疾病排除标准 1）排除肿瘤组织学或细胞学病理证实合并小细胞肺癌成分，或鳞癌成分超过10%； 2）合并其他有已知药物治疗的驱动基因突变，包括但不仅限于：ALK基因重排、ROS1突变、BRAF600E突变、NTRK融合突变、MET14外显子跳跃突变、RET融合突变、KRAS G12C/HER2突变； 3）既往接受过针对晚期NSCLC的系统化疗； 4）排除无可测量病灶受试者； 5）排除有癌性脑膜炎、脊髓压迫等情况的受试者。未针对脊髓压迫进行明确的手术和/或放疗，或对于既往诊断和治疗的脊髓压迫，无证据表明随机化前疾病在临床上稳定≥2周； 6）患者曾经接受过抗血管生成药物治疗； 7）患者在首次给药之前4周接受其他已批准的全身性抗癌治疗或全身性免疫调节剂（包括但不限于干扰素、白介素2和肿瘤坏死因子）。 2.病史和合并症 1）排除存在任何活动性、已知或可疑自身免疫疾病的受试者。自身免疫性疾病病史，包括但不限于重症肌无力、肌炎、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、与抗磷脂综合征有关的血管血栓形成、韦格纳肉芽肿病、干燥综合征、格林-巴利综合征、多发性硬化、血管炎或肾小球肾炎； ?有自身免疫相关甲状腺功能减退的患者接受稳定剂量甲状腺激素替代治疗的有资格参加本研究。 ?患有白癜风或在童年期哮喘已完全缓解，成人后无需任何干预的患者可纳入。 2）排除首次用药前1个月内用过抗肿瘤疫苗或其他具有免疫刺激作用的抗肿瘤药（干扰素、白介素、胸腺肽、免疫细胞疗法等）治疗的受试者； 3）排除正在参加其他临床研究或首次用药时间距离前一项临床研究结束（末次给药）时间少于4周（或该研究药物的5个半衰期）的受试者； 4）排除预期在研究中需要任何其它形式的抗肿瘤治疗（包括其它NSCLC药物的维持治疗、放疗和/或手术切除）的受试者； 5）入组前4周内进行过外科大手术或尚未从之前的手术中完全恢复的受试者； 6）首次用药前4周内>30 Gy的非胸部放射治疗者，首次用药前胸部放射者； 7）排除高度怀疑有间质性肺炎的受试者；或可能会干扰可疑的药物相关肺毒性的检测或处理的受试者；或其他严重影响肺功能的中重度肺部疾病； 8）排除需要同时治疗的其他活动性恶性肿瘤的受试者； 9）排除首次用药前5年内患有除非小细胞肺癌癌之外的其它恶性肿瘤。转移或死亡风险可忽略（例如，预期的5年OS>90%）且治疗后预期可获得根治性结果的恶性肿瘤（例如，充分治疗的宫颈原位癌、基底或鳞状细胞皮肤癌、根治性目的治疗的局限性前列腺癌、根治性目的手术治疗的原位导管癌）可除外； 10）排除患有Ⅱ级以上心肌缺血或心肌梗塞、控制不良的心律失常的受试者。排除按照NYHA标准Ⅲ～Ⅳ级心功能不全或心脏彩超检查：LVEF（左室射血分数）＜50%的受试者； 11）患有活动性肺结核（TB）的患者，正在接受抗结核治疗或者筛选前1年内接受过抗结核治疗； 12）排除首次用药前4周内发生过严重感染的受试者，包括但不局限于需要住院治疗的感染并发症，菌血症，重症肺炎等。排除伴有任何活动性感染的受试者。不排除肺癌淋巴扩散的情况； 13）排除准备进行或者既往接受过组织/器官移植的受试者； 14）排除首次用药前30天内接种过或将接种活疫苗的受试者； 15）排除首次用药前伴有铂类药物治疗禁忌症的受试者：痛风（针对使用顺铂的受试者）、水痘、带状疱疹、≥2级外周神经病变； 16）未控制的胸腔积液、心包积液，或需要反复引流的腹水（一月一次或更频繁）； 17）排除伴有未控制的肿瘤相关疼痛的受试者。需要止痛药治疗的受试者必须在随机分组前已有稳定的止痛治疗方案；适合姑息性放疗的症状性病灶（如骨转移或转移侵犯神经）应在入选至少2周前完成治疗；无症状的转移性病灶，如果其进一步生长可能会导致功能障碍或顽固性疼痛（如没有表现出脊髓压迫的硬膜外转移）； 3.查体和实验室检查所见 1）已知有人类免疫缺陷病毒（HIV）检查阳性病史或已知有获得性免疫缺陷综合征（艾滋病）； 2）未经治疗的活动性肝炎。乙肝：乙型肝炎病毒表面抗原（HBsAg）阳性且HBV DNA检测值高于正常值上限；丙肝：丙型肝炎病毒抗体（HCV Ab）阳性，HCV RNA阳性；合并乙肝和丙肝共同感染； 注：乙肝核心抗体（HBcAb）阳性者，也需检测HBV-DNA， HBV DNA检测值低于正常值上限才可入组； 4.过敏反应和药物不良反应； 5.排除伴有精神疾病、酗酒、吸毒或药物滥用等情况的受试者； 6.根据研究者的判断，排除患有可能混淆研究结果、干扰受试者参与研究程序或不符合受试者参加研究最佳利益的任何疾病、治疗或实验室异常的病史或当前证据的受试者。

