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：	ChiCTR2500096580
最近更新日期： Date of Last Refreshed on：	2025-01-26 11:28:28
注册时间： Date of Registration：	2025-01-26 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	依沃西单抗联合化疗治疗晚期NSCLC肝转移患者的前瞻性、开放、单臂、单中心Ⅱ 期临床研究
Public title：	A prospective, open-label, single-arm, single-center phase II clinical study of Ivonescimab combined with chemotherapy in patients with advanced NSCLC and liver metastases.
注册题目简写：
English Acronym：
研究课题的正式科学名称：	依沃西单抗联合化疗治疗晚期NSCLC肝转移患者的前瞻性、开放、单臂、单中心Ⅱ 期临床研究
Scientific title：	A prospective, open-label, single-arm, single-center phase II clinical study of Ivonescimab combined with chemotherapy in patients with advanced NSCLC and liver metastases.
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：	张雨晴	研究负责人：	贾敬好
Applicant：	Zhang Yuqing	Study leader：	Jia Jinghao
申请注册联系人电话： Applicant telephone：	+86 181 3235 6472	研究负责人电话： Study leader's telephone：	+86 189 3150 6355
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：	jjh0322@163.com	研究负责人电子邮件： Study leader's E-mail：	jjh0322@163.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：	河北省唐山市路北区建设南路73号	研究负责人通讯地址：	河北省唐山市路北区建设南路73号
Applicant address：	73 Jianshe Road South, Lubei District, Tangshan, Hebei	Study leader's address：	73 Jianshe Road South, Lubei District, Tangshan, Hebei
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：	华北理工大学附属医院
Applicant's institution：	North China University of Science and Technology Affiliated Hospital
研究负责人所在单位：	华北理工大学附属医院
Affiliation of the Leader：	North China University of Science and Technology Affiliated 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：	20241226032	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：	华北理工大学附属医院临床医学研究伦理委员会
Name of the ethic committee：	The Clinical Medical Research Ethics Committee of North China University of Science and Technology Affiliated Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-12-26 00:00:00
伦理委员会联系人：	李少燕
Contact Name of the ethic committee：	Li Shaoyan
伦理委员会联系地址：	河北省唐山市路北区建设南路73号
Contact Address of the ethic committee：	73 Jianshe Road South, Lubei District, Tangshan, Hebei +86 15383055660
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 153 8305 5660	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：

华北理工大学附属医院

Primary sponsor：

North China University of Science and Technology Affiliated Hospital

研究实施负责（组长）单位地址：

河北省唐山市路北区建设南路73号

Primary sponsor's address：

73 Jianshe Road South, Lubei District, Tangshan, Hebei

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	河北	市(区县)：	唐山
Country：	China	Province：	Hebei	City：	Tangshan
单位(医院)：	华北理工大学附属医院	具体地址：	路北区建设南路73号
Institution hospital：	North China University of Science and Technology Affiliated Hospital	Address：	73 Jianshe Road South, Lubei District

经费或物资来源：

自筹

Source(s) of funding：

self-funded

研究疾病：

肺癌

Target disease：

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：

评价依沃西单抗联合化疗治疗晚期NSCLC肝转移的有效性和安全性。

Objectives of Study：

To evaluate the efficacy and safety of Ivonescimab in combination with chemotherapy for the treatment of advanced NSCLC with liver metastases.

