ChiCTR2100054479 版本V1.0 版本创建时间2021/12/18 10:23:28 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：

 ChiCTR2100054479 

最近更新日期：

Date of Last Refreshed on：

 2021-12-18 10:20:06 

注册时间：

Date of Registration：

 2021-12-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

经支气管镜瘤体注射信迪利单抗后给与信迪利单抗联合含铂双药化疗一线治疗转移或复发非小细胞肺癌（NSCLC）的疗效和安全性的研究

Public title：

Study on the efficacy and safety of first-line treatment of metastatic or relapsed non-small cell lung cancer (NSCLC) with sindirib combined with platinum-containing dual-agent chemotherapy after intratumoral injection of sindirib through bronchoscope

注册题目简写：

English Acronym：

研究课题的正式科学名称：

经支气管镜瘤体注射信迪利单抗后给与信迪利单抗联合含铂双药化疗一线治疗转移或复发非小细胞肺癌（NSCLC）的疗效和安全性的研究

Scientific title：

Study on the efficacy and safety of first-line treatment of metastatic or relapsed non-small cell lung cancer (NSCLC) with sindirib combined with platinum-containing dual-agent chemotherapy after intratumoral injection of sindirib through bronchoscope

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：

姜媛媛 

研究负责人：

周昕 

Applicant：

Jiang Yuanyuan 

Study leader：

Zhou Xin 

申请注册联系人电话：

Applicant telephone：

 +86 15845676802

研究负责人电话：

Study leader's
telephone：

+86 13766550777

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：

 1162265600@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 fenghuangtaiyang@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：

齐齐哈尔市第一医院

研究负责人通讯地址：

齐齐哈尔市第一医院

Applicant address：

Qiqihar First Hospital

Study leader's address：

Qiqihar First Hospital

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：

齐齐哈尔市第一医院

Applicant's institution：

Qiqihar First Hospital

研究负责人所在单位：

Affiliation of the Leader：

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：

 ChiECRCT20210522

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：

中国注册临床试验伦理审查委员会

Name of the ethic committee：

China Registered Clinical Trial Ethics Review Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-11-26 00:00:00

伦理委员会联系人：

吴莼

Contact Name of the ethic committee：

Wu Chun

伦理委员会联系地址：

中国香港特别行政区九龙浸会大学道中国临床试验注册中心香港中心

Contact Address of the ethic committee：

Chinese Clinical trial Hong Kong Centre, Baptist University Road, Kowloon Tong, Hong Kong SAR, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 chictr001@chictr.org.cn

研究实施负责（组长）单位：

齐齐哈尔市第一医院

Primary sponsor：

Qiqihar First Hospital

研究实施负责（组长）单位地址：

齐齐哈尔市第一医院

Primary sponsor's address：

Qiqihar First Hospital

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

黑龙江

市(区县)：

齐齐哈尔

Country：

China

Province：

Heilongjiang

City：

Qiqihar

单位(医院)：

齐齐哈尔市第一医院

具体地址：

龙沙区公园路30号

Institution
hospital：

Qiqihar First Hospital

Address：

30 Gongyuan Road, Longsha District

经费或物资来源：

无

Source(s) of funding：

without

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：

 上市后药物 

Study phase：

4

研究设计：

单臂 

Study design：

Single arm 

研究目的：

主要目的： 评估经支气管镜瘤体注射信迪利单抗后给与信迪利单抗联合含铂双药化疗方案一线治疗驱动基因阴性的晚期NSCLC患者的客观缓解率（ORR）次要目的： ?根据RECIST V1.1评估受试者的无进展生存期（PFS）； ?根据RECIST V1.1评估受试者的疾病控制率（DCR）； ?根据RECIST V1.1评估受试者的缓解持续时间（DOR）； ?评估受试者总生存期（OS）； ?评估信迪利单抗联合含铂双药化疗的安全性和耐受性：包括不良事件（AE）和严重不良事件（SAE）的发生率，AE/SAE导致治疗终止的发生率 探索性目的： 探索支气管镜局部用药联合全身用药可行性探索潜在的能预测疗效的生物标志物，包括但不局限于肿瘤组织标本PD-L1表达水平、肿瘤突变负荷（Tumor Mutational Burden，TMB）等。  