Exclusion criteria：

1. Exclusion Criteria for Target Disease 1).?Exclusion of subjects with tumor histologically or cytologically confirmed to have small cell lung cancer components, or squamous cell carcinoma components exceeding 10%; 2).?Concomitant with other driver gene mutations with known drug treatments, including but not limited to: ALK gene rearrangement, ROS1 mutation, BRAF600E mutation, NTRK fusion mutation, MET exon 14 skipping mutation, RET fusion mutation, KRAS G12C/HER2 mutation; 3).?Prior receipt of systemic chemotherapy for advanced NSCLC; 4).?Exclusion of subjects without measurable lesions; 5).?Exclusion of subjects with carcinomatous meningitis, spinal cord compression, etc. No definitive surgery and/or radiotherapy has been performed for spinal cord compression, or for previously diagnosed and treated spinal cord compression, there is no evidence that the disease has been clinically stable for >= 2 weeks before randomization; 6).?Patients who have received anti-angiogenic drug therapy; 7).?Patients who received other approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin-2, and tumor necrosis factor) within 4 weeks before the first dose. 2. Medical History and Comorbidities 1).?Exclusion of subjects with any active, known or suspected autoimmune disease. History of autoimmune diseases includes but is not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sj?gren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis; 1).- Patients with autoimmune-related hypothyroidism receiving a stable dose of thyroid hormone replacement therapy are eligible for the study. - Patients with vitiligo or asthma that completely resolved in childhood and required no intervention in adulthood may be included. 2).?Exclusion of subjects who received anti-tumor vaccines or other anti-tumor drugs with immunostimulatory effects (interferon, interleukin, thymosin, immune cell therapy, etc.) within 1 month before the first dose; 3).?Exclusion of subjects who are participating in other clinical studies or whose first dose is less than 4 weeks (or 5 half-lives of the study drug) after the end of the previous clinical study (last dose); 4).?Exclusion of subjects expected to require any other form of anti-tumor treatment during the study (including maintenance therapy with other NSCLC drugs, radiotherapy and/or surgical resection); 5).?Subjects who underwent major surgery within 4 weeks before enrollment or have not fully recovered from previous surgery; 6).?Subjects who received non-thoracic radiotherapy > 30 Gy within 4 weeks before the first dose, or thoracic radiotherapy before the first dose; 7).?Exclusion of subjects with highly suspected interstitial pneumonia; or subjects who may interfere with the detection or management of suspected drug-related pulmonary toxicity; or other moderate to severe pulmonary diseases that seriously affect lung function; 8).?Exclusion of subjects with other active malignant tumors requiring concurrent treatment; 9).?Exclusion of subjects with other malignant tumors except non-small cell lung cancer within 5 years before the first dose. Malignant tumors with negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) and expected curative outcomes after treatment (e.g., adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, ductal carcinoma in situ treated with curative surgery) are excluded from this exclusion criterion; 10).?Exclusion of subjects with grade II or higher myocardial ischemia or myocardial infarction, or uncontrolled arrhythmia. Exclusion of subjects with NYHA class III-IV heart failure or left ventricular ejection fraction (LVEF) < 50% by echocardiography; 11).?Patients with active tuberculosis (TB) who are receiving anti-TB treatment or have received anti-TB treatment within 1 year before screening; 12).?Exclusion of subjects who had a severe infection within 4 weeks before the first dose, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc. Exclusion of subjects with any active infection. Lymphatic spread of lung cancer is not excluded; 13).?Exclusion of subjects planning to undergo or having previously received tissue/organ transplantation; 14).?Exclusion of subjects who received or will receive live vaccines within 30 days before the first dose; 15).?Exclusion of subjects with contraindications to platinum-based drug therapy before the first dose: gout (for subjects receiving cisplatin), chickenpox, herpes zoster, grade >= 2 peripheral neuropathy; 16).?Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently); 17).?Exclusion of subjects with uncontrolled tumor-related pain. Subjects requiring analgesic treatment must have a stable analgesic regimen before randomization;symptomatic lesions suitable for palliative radiotherapy (e.g., bone metastases or metastatic nerve invasion) should be treated at least 2 weeks before enrollment; asymptomatic metastatic lesions that may lead to dysfunction or intractable pain if further growth occurs (e.g., epidural metastases without spinal cord compression). 3. Physical Examination and Laboratory Findings 1).?Known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); 2).?Untreated active hepatitis. Hepatitis B: positive hepatitis B surface antigen (HBsAg) and HBV DNA test value above the upper limit of normal (ULN); Hepatitis C: positive hepatitis C virus antibody (HCV Ab) and positive HCV RNA; coinfection with hepatitis B and C; Note: For subjects with positive hepatitis B core antibody (HBcAb), HBV-DNA must also be tested, and only those with HBV DNA test value below the upper limit of normal can be enrolled. 4. Allergic Reactions and Adverse Drug Reactions Exclusion of subjects with a history of severe allergic reactions to the study drug or its excipients (to be specified according to the actual study drug). 5. Other Exclusions Exclusion of subjects with mental illness, alcoholism, drug addiction or substance abuse. 6. Investigator's Judgment Exclusion of subjects with a history or current evidence of any disease, treatment or laboratory abnormality that may confound study results, interfere with the subject's participation in study procedures, or is not in the subject's best interest to participate in the study, as judged by the investigator.

