ChiCTR2400092211 版本V1.0 版本创建时间2024/11/12 14:56:53 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：

 ChiCTR2400092211 

最近更新日期：

Date of Last Refreshed on：

 2024-11-12 14:56:48 

注册时间：

Date of Registration：

 2024-11-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

化疗序贯QL1706辅助治疗可切除非小细胞肺癌的前瞻性、多中心、单臂、Ⅱ期临床研究

Public title：

A prospective, multicenter, single-arm, phase II clinical study of chemotherapy sequential QL1706 adjuvant therapy for resectable non-small cell lung cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

化疗序贯QL1706辅助治疗可切除非小细胞肺癌的前瞻性、多中心、单臂、Ⅱ期临床研究

Scientific title：

A prospective, multicenter, single-arm, phase II clinical study of chemotherapy sequential QL1706 adjuvant therapy for resectable 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：

章健 

研究负责人：

张晓东 

Applicant：

Jian Zhang 

Study leader：

Xiaodong Zhang 

申请注册联系人电话：

Applicant telephone：

 +86 130 9545 7871

研究负责人电话：

Study leader's
telephone：

+86 150 5124 3672

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：

 919939410@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 419317110@qq.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：

江苏省徐州市云龙区万达广场写字楼A座12楼

研究负责人通讯地址：

江苏省南通市通州区通扬北路30号

Applicant address：

12/F, Block A, Wanda Plaza Office Building, Yunlong District, Xuzhou City, Jiangsu Province, China

Study leader's address：

No. 30, Tongyang North Road, Tongzhou District, Nantong City, Jiangsu Province, China

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：

齐鲁制药有限公司

Applicant's institution：

Qilu Pharmaceutical Co., Ltd.

研究负责人所在单位：

南通市肿瘤医院

Affiliation of the Leader：

Nantong 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：

 通肿伦审(科研)2024-089

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：

南通市肿瘤医院科研伦理委员会

Name of the ethic committee：

Research Ethics Committee of Nantong Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-10-22 00:00:00

伦理委员会联系人：

南通市肿瘤医院科研伦理委员会

Contact Name of the ethic committee：

Research Ethics Committee of Nantong Cancer Hospital

伦理委员会联系地址：

江苏省南通市通州区通扬北路30号

Contact Address of the ethic committee：

No. 30, Tongyang North Road, Tongzhou District, Nantong City, Jiangsu Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 513 8671 2189

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：

南通市肿瘤医院

Primary sponsor：

Nantong Cancer Hospital

研究实施负责（组长）单位地址：

江苏省南通市通州区通扬北路30号

Primary sponsor's address：

No. 30, Tongyang North Road, Tongzhou District, Nantong City, Jiangsu 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)：

江苏

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

南通市肿瘤医院

具体地址：

江苏省南通市通州区通扬北路30号

Institution
hospital：

Nantong Cancer Hospital

Address：

No. 30, Tongyang North Road, Tongzhou District, Nantong City, Jiangsu Province, China

经费或物资来源：

自筹

Source(s) of funding：

self-finance

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：

 II期临床试验 

Study phase：

2

研究设计：

单臂 

Study design：

Single arm 

研究目的：

评价化疗序贯QL1706辅助治疗可切除非小细胞肺癌的有效性和安全性。  

Objectives of Study：

To evaluate the efficacy and safety of chemotherapy sequential QL1706 adjuvant therapy for resectable non-small cell lung cancer.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄≥18岁，男女均可； 2.组织学或细胞学证实的IB期（肿瘤≥ 4 cm）- IIIA期（T2-3N0、T1-3N1、T1-3N2）NSCLC（AJCC第八版）； 3.受试者者必须在入组前6-12周（≥ 42天和≤ 84天）完成NSCLC完全切除术，且必须从手术中充分恢复。接受的切除类型包括以下任何一种：肺叶切除术、袖状肺叶切除术、双叶切除术或肺切除术。不允许分段切除或楔形切除。 4.受试者需要进行完整的纵隔淋巴结清扫（MLND）。如果术前没有进行纵隔镜检查，则至少需要进行纵隔淋巴结系统取样。系统取样的定义是在指定层次至少切除一个有代表性的淋巴结。MLND需要切除这些相同层面的所有淋巴结。右侧开胸手术需要在第4和第7区进行取样或MLND，左侧开胸手术需要在第5和/或第6和第7区进行取样或MLND。如果外科医生在手术报告或单独提交的附录中明确记录对所需淋巴结区域进行了探查，则可作为例外情况处理；如果在这些区域未发现淋巴结，则认为参试者符合条件；如果参试者在某一层面有N2病变记录，则无需对所有层面进行取样；如果术前分期成像结果（对比计算机断层扫描[CT]和正电子发射断层扫描[PET]）未显示纵隔内有疾病的证据，则根据外科医生的决定不进行N2结节取样，参试者将被视为符合条件。 5.受试者可接受顺铂/卡铂+长春瑞滨/紫杉醇/多西他赛/培美曲塞（非鳞癌）/吉西他滨的化疗方案 6.预期寿命超过3个月； 7.ECOG体能状况评分0~1分； 8.育龄妇女必须在首次用药前7天内进行血清妊娠研究，且结果为阴性。育龄妇女受试者和伴侣为育龄妇女的男性受试者必须同意自签署知情同意书至末次给予研究药物后24周内避孕； 9.化疗前，实验室检查值满足以下条件： （1）血常规（筛查前14天内未输血、未使用造血刺激因子类药物纠正）：白细胞计数（white blood cell, WBC）≥ 3.0 × 109/L；绝对中性粒细胞计数（absolute neutrophil count, ANC）≥ 1.5 × 109/L；血小板（platelet, PLT）≥ 100 × 109/L；血红蛋白含量（hemoglobin, HGB）≥ 9.0 g/dL； （2）肝功能：无肝转移受试者天门冬氨酸氨基转移酶（aspartate transferase, AST）≤ 2.5 x ULN；丙氨酸肝氨基转移酶（alanine aminotransferase, ALT）≤ 2.5 x ULN，肝转移受试者其ALT、AST ≤ 5 x ULN；血清总胆红素（total bilirubin, TBIL）≤ 1.5 x ULN（除外Gilbert综合征总胆红素≤ 3.0 mg/dL）；（3）肾功能：血清肌酐≤ 1.5 x ULN或肌酐清除率（creatinine clearance rate, CrCl） ≥ 50 mL/minute；（4）凝血功能：国际标准化比率（international normalized ratio, INR）≤ 1.5 x ULN，活化部分凝血活酶时间（activated partial thromboplastin time, APTT）≤ 1.5 x ULN（仅适用于目前没有接受抗凝治疗的患者，对于目前正在接受抗凝治疗的患者应接受稳定剂量的抗凝剂治疗）； （5）其他：脂肪酶≤ 1.5 x ULN（若脂肪酶> 1.5 x ULN无临床或影像学证实胰腺炎的情况可以入组）；淀粉酶 ≤ 1.5 x ULN（若淀粉酶> 1.5 x ULN无临床或影像学证实胰腺炎的情况可以入组）；碱性磷酸酶（alkaline phosphatase, ALP）≤ 2.5 x ULN，肝转移或骨转移受试者，ALP ≤ 5 x ULN； 10.受试者自愿加入本研究，签署知情同意书，依从性好，配合随访。