Objectives of Study：

Main purpose: To evaluate the objective response rate (ORR) of advanced NSCLC patients with negative driver gene in first-line treatment after intratumoral injection of sindirizumab combined with platinum-containing dual-agent chemotherapy. Secondary purpose: The progression-free survival (PFS) of the subjects was evaluated according to RECIST V1.1; Evaluate the disease control rate (DCR) according to RECIST V1.1; Evaluate the duration of remission (dor) according to RECIST V1.1; Evaluate the overall survival time (OS) of the subjects; To evaluate the safety and tolerance of the combination chemotherapy of sindilumab and platinum-containing dual drugs, including the incidence of adverse events (AE) and serious adverse events (SAE), and the incidence of treatment termination caused by AE/SAE. Exploratory purpose: To explore the feasibility of local administration of bronchoscopy combined with systemic administration, and explore potential biomarkers that can predict the curative effect, including but not limited to the expression level of PD-L1 in tumor tissue samples, Tumor Mutational Burden (TMB), etc.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

合格入选本研究的受试者必须符合以下所有标准：
1.在实施任何试验相关流程之前，签署书面知情同意；
2.年龄≥18周岁且≤75周岁；
3.组织学或细胞学证实NSCLC，局部晚期ⅢB/ⅢC期、转移性或复发性IV期患者（国际肺癌研究协会和美国癌症分类联合委员会第8版TNM肺癌分期），且既往未接受过系统性治疗的受试者；支气管镜检查管腔内有可见实体肿瘤的患者
4.经组织学标本证实不适合接受靶向治疗（非鳞癌患者必须证实无EGFR基因敏感突变、ALK基因或ROS1基因融合变异）；
5.根据实体肿瘤疗效评价标准（RECIST 1.1版），至少有一处影像学可测量病灶。位于既往放疗照射野内的病灶如证实发生进展可视为可测量病灶；
6.既往未接受过针对晚期/转移性疾病的任何系统性抗肿瘤治疗。对于既往曾接受过含铂辅助/新辅助化疗，或针对进展期疾病接受过根治性放化疗的受试者，如疾病进展或复发与末次化疗药物治疗结束间隔至少6个月以上，允许入组本研究；
7.允许无症状或经局部治疗后症状稳定的脑转移受试者入组，只要受试者满足以下条件：
1)中枢神经系统之外有可测量病灶
2)无中枢神经系统症状或至少2周内症状无加重
3)无需糖皮质激素治疗，或首次给药前7天内停用糖皮质激素治疗，或首次给药前7天内糖皮质激素用量稳定且减至10mg/天泼尼松（或等效剂量）以下
8.允许受试者接受姑息性放射治疗（包括针对症状性脑转移的颅脑放疗），但放疗需在首次给药前至少1周结束，并且放疗相关的毒性恢复至小于或等于1度（CTCAE 5.0，脱发除外）。
9.ECOG评分0-1分；
10.预期生存时间>3个月；
11.足够器官功能，受试者需满足如下实验室指标：
1)近14天未使用粒细胞集落刺激因子的情况下，中性粒细胞绝对值（ANC）≥1.5x109/L；
2)近14天未输血的情况下，血小板≥100×109/L；
3)近14天内无输血或使用促红细胞生成素的情况下，血红蛋白>9g/dL；
4)总胆红素≤1.5倍正常值上限（ULN）
5)天门冬氨酸转氨酶（AST）、丙氨酸转氨酶（ALT）在≤2.5倍ULN（有肝转移的受试者允许ALT 或AST ≤5×ULN）；
6)血肌酐≤1.5倍ULN并且肌酐清除率（采用Cockcroft-Gault 公式计算）≥60 ml/min；
7)凝血功能良好，定义为国际标准化比值（INR）或凝血酶原时间（PT）≤1.5倍ULN；
8)甲状腺功能正常，定义为促甲状腺激素（TSH）在正常范围内。如基线TSH超出正常范围，如果总T3（或FT3）及FT4在正常范围内的受试者亦可入组；
9)心肌酶谱在正常范围内（如研究者综合判断为不具有临床意义的单纯实验室异常也允许入组）；
12.对于育龄期女性受试者，应在接受首次研究药物给药（第1周期第1天）之前的3天内接受尿液或血清妊娠试验且结果为阴性。如果尿液妊娠试验结果无法确认为阴性，则要求进行血液妊娠试验。非育龄期女性定义为绝经后至少１年，或进行过手术绝育或子宫切除术；
如存在受孕风险，所有受试者（不论男性或女性）均需在整个治疗期间直至治疗末次研究药物给药后120天（或末次研究药物给药后180天）内采用年失败率低于1%的避孕措施。