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

从 From 2026-01-20 00:00:00 至 To 2027-01-20 00:00:00

干预措施：

Interventions：

组别：

甲磺酸阿美替尼一线治疗组

样本量：

 51

Group：

Aumolertinib Mesylate First-Line Treatment Group

Sample size：

干预措施：

甲磺酸阿美替尼

干预措施代码：

Intervention：

Aumolertinib Mesylate

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 天津市 

市(区县)：

  

Country：

China

Province：

Tianjin

City：

单位(医院)：

 天津市胸科医院 

单位级别：

 三级甲等 

Institution
hospital：

Tianjin Chest Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

与研究药物相关的不良事件（AE）、实验室检查异常值、严重不良事件（SAE）

指标类型：

次要指标

Outcome：

Adverse Events (AEs) related to the study drug，Abnormal laboratory test values，Serious Adverse Events (SAEs)

Type：

Secondary indicator

测量时间点：

依据NCI CTCAE V5.0，应观察并记录从首次用药开始直至末次用药后的30天所发生的所有不良事件。SAE收集至末次用药后90天、或开始新的抗肿瘤治疗，以先发生者为准。但受试者若在末次用药后30天

测量方法：

所有受试者在研究期间发生的任何不良事件，包括临床症状及生命体征异常、实验室检查中出现的异常，记录其临床表现特征、严重程度、发生时间、持续时间、处理方法及预后，并判定其与研究药物之间的相关性。实验室值(如血液学、临床化学、尿液分析)、生命体征、心电图和体格检查将用于安全性评估。使用描述性统计对安全分析集中的所有安全数据进行分析。

Measure time point of outcome：

All adverse events occurring from the first dose until 30 days after the last dose should be observe

Measure method：

Any adverse events occurring in all subjects during the study, including clinical symptoms, abnormal vital signs, and abnormalities in laboratory tests, should be recorded for their clinical manifestations, severity, onset time, duration, management methods, and prognosis, with the correlation between each event and the study drug determined. Laboratory values (such as hematology, clinical chemistry, and urinalysis), vital signs, electrocardiograms (ECGs), and physical examinations will be used

