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：	ChiCTR2600121066
最近更新日期： Date of Last Refreshed on：	2026-03-25 09:07:00
注册时间： Date of Registration：	2026-03-25 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	基于类器官药敏结果指导耐药NSCLC患者化疗的前瞻性开放单中心临床研究
Public title：	Prospective open label single center clinical study guiding chemotherapy in drug-resistant NSCLC patients based on organoid drug sensitivity results
注册题目简写：
English Acronym：
研究课题的正式科学名称：	基于类器官药敏结果指导耐药NSCLC患者化疗的前瞻性开放单中心临床研究
Scientific title：	Prospective open label single center clinical study guiding chemotherapy in drug-resistant NSCLC patients based on organoid drug sensitivity results
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：	刘雅琴	研究负责人：	朱波
Applicant：	Liu Yaqin	Study leader：	Zhu Bo
申请注册联系人电话： Applicant telephone：	+86 187 7106 5564	研究负责人电话： Study leader's telephone：	+86 135 9461 1534
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：	liuyq_aya@163.com	研究负责人电子邮件： Study leader's E-mail：	b.davis.zhu@gmail.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：	湖北省武汉市武昌区中北路66号	研究负责人通讯地址：	重庆市沙坪坝区新桥正街83号
Applicant address：	No. 66 Zhongbei Road, Wuchang District, Wuhan City, Hubei Province	Study leader's address：	No. 83 Xinqiao Zhengjie, Shapingba District, Chongqing
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：	北京嘉士腾医学检验实验室有限公司
Applicant's institution：	Kingbio Medical (Beijing) Co., Ltd.
研究负责人所在单位：	陆军军医大学第二附属医院
Affiliation of the Leader：	Second Affiliated Hospital of Army Medical University

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：	2025-研第411-02	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：	中国人民解放军陆军军医大学第二附属医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of the Second Affiliated Hospital of Army Medical University, PLA
伦理委员会批准日期： Date of approved by ethic committee：	2025-12-30 00:00:00
伦理委员会联系人：	宋彩萍
Contact Name of the ethic committee：	Song Caiping
伦理委员会联系地址：	陆军军医大学第二附属医院办公楼二楼医学伦理委员会办公室
Contact Address of the ethic committee：	Office of the Medical Ethics Committee on the Second Floor of the Office Building of the Second Affiliated Hospital of the Army Medical University
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 23 6875 5422	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：

陆军军医大学第二附属医院

Primary sponsor：

Second Affiliated Hospital of Army Medical University

研究实施负责（组长）单位地址：

重庆市沙坪坝区新桥正街83号

Primary sponsor's address：

No. 83 Xinqiao Zhengjie, Shapingba District, Chongqing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	重庆	市(区县)：
Country：	China	Province：	Chongqing	City：
单位(医院)：	陆军军医大学第二附属医院	具体地址：	重庆市沙坪坝区新桥正街83号
Institution hospital：	Second Affiliated Hospital of Army Medical University	Address：	No. 83 Xinqiao Zhengjie, Shapingba District, Chongqing

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	北京嘉士腾医学检验实验室有限公司	具体地址：	北京市昌平区生命科学园生命园路8号院一区15号
Institution hospital：	Kingbio Medical (Beijing) Co., Ltd.	Address：	No. 15, District 1, No. 8 Life Garden Road, Life Science Park, Changping District, Beijing

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

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：

其它

Study phase：

N/A

研究设计：

单臂

Study design：

Single arm

研究目的：

探讨基于类器官药物敏感性检测指导耐药非小细胞肺癌（NSCLC）患者临床治疗的可行性。

Objectives of Study：

Exploring the feasibility of guiding clinical treatment of drug-resistant non-small cell lung cancer (NSCLC) patients based on organoid drug sensitivity testing.

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) Aged 18 to 75 years old (calculated as of the date of signing the informed consent form);
(2) Histopathological diagnosis of non-small cell lung cancer;
(3) After receiving 2-3 rounds of systemic treatment, the disease progressed as assessed by imaging (according to the RECIST 1.1 criteria, disease progression is defined as an increase in the sum of target lesion diameters by >=20% from the lowest value and an absolute increase of >=5mm, or the appearance of new lesions), and subsequent chemotherapy is planned to be administered;
(4) According to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1), at least one lesion (which can be from a single lesion source or a combination of multiple lesions, including but not limited to malignant pleural and peritoneal effusions) that has not undergone radiotherapy or other local therapies and for which tumor tissue is available should be used for organoid establishment;
(5) Hematological examination (results within 7 days prior to the first dose are required for confirmation):
a) Good bone marrow reserve function: absolute neutrophil count (ANC) >=1.5 x 10^9/L, platelet count (PLT) >=90 x 10^9/L, and hemoglobin (HB) >=90 g/L.
b) Good coagulation function: International Normalized Ratio (INR) or Prothrombin Time (PT) <=1.5 x ULN. Activated Partial Thromboplastin Time (aPTT) <=1.5 x ULN.
c) Good liver and kidney function: serum total bilirubin (BILS) <=1.5 x upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 x ULN, and if the patient has liver metastasis, this standard becomes AST and ALT <=5 x ULN. Serum creatinine <=1.5 x ULN;
(6) Good cardiopulmonary function;
(7) ECOG performance status score of 0-2;
(8) Expected survival time > 3 months;
(9) Individuals with reproductive capacity (including male and female patients) agree to adopt effective contraceptive measures approved by the researcher during the trial period and within 3 months after the trial ends (such as intrauterine devices, contraceptive pills, or condoms). For female patients with reproductive capacity, the serum human chorionic gonadotropin test result within 72 hours before study enrollment should be negative;
(10) Patients voluntarily join this study, sign the Informed Consent Form (ICF), demonstrate good compliance, and cooperate with follow-up visits.

