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：	ChiCTR2500114779
最近更新日期： Date of Last Refreshed on：	2025-12-17 16:13:53
注册时间： Date of Registration：	2025-12-17 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	评估缬沙坦联合胸部放疗联合免疫检查点抑制剂对比胸部放疗联合免疫检查点抑制剂治疗后半年放射性肺炎发生率的一项随机、对照、开放性队列临床研究
Public title：	A randomized, controlled, open-label cohort clinical study to evaluate the incidence of radiation pneumonitis six months after treatment with valsartan combined with thoracic radiotherapy and immune checkpoint inhibitors versus thoracic radiotherapy and immune checkpoint inhibitors alone.
注册题目简写：
English Acronym：
研究课题的正式科学名称：	评估缬沙坦联合胸部放疗联合免疫检查点抑制剂对比胸部放疗联合免疫检查点抑制剂治疗后半年放射性肺炎发生率的一项随机、对照、开放性队列临床研究
Scientific title：	A randomized, controlled, open-label cohort clinical study to evaluate the incidence of radiation pneumonitis six months after treatment with valsartan combined with thoracic radiotherapy and immune checkpoint inhibitors versus thoracic radiotherapy and immune checkpoint inhibitors alone
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：	刘亚男	研究负责人：	孙美丽
Applicant：	yanan Liu	Study leader：	Meili Sun
申请注册联系人电话： Applicant telephone：	+86 178 0627 4023	研究负责人电话： Study leader's telephone：	+86 189 5311 6532
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：	537579513@qq.com	研究负责人电子邮件： Study leader's E-mail：	smli1980@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：	山东济南市解放路105号	研究负责人通讯地址：	山东济南市解放路105号
Applicant address：	No. 105, Jiefang Road, Jinan City, Shandong Province	Study leader's address：	No. 105, Jiefang Road, Jinan City, Shandong 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：	济南市中心医院
Applicant's institution：	Jinan central hospital
研究负责人所在单位：	济南市中心医院
Affiliation of the Leader：	Jinan central 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：	济科伦审(202541200)	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：	济南市中心医院科研伦理委员会
Name of the ethic committee：	Research Ethics Committee of Jinan Central Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2025-09-12 00:00:00
伦理委员会联系人：	潘柳竹
Contact Name of the ethic committee：	Liuzhu Pan
伦理委员会联系地址：	山东济南市解放路105号
Contact Address of the ethic committee：	No. 105, Jiefang Road, Jinan City, Shandong Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 531 5586 5622	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：

济南市中心医院

Primary sponsor：

Jinan central hospital

研究实施负责（组长）单位地址：

山东济南市解放路105号

Primary sponsor's address：

No. 105, Jiefang Road, Jinan City, Shandong 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)：	山东	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	济南市中心医院	具体地址：	山东济南市解放路105号
Institution hospital：	Jinan central hospitalJinan central hospital	Address：	No. 105, Jiefang Road, Jinan City, Shandong Province

经费或物资来源：

吴阶平医学基金会

Source(s) of funding：

Wu Jieping Medical Foundation

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：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

评估缬沙坦联合胸部放疗联合免疫检查点抑制剂治疗对照胸部放疗联合免疫检查点抑制剂治疗患者半年内2级及以上RP发生率。

Objectives of Study：

Evaluate the incidence of grade 2 or higher radiation pneumonitis (RP) within half a year in patients treated with valsartan combined with thoracic radiotherapy and immune checkpoint inhibitors versus those treated with thoracic radiotherapy and immune checkpoint inhibitors alone.

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 years old, gender not restricted.
2) Pathologically confirmed lung cancer, patients in advanced stage, locally advanced stage or those who cannot undergo surgery in the early stage.
3) ECOG physical activity score 0-2.
4) Expected survival time of more than half a year.
5) Adequate organ function: expected survival period > half a year.
6) Sufficient hematopoietic function, liver and kidney function: a. Neutrophil count >=  1.5 × 10^9/L; b. White blood cell count >=  3 × 10^9/L; c. Platelet count >=  80 × 10^9/L; d. Hemoglobin >=  90 g/L; e. Creatinine <=  1.5 × ULN; f. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) <=  2.5 × ULN (for liver metastasis <=  5 × ULN); h. Total bilirubin <=  1.5 × ULN (for liver metastasis <=  3 × ULN); i. Alkaline phosphatase <=  5 × ULN.
7) Plan to receive conventional fractionated thoracic radiotherapy (single irradiation dose 1.8 - 2.2 Gy), planned irradiation dose of more than 45 Gy.
8) Signed the informed consent form before the trial and fully understood the trial content, process and possible adverse reactions.
9) Able to complete the study as per the trial protocol.
10) Subjects (including male subjects) have taken effective contraceptive measures within 14 days before screening and are willing to have no pregnancy plan from the time of signing the informed consent until the end of the study and voluntarily take effective contraceptive measures.y (single irradiation dose 1.8 - 2.2 Gy), planned irradiation dose of more than 45 Gy.
8) Signed the informed consent form before the trial and fully understood the trial content, process and possible adverse reactions.
9) Able to complete the study as per the trial protocol.
10) Subjects (including male subjects) have taken effective contraceptive measures within 14 days before screening and are willing to have no pregnancy plan from the time of signing the informed consent until the end of the study and voluntarily take effective contraceptive measures.