Inclusion criteria

Eligible subjects in this study must meet all the following criteria:
1. Sign the written informed consent before implementing any test-related procedures;
2. Age ≥18 years old and ≤75 years old;
3. Subjects with NSCLC confirmed by histology or cytology, locally advanced stage ⅢB/ⅢC, metastatic or recurrent stage IV (TNM stage of lung cancer, 8th edition of the International Association for the Research of Lung Cancer and the United States Joint Committee on Cancer Classification), who have not received systematic treatment in the past; Patients with visible solid tumors in the lumen of bronchoscopy
4. It is proved by histological specimens that it is not suitable for targeted therapy (non-squamous cell carcinoma patients must prove that there is no EGFR gene sensitive mutation, ALK gene or ROS1 gene fusion mutation);
5. According to the evaluation standard of curative effect of solid tumors (Recist version 1.1), at least one lesion can be measured by imaging. If the lesion located in the irradiation field of previous radiotherapy is confirmed to have progressed, it can be regarded as measurable lesion;
6. Never received any systematic anti-tumor treatment for advanced/metastatic diseases in the past. Subjects who have received platinum-containing adjuvant/neoadjuvant chemotherapy in the past, or who have received radical radiotherapy and chemotherapy for advanced diseases, if the interval between the progression or recurrence of the disease and the end of the last chemotherapy drug treatment is at least 6 months, are allowed to enter this study;
7. Allow asymptomatic or stable brain metastasis subjects after local treatment, as long as the subjects meet the following conditions:
1) There are measurable lesions outside the central nervous system
2) No symptoms of central nervous system or no aggravation of symptoms within at least 2 weeks.
3) No glucocorticoid treatment is needed, or glucocorticoid treatment is stopped within 7 days before the first administration, or the dosage of glucocorticoid is stable and reduced to less than 10mg/ day prednisone (or equivalent dose) within 7 days before the first administration.
8. Subjects are allowed to receive palliative radiotherapy (including cranial radiotherapy for symptomatic brain metastasis), but the radiotherapy should be finished at least one week before the first dose, and the toxicity related to radiotherapy should be restored to less than or equal to 1 degree (CTCAE 5.0, except alopecia).
9.ECOG score 0-1;
10. Expected survival time > 3 months;
1. Sufficient organ function, subjects need to meet the following laboratory indicators:
1) The absolute value of neutrophils (ANC) is ≥ 1.5x109/L without granulocyte colony stimulating factor in recent 14 days;
2) Platelets ≥ 100× 109/L without blood transfusion in recent 14 days;
3) hemoglobin > 9g/dl in the last 14 days without blood transfusion or using erythropoietin;
4) Total bilirubin ≤1.5 times the upper limit of normal value (ULN)
5) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are at ≤2.5 times ULN (ALT or AST ≤ 5× ULN is allowed for subjects with liver metastasis);
6) Serum creatinine ≤1.5 times ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) ≥ 60 ml/min;
7) Good coagulation function, defined as international standardized ratio (INR) or prothrombin time (PT)≤1.5 times ULN；;
8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) in the normal range. If the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled.
9) The myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judges that there is no clinical significance, the simple laboratory abnormality is also allowed to enter the group);
12. Female subjects of childbearing age should receive urine or serum pregnancy test with negative results within 3 days before receiving the first study drug administration (the first day of the first cycle). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing age women are defined as women who have been at least one year after menopause, or have undergone surgical sterilization or hysterectomy;
If there is a risk of pregnancy, all subjects (male or female) should take contraceptive measures with an annual failure rate of less than 1% during the whole treatment period up to 120 days after the last study drug administration (or 180 days after the last study drug

