ChiCTR2300078276 版本V1.1 版本创建时间2024/07/28 10:56:10 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：

 ChiCTR2300078276 

最近更新日期：

Date of Last Refreshed on：

 2023-12-04 08:55:49 

注册时间：

Date of Registration：

 2023-12-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

放疗提高化疗联合免疫在晚期非小细胞肺癌患者疗效的临床研究

Public title：

Clinical study of radiotherapy to improve the efficacy of chemotherapy combined with immunity in patients with 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：

放疗提高化疗联合免疫在晚期非小细胞肺癌患者疗效的临床研究

Scientific title：

Clinical study of radiotherapy to improve the efficacy of chemotherapy combined with immunity in patients with 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：

宫晓梅 

研究负责人：

宫晓梅 

Applicant：

Xiaomei Gong 

Study leader：

Xiaomei Gong 

申请注册联系人电话：

Applicant telephone：

 +86 139 1625 9716

研究负责人电话：

Study leader's
telephone：

+86 139 1625 9716

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：

 gongxiaomei1981@163.com

研究负责人电子邮件：

Study leader's E-mail：

 gongxiaomei1981@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：

上海市杨浦区政民路507号

研究负责人通讯地址：

上海市杨浦区政民路507号

Applicant address：

No. 507,Zhengmin Road, Yangpu District, Shanghai

Study leader's address：

No. 507,Zhengmin Road, Yangpu District, Shanghai

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：

同济大学附属上海市肺科医院

Applicant's institution：

Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China

研究负责人所在单位：

同济大学附属上海市肺科医院

Affiliation of the Leader：

Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China

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：

 L23-210-2

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：

上海市肺科医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Pulmonary Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-10-27 00:00:00

伦理委员会联系人：

陈昶

Contact Name of the ethic committee：

Cheng Chang

伦理委员会联系地址：

上海市杨浦区政民路507号

Contact Address of the ethic committee：

No. 507,Zhengmin Road, Yangpu District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 6511 5006

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：

同济大学附属上海市肺科医院

Primary sponsor：

Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China

研究实施负责（组长）单位地址：

上海市杨浦区政民路507号

Primary sponsor's address：

No. 507,Zhengmin Road, Yangpu District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

People's Republic of China

Province：

Shanghai

City：

单位(医院)：

同济大学附属上海市肺科医院

具体地址：

上海市杨浦区政民路507号

Institution
hospital：

Shanghai Pulmonary Hospital, Tongji University School of Medicine

Address：

No. 507,Zhengmin Road, Yangpu District, Shanghai

经费或物资来源：

自筹

Source(s) of funding：

self-financing

研究疾病：

晚期非小细胞肺癌  

Target disease：

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：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

通过前瞻性研究探索放疗提高化疗联合免疫在晚期非小细胞肺癌患者中的疗效，通过研究初步探索放疗在晚期非小细胞肺癌综合治疗中的最佳介入时机。  

Objectives of Study：

Prospective studies were conducted to explore the effect of radiotherapy on chemotherapy combined with immunity in patients with advanced non-small cell lung cancer, and the best interventional timing of radiotherapy in the combined treatment of advanced non-small cell lung cancer was preliminarily explored.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

⑴病理确诊为非小细胞肺癌；无EGFR/ALK基因突变；PD-L1 TPS表达情况不受限（低于1%的患者不超过总样本量20%）； ⑵临床分期IV期（TNM分期系统），寡转移（转移病灶少于5个）患者（可包含不超过总样本量10%的无症状或治疗后稳定的脑转移）； ⑶既往未经肺癌治疗的患者； ⑷受试者签署知情同意书当天年龄≥18周岁且<75周岁，男女不限； ⑸受试者能够理解知情同意书，自愿参与并签署知情同意书； ⑹至少1处可测量病灶（根据实体肿瘤疗效评价标准RECIST V1.1）； ⑺体能状况评分0或1分（美国东部肿瘤协作组ECOG评分系统）； ⑻预期寿命至少6个月； ⑼具有足够的器官功能： a.骨髓功能：血红蛋白≥100 g/L（血红蛋白检查前28天内未接受输血），中性粒细胞绝对计数 ≥1.5×10^9/L，血小板计数≥100×10^9/L（血小板计数检查前14天内未接受输注单采血小板或者IL-11治疗）； b.凝血功能：国际标准化比率 (INR) 或凝血酶原时间 (PT) ＜1.5×正常上限（ULN），活化部分凝血活酶时间（APTT）≤1.5×ULN； c.肝功能：转氨酶（ALT和AST）≤2.5×ULN；总胆红素≤1.5×ULN（Gilbert's综合征或肝转移受试者总胆红素≤2.5×ULN）； d.肾功能：血清肌酐清除率≥60 mL/min（根据Cockcroft-Gault公式计算）； ⑽具有生育能力的女性受试者在首次给药前7天内，血清妊娠试验必须为阴性； ⑾具有生育能力的女性受试者或伴侣有生育能力的男性受试者同意从首次给药前7天开始采用高效避孕措施（年失败率低于1%）直至全部治疗结束后24周。

