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：	ChiCTR2600119639
最近更新日期： Date of Last Refreshed on：	2026-03-02 09:34:17
注册时间： Date of Registration：	2026-03-02 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	信迪利单抗联合含铂双药化疗±肠道低剂量照射一线治疗晚期非小细胞肺癌的开放标签、随机对照、Ⅱ期临床研究
Public title：	Open-label, randomized, phase II clinical study of camrelizumab combined with platinum-based doublet chemotherapy with or without low-dose intestinal irradiation as first-line treatment for advanced non-small cell lung cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	信迪利单抗联合含铂双药化疗±肠道低剂量照射一线治疗晚期非小细胞肺癌的开放标签、随机对照、Ⅱ期临床研究
Scientific title：	Open-label, randomized, phase II clinical study of camrelizumab combined with platinum-based doublet chemotherapy with or without low-dose intestinal irradiation as first-line treatment for advanced 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：	蔡国新	研究负责人：	孟雪
Applicant：	Cai GuoXin	Study leader：	Meng Xue
申请注册联系人电话： Applicant telephone：	+86 155 6248 1150	研究负责人电话： Study leader's telephone：	+86 188 6687 9080
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：	15562481150@163.com	研究负责人电子邮件： Study leader's E-mail：	mengxue5409@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：	⼭东省济南市槐荫区济充路440号	研究负责人通讯地址：	⼭东省济南市槐荫区济充路440号
Applicant address：	No. 440, Jichong Road, Huaiyin District, Jinan City, Shandong Provin	Study leader's address：	No. 440, Jichong Road, Huaiyin District, Jinan City, Shandong Provin
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：	⼭东第⼀医科⼤学附属肿瘤医院(⼭东省肿瘤医院)
Applicant's institution：	Cancer Hospital Affiliated to Shandong First Medical University (Shandong 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(⼭东省肿瘤医院)
Affiliation of the Leader：	Cancer Hospital Affiliated to Shandong First Medical University (Shandong Cancer 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：	SDZLEC2026-006-002	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：	2026-02-09 00:00:00
伦理委员会联系人：	宋现让
Contact Name of the ethic committee：	Xianrang Song
伦理委员会联系地址：	⼭东省济南市槐荫区济兖路440号⼭东省肿瘤医院
Contact Address of the ethic committee：	Shandong Cancer Hospital, No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 183 5336 9763	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：

山东第一医科大学附属肿瘤医院

Primary sponsor：

Cancer Hospital Affiliated of Shandong First Medical University

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, China

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 Province	City：
单位(医院)：	山东第一医科大学附属肿瘤医院	具体地址：	山东省济南市槐荫区济兖路440号
Institution hospital：	Cancer Hospital Affiliated of Shandong First Medical University	Address：	No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province, China

经费或物资来源：

给予患者入组补助，并报销肠道放疗费用，经费由吴阶平医学基金会科研专项资助基金提供

Source(s) of funding：

Provide enrollment stipends to patients and reimburse for intestinal radiotherapy costs. The funds are provided by the Wu Jieping Medical Foundation Research Special Funding.

研究疾病：

免疫耐药的晚期非小细胞肺癌

Target disease：

Immune-resistant advanced 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：

随机平行对照

Study design：

Parallel

研究目的：

旨在探索肠道低剂量照射联合信迪利单抗及含铂双药化疗在晚期 NSCLC 一线治疗中的疗效与安全性，以期为晚期 NSCLC 的一线治疗提供一种具有转化前景的创新治疗策略。

Objectives of Study：

Aim to explore the efficacy and safety of low-dose intestinal irradiation combined with camrelizumab and platinum-based doublet chemotherapy as first-line treatment in advanced NSCLC, with the goal of providing a novel, translationally promising therapeutic strategy for first-line treatment of advanced NSCLC.

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. Age >= 18 and <= 75 years, of any sex.
2. Subjects with advanced NSCLC confirmed by imaging and histopathology.
3. Negative results for EGFR, ALK, and ROS1 gene testing.
4. No prior anti-tumor therapy.
5. ECOG performance status (PS) score 0-1.
6. Expected overall survival > 3 months.
7. According to RECIST v1.1, at least one measurable target lesion must be evaluable by CT.
8. Patients with brain metastases that have been stabilized after repeated CT and/or MRI scans are eligible.
9. Patients have complete clinical and pathological information.
10. All screening laboratory tests must be performed within 14 days before treatment and meet the following criteria:
    Hematology (within 14 days before screening) without transfusion, without G-CSF, and without medications to correct values
    a. Hemoglobin (HB) >= 90 g/L
    b. Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
    c. Platelet count (PLT) >= 100 x 10^9/L
    d. White blood cell count (WBC) >= 4.0 x 10^9/L and <= 15 x 10^9/L
    Biochemistry (within 14 days before screening) without transfusion or albumin
    a. AST and ALT <= 1.5 x ULN (if there is liver metastasis, <= 5 x ULN)
    b. ALP <= 2.5 x ULN
    c. TBiL <= 1.5 x ULN
    d. Albumin (ALB) >= 30 g/L
    e. Creatinine (Cr) <= 1.5 x ULN, and creatinine clearance rate (CrCL) >= 60 mL/min (Cockcroft-Gault)
    f. APTT <= 1.5 x ULN, and INR or PT <= 1.5 x ULN (no anticoagulation)
11. Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to radiochemotherapy. Women of childbearing potential and male partners of women of childbearing potential must agree to use highly effective contraception during the study and for 180 days after the last administration of the study drug.
12. Voluntary participation in the clinical study and provision of written informed consent.