排除标准：

1.病理为小细胞肺癌（SCLC），包括SCLC与NSCLC混合的肺癌；
2.全身状态极度衰弱，不能耐受支气管镜检查者；
3.喉结核、有恶性病变颈椎转移或主动脉瘤患者；
4.对麻醉药物过敏，不能用其它药物代替者；
5.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
6.首次研究药物给药前接受过放射治疗，符合以下情况之一：
1)治疗前14天内曾有≥30%的骨髓接受过放射治疗
2)治疗前6周内接受过针对肺部病灶的放疗且剂量>30Gy（入组受试者必须从既往放疗的毒性中恢复至1级或以下，无需糖皮质激素治疗且无放射性肺炎病史）
3)姑息性放疗结束时间在首次研究药物给药前7天内；
7.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）；
8.当前正在参与干预性临床研究治疗，或在首次给药前4周内接受过其他研究药物或使用过研究器械治疗；
9.既往接受过下列疗法：抗PD-1、抗PD-L1或抗PD-L2药物或者针对另一种刺激或协同抑制T细胞受体（例如，CTLA-4、OX-40、CD137）的药物；
10.首次给药前2周内接受过具有抗肺癌适应症的中成药或免疫调节作用的药物（包括胸腺肽、干扰素、白介素，除外为控制胸水局部使用）系统性全身治疗；
11.首次给药前2年内发生过需要全身性治疗（例如使用缓解疾病药物、糖皮质激素或免疫抑制剂）的活动性自身性免疫疾病。替代疗法（例如甲状腺素、胰岛素或者用于肾上腺或垂体机能不全的生理性糖皮质激素等）不视为全身性治疗；
12.研究首次给药前7天内正在接受全身性糖皮质激素治疗（不包括喷鼻、吸入性或其他途径的局部糖皮质激素）或任何其他形式的免疫抑制疗法；
注：允许使用生理剂量的糖皮质激素（≤10 mg/天的泼尼松或等效药物）；
13.存在临床上不可控制的胸腔积液/腹腔积液（不需要引流积液或停止引流3天积液无明显增加的受试者可以入组）；
14.已知异体器官移植（角膜移植除外）或异体造血干细胞移植；
15.已知对本研究药物信迪利单抗、培美曲塞、吉西他滨、卡铂、顺铂等活性成分或辅料过敏者;
16.在开始治疗前，尚未从任何干预措施引起的毒性和/或并发症中充分恢复（即，≤1级或达到基线，不包括乏力或脱发）；
17.已知人类免疫缺陷病毒（HIV）感染史（即HIV 1/2抗体阳性）；
18.未经治疗的活动性乙肝（定义为HBsAg阳性同时检测到HBV-DNA拷贝数大于所在研究中心检验科正常值上限）；
注：符合下列标准的乙肝受试者亦可入组：
1)首次给药前HBV病毒载量<1000拷贝/ml（200 IU/ml），受试者应在整个研究化疗药物治疗期间接受抗HBV治疗避免病毒再激活
2)对于抗HBc（+）、HBsAg（-）、抗HBs（-）和HBV病毒载量（-）的受试者，不需要接受预防性抗HBV治疗，但是需要密切监测病毒再激活
19.活动性的HCV感染受试者（HCV抗体阳性且HCV-RNA水平高于检测下限）；
20.首次给药之前（第1周期，第1天）30天内接种过活疫苗；
注：允许首次给药前30天内接受针对季节性流感的注射用灭活病毒疫苗；但是不允许接受鼻内用药的减毒活流感疫苗。
21.妊娠或哺乳期妇女；
22.存在任何严重或不能控制的全身性疾病，例如：
1)静息心电图在节律、传导或形态上出现有重大且症状严重难以控制的异常，如完全性左束支传导阻滞，Ⅱ度以上心脏传导阻滞，室性心律失常或心房颤动；
2)不稳定型心绞痛，充血性心力衰竭，纽约心脏病协会（NYHA）分级≥ 2 级的慢性心衰；
3)入组前6个月内出现心肌梗死；
4)血压控制不理想（收缩压＞140 mmHg，舒张压＞90 mmHg）；
5)首次给药前1年内存在需要糖皮质激素治疗的非感染性肺炎病史，或当前存在临床活动性间质性肺病；有严重出血倾向及凝血机制障碍者
6)存在需要全身性治疗的活动性或未能控制的感染；
7)存在临床活动性憩室炎、腹腔脓肿、胃肠道梗阻；
8)肝脏疾病如肝硬化、失代偿性肝病、急性或慢性活动性肝炎；
9)糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L）；
10)尿常规提示尿蛋白≥++，且证实24小时尿蛋白定量＞1.0 g者；
11)存在精神障碍且无法配合治疗的受试者；
有可能干扰试验结果、妨碍受试者全程参与研究的病史或疾病证据、治疗或实验室检查值异常，或研究者认为其他不适合入组的情况研究者认为存在其他潜在风险不适合参加本研究。