排除标准：

（1）全身状态极度衰弱，不能耐受支气管镜检查患者；（2）呼吸道有急性化脓性炎症伴高热，急性哮喘发作和正在咯血者；（3）有间质性肺病、非感染性肺炎或不受控的全身疾病史，包括糖尿病、高血压、肺纤维化、急性肺病等；（4）病理诊断证实合并小细胞肺癌成分；（5）患者伴有活动性软脑膜疾病或脑转移；（6）首次给药前5年内诊断为NSCLC之外的其他恶性疾病（不包括经过根治的皮肤基底细胞癌、皮肤鳞状上皮癌、和/或经过根治性切除的原位癌）；（7）入组前仍存在前次抗肿瘤治疗（手术、放疗、化疗、靶向或免疫疗法）所致的≥2级的急性毒性反应（CTCAE 5.0，脱发除外）；（8）已知异体器官移植（角膜移植除外）或异体造血干细胞移植；（9）合并有心脏功能损害，表现为任何下列状况：控制不良的心包积液；严重心律失常；不稳定性心绞痛；左心室射血分数（LVEF）＜45%；入组前12个月之内发生过心肌梗死；患有或曾患有充血性心力衰竭；既往接受过心脏搭桥手术；具有临床意义的QT间期延长（女性QTc≥470ms，男性QTc≥450ms）；（10）合并有活动性感染，包括活动性结核（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）、人免疫缺陷病毒感染（HIV抗体阳性）、乙型肝炎（已知HBV表面抗原（HBsAg）阳性且HBV DNA≥10^3 copies/mL）、丙型肝炎（已知HCV抗体阳性且HCV-RNA≥10^4 copies/mL）；乙肝和丙肝病情已经抗病毒治疗控制者可以参加本研究；（11）存在任何严重或不能控制的全身性疾病；（12）合并有神经、精神疾患而无法合作或不愿合作者；（13）妊娠期或哺乳期女性患者；（14）28天内接受了任何其他试验用药物治疗或参与了其他临床试验；（15）研究者认为不适合纳入的患者。

Exclusion criteria：

(1) Patients with extremely weakened overall condition and unable to tolerate bronchoscopy; (2) Patients with acute suppurative inflammation of the respiratory tract accompanied by high fever, acute asthma attack, and ongoing hemoptysis; (3) History of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc; (4) Pathological diagnosis confirmed the presence of small cell lung cancer components; (5) Patients with active leptomeningeal disease or brain metastasis; (6) Diagnosed with malignant diseases other than NSCLC within 5 years prior to the first administration (excluding skin basal cell carcinoma, squamous cell carcinoma of the skin, and/or carcinoma in situ that have undergone radical resection); (7) Prior to enrollment, there was still an acute toxicity reaction of grade >=2 (CTCAE 5.0, excluding alopecia) caused by previous anti-tumor treatment (surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy); (8) Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; (9) Concurrent cardiac dysfunction, manifested as any of the following conditions: uncontrolled pericardial effusion; severe arrhythmia; unstable angina; left ventricular ejection fraction (LVEF) <45%; myocardial infarction within 12 months prior to enrollment; current or past congestive heart failure; previous coronary artery bypass surgery; clinically significant QT interval prolongation (QTc >=470ms in females, QTc >=450ms in males); (10) Patients with active infections, including active tuberculosis (clinical diagnosis includes clinical history, physical examination, and imaging findings, as well as TB testing conducted according to local medical practice), human immunodeficiency virus infection (HIV antibody positive), hepatitis B (known HBV surface antigen (HBsAg) positive and HBV DNA >= 10^3 copies/mL), hepatitis C (known HCV antibody positive and HCV-RNA >= 10^4 copies/mL); patients with hepatitis B and C whose conditions have been controlled by antiviral treatment can participate in this study; (11) The presence of any severe or uncontrollable systemic disease; (12) Patients with neurological or psychiatric disorders who are unable or unwilling to cooperate; (13) Female patients who are pregnant or breastfeeding; (14) Subjects who have received any other investigational drug treatment or participated in other clinical trials within 28 days; (15) Patients deemed unsuitable for inclusion by the researchers.

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

从 From 2026-03-31 00:00:00 至 To 2026-10-30 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	15
Group：	Experimental group	Sample size：	15
干预措施：	参考类器官药敏结果，综合临床经验和患者状况，选择治疗方案。	干预措施代码：
Intervention：	Based on the results of organoid drug sensitivity, combined with clinical experience and patient condition, select a treatment plan.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	重庆	市(区县)：
Country：	China	Province：	Chongqing	City：
单位(医院)：	陆军军医大学第二附属医院	单位级别：	三甲
Institution hospital：	Second Affiliated Hospital of Army Medical University	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：	Objective 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：	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：	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：	组织	组织：
Sample Name：	tissue	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：	胸水	组织：
Sample Name：	hydrothorax	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：	腹水	组织：
Sample Name：	ascites	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)：

N/A

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：	无
Blinding：	None
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	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）：	临床试验公共管理平台 IPD（http://www.medresman.org.cn）。文章发表后
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	ResMan IPD (http://www.medresman.org.cn) . After the article was published
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：	有/Yes
注册人： Name of Registration：	2026-03-25 09:06:42