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.	The participant has been thoroughly informed about the study and has voluntarily signed the informed consent form (ICF).
2.	Age >= 18 years, with no restriction on gender.
3.	An expected survival of more than 3 months.
4.	Presence of at least one measurable lesion as defined by RECIST v1.1.
5.	Histologically or cytologically confirmed Stage IV metastatic or recurrent NSCLC with liver metastases, according to the 8th edition of the TNM classification by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).
6.	Eastern Cooperative Oncology Group (ECOG) performance status of 0–1.
7.	Patients who have previously received platinum-based adjuvant or neoadjuvant chemoradiotherapy, or radical chemoradiotherapy for advanced disease, and whose disease progression occurred more than 6 months after their most recent treatment, are eligible to participate in this study.
8.	Adequate hematologic function, defined as: absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelet count >= 100 × 10^9/L, and hemoglobin >= 90 g/L (with no blood transfusions in the preceding 7 days).
9.	Adequate liver function, defined as: total bilirubin <= 1.5 × the upper limit of normal (ULN), and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 2.5 × ULN for all patients, or <= 5 × ULN for those with liver metastases.
10.	Adequate renal function, defined as: serum creatinine <= 1.5 × ULN, estimated creatinine clearance (CrCl) >= 50 mL/min, and urine protein < 2+ or 24-hour urine protein < 1.0 g.
11.	Adequate coagulation function, defined as: international normalized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN. If the participant is receiving anticoagulant therapy, the INR/PT should remain within the intended therapeutic range of the anticoagulant.
12.	Women of childbearing potential must test negative for pregnancy within 7 days prior to initiating treatment. Both female and male participants of childbearing potential must use reliable contraceptive methods (e.g., intrauterine device, oral contraceptives, or condoms) from the start of the study until 30 days after study completion. Male participants are required to use condoms during the same period.
13.	Able to comply with scheduled follow-up visits and adhere to the protocol requirements.

排除标准：

1) 当前正在参与干预性临床研究治疗； 2) 大细胞癌及混合细胞肺癌，混有小细胞肺癌成份的患者； 3) 既往接受过免疫治疗，包括免疫检查点抑制剂（如：抗PD-1/L1抗体、抗CTLA-4抗体、抗LAG-3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的受试者； 4) 已知会对任何研究药物或其任何辅料产生过敏反应或超敏反应； 5) 有严重出血倾向或凝血功能障碍病史；首次给药前1个月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）；筛选期影像学显示肿瘤包绕重要血管或存在明显坏死、空洞，且研究者判定进入研究会引起出血风险；中央型、存在空洞的鳞状NSCLC且研究者判断出血风险较高；首次给药前10天内接受过持续的抗血小板或抗凝治疗； 6) 肿瘤侵犯周围重要脏器及血管（如主动脉、心脏及心包、上腔静脉、气管、食管等）或存在发生食管气管瘘或食管胸膜瘘风险； 7) 伴有不可控制的需要反复引流的胸腔积液、心包积液或腹水的受试者（不需要引流积液或引流的频率每月小于 1 次的受试者可入组）； 8) 有症状的脑转移、脑膜转移或脊髓压迫患者； 9) 存在需要系统性糖皮质激素治疗的非感染性肺炎/间质性肺疾病病史或当前存在非感染性肺炎； 10) 严重合并症如严重的肺部或心脏疾病病史，在入选治疗前 6 个月内发生过任何动脉血栓、栓塞或缺血，如心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作等。在入组前 3 个月内有深静脉血栓、肺栓塞或其它任何严重血栓栓塞的病史（植入式静脉输液港或导管源性血栓形成，或浅表静脉血栓形成不被视为“严重”血栓栓塞）； 11) 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。接受稳定的胰岛素治疗方案后得到控制的1型糖尿病患者有资格参加本研究； 12) 活动性的全身感染，包括结核（临床诊断包括临床病史、体格检查和影像学发现，以及根据当地医疗常规进行的TB检查）、乙型肝炎（已知HBV表面抗原（HBsAg）阳性，且HBV DNA ≥1000cps/ml或其参考值下限）、丙型肝炎或人免疫缺陷病毒（HIV抗体阳性）； 13) 已知存在可能对遵从试验要求产生影响的精神疾病或药物滥用情况； 14）存在可能干扰试验结果、妨碍受试者全程参与研究的病史、疾病、治疗或实验室异常结果，或研究者认为参与研究不符合受试者的最大利益。