Inclusion criteria

(1) Non-small cell lung cancer, confirmed by pathology; No EGFR/ALK gene mutation;PD-L1 TPS expression was not limited (less than 1% of patients did not exceed 20% of the total sample size); (2) Patients with stage IV clinical staging (TNM staging system) and oligometastases (less than 5 metastatic lesions) (which can contain no more than 10% of the total sample size of asymptomatic or stable brain metastases after treatment); ⑶ Patients who have not been treated for lung cancer before; (4) Patients between 18 and 75 years old, male and female; (5) Patients can understand the informed consent, participate in and sign the informed consent voluntarily as well; ⑹ At least 1 measurable lesion (according to RECIST V1.1 for solid tumor efficacy evaluation); ⑺ Performance score of 0 or 1 (the Eastern Oncology Consortium ECOG scoring system); ⑻ Life expectancy of at least six months; (9) Have sufficient functions to the organs: a. Bone marrow function: hemoglobin ≥100 g/L (did not receive blood transfusion within 28 days before hemoglobin test), neutrophil absolute count ≥1.5×10^9/L, platelet count ≥100×10^9/L (did not receive platelet transfusion or IL-11 treatment within 14 days before platelet count test); b. Coagulation function: International Standardized ratio (INR) or prothrombin time (PT) < 1.5× upper normal limit (ULN), activated partial thrombin time (APTT) < 1.5×ULN; c. Liver function: transaminase (ALT and AST) ≤2.5×ULN; Total bilirubin ≤1.5×ULN (total bilirubin ≤2.5×ULN in subjects with Gilbert's syndrome or liver metastasis); d. Renal function: serum creatinine clearance ≥60 mL/min (calculated by Cockcroft-Gault formula); (10) In fertile female patients, serum pregnancy tests must be negative for seven days before first administration. (11) Fertile female patients or male patients whose partners are fertile agree to use effective birth control (with an annual failure rate of less than 1%) starting 7 days before the first dose until 24 weeks after the end of all treatment.

排除标准：

⑴本试验给药前28天内接受过重大手术治疗（如经腹、经胸等重大手术；不包括诊断性穿刺或外周血管通路置换术）或者未从手术治疗中恢复的受试者； ⑵本研究首次给药前14天内需要连续7天接受系统性皮质激素（≥10 mg/天，强的松，或等当量的其他皮质激素）或免疫抑制剂治疗；除外吸入或局部应用激素，或因肾上腺功能不全而接受生理替代剂量的激素治疗；允许短期（＜7天）皮质类固醇用于预防（例如，造影剂过敏）或治疗非自身免疫病症（例如，由接触过敏原引起的迟发型超敏反应）； ⑶本研究给药前28天内接受过活疫苗（包括减毒活疫苗）接种； ⑷既往或目前患有需要系统性激素治疗的间质性肺炎/肺病； ⑸既往或目前患有自身免疫性疾病，包括但不限于Crohn’s病、溃疡性结肠炎、系统性红斑狼疮、结节病、Wegener综合征（多血管炎的肉芽肿病、Graves病、类风湿关节炎、下垂体炎、眼色素层炎）、自身免疫性肝炎、系统性硬化病（硬皮病等）、桥本氏甲状腺炎、自身免疫性血管炎、 自身免疫性神经病变（Guillain-Barre综合征）等。除外下列情况：I型糖尿病、激素替代治疗稳定的甲状腺功能减退症（包括自身免疫性甲状腺病导致的甲状腺功能减退症）、不需要全身治疗的银屑病或白癜风； ⑹首次给药前5年内合并其他恶性肿瘤，除外已治愈的皮肤鳞癌、基底细胞癌、非肌层浸润性膀胱癌、局限性低危前列腺（定义为阶段≤T2a、格里森评分≤6分）和前列腺癌诊断时PSA≤10ng/mL（如测量，患者接受过根治性治疗且无PSA生化复发者可参与本研究）、原位宫颈/乳腺癌； ⑺患有未经控制的心脏、肾脏、胃肠道及感染性疾病等合并症； ⑻既往异基因骨髓或器官移植病史； ⑼既往对药物明显过敏（例如严重过敏反应、免疫介导的肝毒性、免疫介导的血小板减少症或贫血）； ⑽怀孕和/或哺乳期女性； ⑾活动性肺结核； ⑿其他会影响本研究药物治疗安全性或依从性的情况，包括但不限于精神类疾病、未控制的大量浆膜腔积液或需要反复引流（在干预后2周内复发）的中到大量浆膜腔积液的受试者、恶液质等； ⒀存在禁忌使用研究药物、可能会影响结果判读或治疗并发症可能给患者带来高风险的任何其他疾病、代谢功能紊乱、体格检查异常、或临床实验室异常。