指标中文名：

无进展生存期

指标类型：

主要指标

Outcome：

Progression-Free Survival（PFS）

Type：

Primary indicator

测量时间点：

肿瘤评估采用RECIST 1.1标准，分别在筛选时（作为基线），首次用药后8周（±7天），之后每12周（±7天）评估一次，直至出现客观疾病进展。因非疾病进展原因终止研究治疗的，仍需按照上述频率继续肿瘤

测量方法：

研究将根据实体瘤疗效评价标准RECIST1.1版评价治疗疗效，对PFS以及95%置信区间（CI）进行计算。

Measure time point of outcome：

Tumor assessment will be performed in accordance with the RECIST 1.1 criteria at screening (as basel

Measure method：

The study will evaluate treatment efficacy in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, and calculate Progression-Free Survival (PFS) along with its 95% Confidence Interval (CI).

指标中文名：

疾病控制率（DCR）、总生存期（OS）及持续缓解时间（DOR）

指标类型：

次要指标

Outcome：

Disease Control Rate (DCR)，Overall Survival (OS)，Duration of Response (DoR)

Type：

Secondary indicator

测量时间点：

以实体瘤疗效评价标准（RECIST）V1.1为评价标准，筛选期影像学评价于首次用药前28天内进行，后续影像学评价将在首次给药后8周（±7天），之后12周（±7天）进行一次。

测量方法：

对于DCR将进行点估计，并采用Clopper-Pearson法计算其双侧95%CI。对于OS以及DOR，将采用KM方法估计生存曲线和相应的分位数。如果适用的话，将采用Brookmeyer Crowley方法计算相应指标中位数的双侧95%CI。

Measure time point of outcome：

Efficacy will be evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST) Versio

Measure method：

Point estimation will be performed for Disease Control Rate (DCR), and its two-sided 95% Confidence Interval (CI) will be calculated using the Clopper-Pearson method. For Overall Survival (OS) and Duration of Response (DoR), the Kaplan-Meier (KM) method will be used to estimate survival curves and corresponding quantiles. If applicable, the Brookmeyer-Crowley method will be employed to calculate the two-sided 95% CI for the median of the respective indicators.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血清

组织：

Sample Name：

Serum

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：

全血

组织：

Sample Name：

Whole 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:

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）：

无

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

Unknown

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：

本项研究中，受试者数据将录入指定的电子病例报告表系统（eCRF）中，并传送到申办者确认的数据系统中与其它来源的数据进行整合。 临床数据的管理将遵照适用CDISC标准和数据清除程序执行，以确保数据的完整性，如去除错误和不一致的数据。不良事件将使用标准名称医学辞典（MedDRA）,伴随用药名称将使用世界卫生组织药物辞典（WHO Drug）进行编码。eCRF将由申办者保留，拷贝件将作为研究者副本寄给研究者。 研究中心工作人员应负责填写eCRF。对所有签署ICF的受试者，研究者或者授权工作人员均须认真、详细记录eCRF中的任何项目，不得空项、漏项（无记录的空格应按实际情况填写UK/NA/ND）；eCRF中所有数据须与患者原始资料的数据核对，保证无误。 研究者须将原始化验单或复印件粘贴在受试者的研究病历上；对于异常实验室或检查数据，研究者须加以核实，并说明是否具有临床意义；研究者应严格参照eCRF填写说明进行填写。

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

In this study, subject data will be entered into the designated electronic Case Report Form (eCRF) system and transmitted to the sponsor-validated data system for integration with data from other sources. Clinical data management will be performed in accordance with applicable CDISC standards and data cleaning procedures to ensure data integrity, such as removing erroneous and inconsistent data. Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and concomitant medication names will be coded using the World Health Organization Drug Dictionary (WHO Drug). The eCRFs will be retained by the sponsor, and copies will be sent to investigators as investigator copies. Staff at the study center shall be responsible for completing the eCRFs. For all subjects who have signed the Informed Consent Form (ICF), investigators or authorized staff must carefully and detailedly record all items in the eCRFs without blank or missing entries (blank spaces with no records shall be filled with UK/NA/ND as appropriate). All data in the eCRFs must be verified against data in the subjects' original medical records to ensure accuracy. Investigators must attach original laboratory test reports or copies to the subjects' study medical records; for abnormal laboratory or examination data, investigators must verify them and indicate whether they are clinically significant. Investigators shall complete the eCRFs in strict accordance with the eCRF completion instructions.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-01-19 17:59:18