排除标准：

1.有放射治疗和免疫治疗禁忌症的患者。 2.伴有严重感染或伴有慢性腹泻。 3.怀孕或计划怀孕的患者。 4.参与可能影响本临床研究疗效/安全性的其他临床研究的患者。 5.在30天内接受过大型外科手术的患者。 6.入组前4周内接受过抗生素、抗真菌药物、抗病毒、抗寄生虫药物或益生菌治疗的患者。 7.脑膜转移（无论症状性还是非症状性）。 8.拟行腹盆部骨转移病灶放疗（肠道可能受到照射）的患者。 9.患有严重的肝病（如肝硬化）、肾脏疾病、呼吸系统疾病或无法控制的糖尿病、高血压等慢性系统疾病、不能耐受治疗的患者。 10.活动性、已知或怀疑自身免疫性疾病及自身免疫性疾病病史，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。 11.首剂用药前≤5年并发其他恶性肿瘤，除外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（允许非转移性前列腺癌或乳腺癌的激素治疗）。

Exclusion criteria：

1. Patients with contraindications to radiotherapy or immunotherapy. 2. Patients with severe infection or chronic diarrhea. 3. Pregnant patients or patients planning pregnancy. 4. Patients participating in other clinical studies that may affect the efficacy or safety of this study. 5. Patients who have undergone major surgery within 30 days prior to enrollment. 6. Patients who have received antibiotics, antifungals, antivirals, antiparasitics, or probiotic therapy within 4 weeks prior to enrollment. 7. Meningeal metastasis, symptomatic or asymptomatic. 8. Patients planned for radiotherapy of pelvic-abdominal bone metastases (areas may include the gastrointestinal tract). 9. Patients with severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, uncontrolled diabetes, hypertension, or other chronic systemic diseases who cannot tolerate therapy. 10. Active, known, or suspected autoimmune diseases and history of autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. Eligible: Type 1 diabetes mellitus (glycemic control achieved with insulin), residual hypothyroidism due to autoimmune thyroiditis treated with hormone replacement only, or conditions with no expected relapse in the absence of external triggers. Patients with eczema, psoriasis, chronic nonspecific lichen planus, or vitiligo without psoriatic arthritis may be enrolled if the rash covers less than 10% of body surface area, baseline disease is well controlled, only low-potency topical steroids are required, there has been no acute deterioration of the underlying condition in the past 12 months, and they do not require PUVA, methotrexate, retinoids, biologics, oral calcineurin inhibitors, high-potency or oral steroids. Enrollment requires meeting all these conditions. 11. Within 5 years prior to the first dose, a history of another malignancy, with exceptions for adequately treated cervical intraepithelial neoplasia, basal cell carcinoma or squamous cell skin cancer, locally treated prostate cancer after definitive therapy, or ductal carcinoma in situ (DCIS) after definitive therapy (hormonal therapy allowed for non-metastatic prostate or breast cancer).

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2027-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-03-15 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	化免组	样本量：	34
Group：	chemotherapy combined with immunotherapy group	Sample size：	34
干预措施：	化疗联合免疫	干预措施代码：
Intervention：	chemotherapy combined with immunotherapy	Intervention code：

组别：	化免联合肠道低剂量放疗组	样本量：	34
Group：	chemotherapy-immunotherapy combined with low-dose intestinal radiotherapy group	Sample size：	34
干预措施：	化免联合肠道低剂量放疗	干预措施代码：
Intervention：	chemotherapy-immunotherapy combined with low-dose intestinal radiotherapy	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 Province	City：
单位(医院)：	山东第一医科大学附属肿瘤医院	单位级别：	三甲
Institution hospital：	Cancer Hospital Affiliated of Shandong First Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	无进展生存期	指标类型：	主要指标
Outcome：	progression-free survival	Type：	Primary 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：	objective 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：	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	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：	相关不良事件	指标类型：	次要指标
Outcome：	adverse events	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：

标本中文名：	粪便	组织：
Sample Name：	feces	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）：

随机数字表法

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

Random Number Table Method

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	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）：	2027年12月31日；国家⽣物信息中⼼ China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	December 31, 2027 China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)
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：	病历记录表
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：	2026-03-02 09:34:12