Exclusion criteria：

1. The pathology is small cell lung cancer (SCLC), including lung cancer with mixed SCLC and NSCLC;
2. The whole body is extremely weak and cannot tolerate bronchoscopy;
3. Patients with laryngeal tuberculosis, cervical metastasis with malignant lesions or aortic aneurysm;
4. Those who are allergic to narcotic drugs and cannot be replaced by other drugs;
5. Respiratory tract has acute suppurative inflammation with high fever, acute asthma attack and hemoptysis.
6. The first study drug received radiotherapy before administration, which meets one of the following conditions:
1) Within 14 days before treatment, 30% or more of bone marrow had received radiotherapy.
2) Received radiotherapy for lung lesions within 6 weeks before treatment, and the dose was > 30Gy (the enrolled subjects must recover from the toxicity of previous radiotherapy to Grade 1 or below, without glucocorticoid treatment and no history of radiation pneumonia)
3) The end time of palliative radiotherapy is within 7 days before the first study drug administration;
7. Diagnosed as other malignant diseases other than NSCLC within 5 years before the first administration (excluding radical basal cell carcinoma of skin, squamous cell carcinoma of skin, and/or radical resection of carcinoma in situ);
8. Currently participating in interventional clinical research and treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration;
9. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);
10. Within 2 weeks before the first administration, he has received systematic systemic treatment with Chinese patent medicines with anti-lung cancer indications or drugs with immunomodulatory effects (including thymosin, interferon and interleukin, except for controlling local use of pleural effusion);
1. Active autoimmune diseases requiring systemic treatment (for example, using disease-relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Substitution therapy (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered as systemic therapy;
12. Being receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoid) or any other form of immunosuppressive therapy within 7 days before the first administration of the study;
Note: Physiological dose of glucocorticoid (≤10 mg/ day prednisone or equivalent drug) is allowed;
13. There is clinically uncontrollable pleural effusion/peritoneal effusion (subjects who do not need drainage of effusion or who stop drainage for 3 days and have no obvious increase in effusion can be enrolled);
14. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
15. Those who are known to be allergic to the active ingredients or excipients of the drugs in this study, such as cimetidine, pemetrexed, gemcitabine, carboplatin and cisplatin;
16. Before starting treatment, it has not fully recovered from the toxicity and/or complications caused by any intervention measures (i.e. ≤ Grade 1 or reaching the baseline, excluding fatigue or alopecia);
17. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
18. Untreated active hepatitis B (defined as HBsAg positive and the copy number of HBV-DNA detected at the same time is greater than the upper limit of normal value in the laboratory of the research center);
Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
1) HBV viral load before the first dose is less than 1000 copies /ml(200 IU/ml), and the subjects should receive anti-HBV treatment to avoid reactivation of the virus during the whole study chemotherapy treatment period.
2) For the subjects with anti-HBc(+), HBsAg(-), anti-HBs(-) and HBV viral load (-), it is not necessary to receive preventive anti-HBV treatment, but it is necessary to closely monitor virus reactivation.
19. Active HCV infected subjects (HCV antibody is positive and HCV-RNA level is higher than the detection limit);