Exclusion criteria：

(1) Major surgery (such as abdominal, thoracic and other major surgery) was received within 28 days before administration; Excluding diagnostic puncture or peripheral vascular access replacement) or patients who have not recovered from surgical treatment; (2) Systemic corticosteroids (≥10 mg/ day, prednisone, or equivalent corticosteroids) or immunosuppressant therapy were required for 7 consecutive days within 14 days prior to the first administration of this study; Except inhaled or topical use of hormones, or physiological replacement dose of hormone therapy for adrenal insufficiency; Allow short-term (< 7 days) corticosteroids for the prevention (e.g., contrast media allergy) or the treatment of non-autoimmune conditions (e.g., delayed hypersensitivity caused by exposure to allergens); (3) Received live vaccine (including attenuated live vaccine) within 28 days prior to administration in this study; (4) Past or current history of interstitial lung disease requiring systemic hormonal therapy; (5) Have or currently have an autoimmune disease, Including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome (granulomatous disease with multiple vasculitis, Graves' disease, rheumatoid arthritis, hypophysitis, ophthalmochromatitis), autoimmune hepatitis, systemic scleroderma (scleroderma, etc.), Hashimoto's thyroiditis, autoimmune vasculitis, Autoimmune neuropathy (Guillain-Barre syndrome), etc. The following conditions are excluded: Type I diabetes, hypothyroidism stable with hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo that do not require systemic therapy; ⑹ Other malignancies within 5 years prior to initial administration, except cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-muscular invasive bladder carcinoma, localized low-risk prostate (defined as stage ≤T2a, Gleason score ≤6), and PSA≤10ng/mL at the time of diagnosis of prostate cancer (as measured, Patients who had received radical treatment without PSA biochemical recurrence could participate in this study), cervical/breast cancer in situ; He has uncontrolled complications of heart, kidney, gastrointestinal and infectious diseases. ⑻ History of allogeneic bone marrow or organ transplantation; (9) dramatic reactions to drugs (such as severe allergic reactions, immunomediated hepatotoxicity, immunomediated thrombocytopenia, anemia); (10) Pregnant and/or lactating women; (11)Active tuberculosis; (12) Any other conditions that will affect the safety or compliance of treatment in the study, including but not limited to mental illness, uncontrolled large amounts of serous effusion, or medium to large amounts of serous effusion requiring repeated drainage (recurrence within 2 weeks after intervention), and acidosis; (13) The presence of contraindications in the use of the study drug, any other diseases, metabolic disorders, abnormalities in physical examination, or clinical laboratory abnormalities that might affect the interpretation of the results or the treatment complications that might place the patient at high risk.

研究实施时间：

Study execute time：

从 From 2023-12-01 00:00:00至 To 2026-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-12-04 00:00:00 至 To 2024-11-30 00:00:00

干预措施：

Interventions：

组别：

A组

样本量：

 60

Group：

Group A

Sample size：

干预措施：

6个周期免疫治疗联合化疗，序贯1个周期姑息性放疗。或者，2个周期免疫治疗联合化疗，序贯1个周期姑息性放疗，再序贯4个周期免疫治疗联合化疗

干预措施代码：

Intervention：

6 cycles of immunotherapy combined with chemotherapy, followed by 1 cycle of palliative radiotherapy. Alternatively, 2 cycles of immunotherapy combined with chemotherapy, followed by 1 cycle of palliative radiotherapy, and then followed by 4 cycles of immunotherapy combined with chemotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

People's Republic of China

Province：

Shanghai

City：

单位(医院)：

 同济大学附属上海市肺科医院 

单位级别：

 三甲 

Institution
hospital：

Shanghai Pulmonary Hospital, Tongji University School of Medicine

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：

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：

新发转移灶出现时间

指标类型：

次要指标

Outcome：

Time To New Metastasis

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：

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 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)：

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：

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：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-12-04 08:55:13