Exclusion criteria：

1. Currently participating in another interventional clinical study. 2. Diagnosis of large cell carcinoma or mixed-type lung cancer that includes a small cell lung cancer component. 3. Prior exposure to any immunotherapy targeting tumor immune mechanisms (e.g., immune checkpoint inhibitors such as anti-PD-1/L1 or anti-CTLA-4 antibodies, immune checkpoint agonists such as ICOS, CD40, CD137, GITR, or OX40 antibodies, or any form of immune cell therapy). 4. Known allergy or hypersensitivity to any study drug or its excipients. 5. A history of severe bleeding tendency or coagulopathy; or clinically significant bleeding within 1 month before the first dose, including but not limited to gastrointestinal bleeding or hemoptysis (defined as coughing up >=1 teaspoon of fresh blood or blood clots, or hemoptysis without sputum—note that blood-tinged sputum is allowed), or significant epistaxis (excluding minor nosebleeds or retracted nasal bleeding). Patients whose screening imaging shows tumor encasement of major blood vessels or obvious necrosis/cavitation deemed to carry a high risk of hemorrhage (according to the investigator’s judgment) are also excluded. Likewise, patients with centrally located, cavitary squamous NSCLC at high risk of bleeding are excluded. Continuous use of antiplatelet or anticoagulant therapy within 10 days before the first dose is not permitted. 6. Tumor invasion of critical adjacent organs or vessels (such as the aorta, heart/pericardium, superior vena cava, trachea, or esophagus), presenting a risk of esophagotracheal or esophagopleural fistula as judged by the investigator. 7. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. (Patients who do not require drainage or whose drainage frequency is less than once per month may be enrolled.) 8. Symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression. 9. A history of non-infectious pneumonitis/interstitial lung disease requiring systemic corticosteroids, or current non-infectious pneumonitis. 10. Severe comorbidities (e.g., severe pulmonary or cardiac diseases). Any history of arterial thrombosis, embolism, or ischemia (including myocardial infarction, unstable angina, stroke, or transient ischemic attack) within 6 months before the start of study treatment. Any history of deep vein thrombosis, pulmonary embolism, or other severe thromboembolic events within 3 months before the start of study treatment. (Thrombosis associated with an implanted intravenous access port or catheter, or superficial venous thrombosis, is not considered a "severe" thromboembolic event.) 11. A history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-related vascular thrombosis, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Subjects with autoimmune-related hypothyroidism who are on a stable dose of thyroid hormone replacement are eligible. Subjects with type 1 diabetes controlled by a stable insulin regimen are also eligible. 12. Active systemic infection, including tuberculosis (diagnosed according to local clinical practice, e.g., history, physical examination, imaging, and TB testing), hepatitis B (HBsAg positive with HBV DNA >= 1000 cps/mL or per local reference values), hepatitis C, or HIV (positive for HIV antibodies). 13. Known psychiatric disorder or substance abuse that could interfere with compliance to study requirements. 14. Any history, condition, treatment, or laboratory abnormality that, in the investigator’s judgment, could interfere with the study results, prevent the subject from participating fully, or not be in the subject’s best interest.

研究实施时间：

Study execute time：

从 From 2025-01-10 00:00:00至 To 2027-05-20 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-02-20 00:00:00 至 To 2027-02-20 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	30
Group：	Experimental group	Sample size：	30
干预措施：	依沃西单抗联合化疗治疗	干预措施代码：
Intervention：	Ivonescimab in combination with chemotherapy.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	河北	市(区县)：	唐山
Country：	China	Province：	Hebei	City：	Tangshan
单位(医院)：	华北理工大学附属医院	单位级别：	三甲
Institution hospital：	North China University of Science and Technology Affiliated Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	客观缓解率	指标类型：	主要指标
Outcome：	Overall response rate	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	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：	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：	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：	无进展生存期	指标类型：	次要指标
Outcome：	Progression-Free-Survival Time	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	不良事件发生率	指标类型：	副作用指标
Outcome：	Adverse event rate	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：	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：

标本中文名：	尿液	组织：
Sample Name：	Urine	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：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age		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）：

无随机

Randomization Procedure (please state who generates the random number sequence and by what method)：

no randomization

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）：	试验未开始招募
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	No enrollment yet
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：	Case Record Form, CRF
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：	2025-01-26 11:28:10