排除标准：

1) 静息状态血压低于110/60mmHg患者 2) 无法口服吞咽药物，或存在经研究者判断严重影响胃肠道吸收的状况（如慢性腹泻、肠梗阻等）。 3) 患有严重肺功能障碍性疾病，如间质性疾病、重度慢性阻塞性肺疾病（COPD），存在胸部放疗禁忌 4) 有严重的心脑血管疾病史（血压控制稳定的高血压患者可入，但降压药物需包含缬沙坦） 5) 存在口服缬沙坦禁忌症，如肾动脉狭窄、重度肾功能损害等。 6) 研究者认为受试者存在任何临床或实验室检查异常或其他原因而不适合参加本临床研究 7) 既往曾行胸部放疗

Exclusion criteria：

1) Patients with resting blood pressure lower than 110/60 mmHg 2) Unable to take oral medications, or having conditions that, in the judgment of the investigators, severely affect gastrointestinal absorption (such as chronic diarrhea, intestinal obstruction, etc.). 3) Suffering from severe pulmonary dysfunction diseases, such as interstitial diseases, severe chronic obstructive pulmonary disease (COPD), and having contraindications for chest radiotherapy. 4) Having a history of severe cardiovascular or cerebrovascular diseases (patients with stable blood pressure control can participate, but the antihypertensive drugs must include valsartan). 5) Having contraindications for oral valsartan, such as renal artery stenosis, severe renal function impairment, etc. 6) The investigator believes that the subject has any clinical or laboratory examination abnormalities or other reasons that make them unsuitable to participate in this clinical study. 7) Has previously undergone chest radiotherapy

研究实施时间：

Study execute time：

从 From 2025-12-30 00:00:00至 To 2027-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-12-30 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：	缬沙坦联合胸部放疗联合免疫检查点抑制剂	样本量：	50
Group：	Valsartan combined with chest radiotherapy combined with immune checkpoint inhibitors	Sample size：	50
干预措施：	1.首次胸部放疗联合免疫开始口服缬沙坦 80mg qd，注意监测血压，周六日不停服，直至放疗结束后半年。 2.免疫检查点抑制剂治疗，每3周一次，使用剂量按照说明书推荐计剂量，使用药物包括并不限于信迪力单抗、欧狄沃单抗 3.在免疫治疗2周内开始接受转移灶或原发灶放射治疗，根据研究者决定可行常规分割或大分割放疗，要求2Gy分次放射等效剂量(EQD2)≥30Gy。	干预措施代码：
Intervention：	1. For the first round of chest radiotherapy combined with immunotherapy, start oral valsartan 80mg once daily. Pay attention to monitoring blood pressure. Do not stop taking it on weekends until half a year after the end of radiotherapy. 2. Immune checkpoint inhibitor treatment is administered every 3 weeks. The dosage is calculated according to the instructions. The drugs used include but are not limited to Xinteli antibody and Opdivo antibody. 3. Radiotherapy for metastatic or primary lesions should be started within 2 weeks of immunotherapy. Depending on the investigator's decision, conventional fractionated or hyperfractionated radiotherapy can be used. The required equivalent dose (EQD2) of 2Gy per fraction should be >= 30Gy.	Intervention code：

组别：	胸部放疗联合免疫检查点抑制剂	样本量：	50
Group：	Chest radiotherapy combined with immune checkpoint inhibitors	Sample size：	50
干预措施：	1.免疫检查点抑制剂治疗，每3周一次，使用剂量按照说明书推荐计剂量，使用药物包括并不限于信迪力单抗、欧狄沃单抗 2.在免疫治疗2周内开始接受转移灶或原发灶放射治疗，根据研究者决定可行常规分割或大分割放疗，要求2Gy分次放射等效剂量(EQD2)≥30Gy。	干预措施代码：
Intervention：	1. Immune checkpoint inhibitor treatment is administered every 3 weeks. The dosage is calculated according to the instructions. The drugs used include but are not limited to Xinteli antibody and Opdivo antibody. 2. Radiotherapy for metastatic or primary lesions should be started within 2 weeks of immunotherapy. Depending on the investigator's decision, conventional fractionated or hyperfractionated radiotherapy can be used. The required equivalent dose (EQD2) of 2Gy per fraction should be >= 30Gy.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	山东	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	济南市中心医院	单位级别：	三甲
Institution hospital：	Jinan central hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	总生存	指标类型：	主要指标
Outcome：	Overall 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：	无进展生存	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：	有效率	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：	安全性数据	指标类型：	副作用指标
Outcome：	Safety	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：	无	组织：
Sample Name：	None	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		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）：

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：	开放
Blinding：	Open label
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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	none
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：	（一）数据记录本项目采用表格记录。根据GCP要求，为保证病人隐私，不应出现病人姓名。患者姓名一律填姓名代码，代码用汉语拼音缩写。具体用药剂量和时间不明，应填写：“不明”；不得空项、漏项。研究者应保证所有数据必须与“住院病历”一致。（二）数据监察研究单位：在试验过程中，研究单位对完成的试验病例资料进行审核，检查资料是否完备，检查数据填写是否正确、完整、规范，考核全部数据的可溯源性。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	(I) Data Recording This project employs tabular recording. In accordance with the requirements of Good Clinical Practice (GCP), to ensure patient privacy, patient names should not be included. Instead, a name code using the pinyin abbreviation should be filled in. For specific drug doses and times that are unknown, the entry "unknown" should be filled in; no blanks or omissions are allowed. The investigator must ensure that all data are consistent with the "hospital medical records." (II) Data Monitoring Research Unit: During the trial, the research unit will review the completed case records to check for completeness of the data, correctness, completeness, and standardization of data entry, and to assess the traceability of all data.
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：	2025-12-17 16:13:48