20. Vaccinated with live vaccine within 30 days before the first administration (1st day of 1st cycle);
Note: It is allowed to receive the inactivated virus vaccine for injection against seasonal influenza within 30 days before the first dose; However, it is not allowed to accept live attenuated influenza vaccine for intranasal administration.
21. Pregnant or lactating women;
2. There are any serious or uncontrollable systemic diseases, such as:
1) There are significant and uncontrollable abnormalities in rhythm, conduction or morphology of resting electrocardiogram, such as complete left bundle branch block, second degree or above cardiac block, ventricular arrhythmia or atrial fibrillation;
2) Unstable angina pectoris, congestive heart failure, chronic heart failure with new york Heart Association (NYHA) grade ≥ 2;
3) Myocardial infarction occurred within 6 months before enrollment;
4) Poor blood pressure control (systolic blood pressure > 140mmhg, diastolic blood pressure > 90mmhg);
5) There is a history of non-infectious pneumonia requiring glucocorticoid treatment within one year before the first administration, or there is currently clinically active interstitial lung disease; Those with severe bleeding tendency and dysfunction of coagulation mechanism
6) There are active or uncontrolled infections that need systemic treatment;
7) There are clinically active diverticulitis, abdominal abscess and gastrointestinal obstruction;
8) Liver diseases such as cirrhosis, decompensated liver diseases, acute or chronic active hepatitis;
9) Poor control of diabetes (FBG > 10 mmol/L);
10) Urine routine indicates that urine protein is ≥++,and it is confirmed that the 24-hour urine protein quantity is > 1.0g;
1) Subjects with mental disorders and unable to cooperate with treatment;
Medical history or disease evidence that may interfere with the test results, hinder the participants from participating in the whole study, abnormal treatment or laboratory examination values, or other conditions that researchers think are not suitable for the study, and researchers think that there are other potential risks that are not suitable for the study.

研究实施时间：

Study execute time：

从 From 2021-11-01 00:00:00至 To 2023-11-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-11-01 00:00:00 至 To 2022-04-30 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 30

Group：

Experimental group

Sample size：

干预措施：

信迪利单抗联合含铂双药化疗

干预措施代码：

Intervention：

Sintilimab combined with platinum-based doublet chemotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 黑龙江 

市(区县)：

 齐齐哈尔 

Country：

China

Province：

Heilongjiang

City：

Qiqihar

单位(医院)：

 齐齐哈尔市第一医院 

单位级别：

 三级甲等 

Institution
hospital：

Qiqihar First Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

肿瘤标志物

指标类型：

主要指标

Outcome：

Tumor markers

Type：

Primary 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：

肿瘤

组织：

Sample Name：

tumor

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 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）：

由周昕主任团队用支气管镜技术局部注射信迪利单抗的方法

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

The method of local injection of xindilimab with bronchoscopy by director Zhou Xin's team

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）：

Calculated Results after
the Study Completed(upload file)：

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）：

公开原始数据的日期2022年12月，方式是ResMan

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The original data was released in December 2022 by ResMan

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：

ResMan

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

ResMan

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-12-18 10:20:06