Inclusion criteria

1. Age ≥ 18 years old, both male and female; 2. histologically or cytologically confirmed stage IB (tumor ≥ 4 cm) - stage IIIA (T2-3N0, T1-3N1, T1-3N2) NSCLC (AJCC 8th edition); 3. subject persons must have completed complete resection of NSCLC 6-12 weeks (≥ 42 days and ≤ 84 days) prior to enrollment and must have recovered adequately from the procedure. The type of resection accepted includes any of the following: lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy. Segmental resections or wedge resections are not permitted. 4.Subjects will be required to undergo complete mediastinal lymph node dissection (MLND). If mediastinoscopy is not performed preoperatively, systematic sampling of the mediastinal lymph nodes is required at a minimum. Systematic sampling is defined as the removal of at least one representative lymph node at specified levels.MLND requires the removal of all lymph nodes at these same levels. Sampling or MLND was required in zones 4 and 7 for right-sided open-heart surgery and in zones 5 and/or 6 and 7 for left-sided open-heart surgery.An exception was made if the surgeon clearly documented in the operative report or in a separately submitted appendix that the required lymph node areas were explored; if no lymph nodes were found in these areas, the participant was considered eligible; If the participant has a documented N2 lesion at one level, all levels need not be sampled; if the preoperative staging imaging results (contrast computed tomography [CT] and positron emission tomography [PET] scans) do not show evidence of disease in the mediastinum, N2 node sampling will not be performed at the discretion of the surgeon, and the participant will be considered eligible. 5. Subjects can receive a chemotherapy regimen of cisplatin/carboplatin + vincristine/paclitaxel/docetaxel/pemetrexed (non-squamous)/gemcitabine 6. Life expectancy is more than 3 months; 7. ECOG physical status score of 0 to 1; 8. women of childbearing potential must have a negative serum pregnancy study within 7 days prior to first dose. Female subjects of childbearing potential and male subjects whose partner is a woman of childbearing potential must agree to contraception from the time of signing the informed consent until 24 weeks after the last administration of study drug; 9. Prior to chemotherapy, the laboratory test values meet the following conditions: (1) blood routine (no blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days before screening): white blood cell (WBC) ≥ 3.0 × 109/L; absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelet (PLT) ≥ 100 × 109/L; hemoglobin (HGB) ≥ 9.0 g/dL; and the hemoglobin level (HGB) ≥ 1.0 g/dL. 1.5 × 109/L; platelet (PLT) ≥ 100 × 109/L; hemoglobin (HGB) ≥ 9.0 g/dL; (2) Liver function: aspartate transferase (AST) ≤ 2.5 x ULN in subjects without liver metastases; alanine aminotransferase (ALT) ≤ 2.5 x ULN, ALT, AST ≤ 5 x ULN in subjects with liver metastases; serum total bilirubin (TBIL) ≤ 1.5 x ULN (except for Gilbert's syndrome, where total bilirubin is ≤ 3.0 mg/dL). (3) Renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance rate (CrCl) ≥ 50 mL/minute; (4) Coagulation function: international normalized ratio (INR) ≤ 1.5 x ULN, activation of the blood clotting function (CCT) ≤ 1.5 x ULN. (4) Coagulation function: international normalized ratio (INR) ≤ 1.5 x ULN, activated partial thromboplastin time (APTT) ≤ 1.5 x ULN (only for patients who are not currently receiving anticoagulation therapy; patients who are currently receiving anticoagulation therapy should receive a stable dose of anticoagulants); (5) Others: lipase ≤ 1.5 x ULN (if lipase > 1.5 x ULN without clinical evidence) 1.5 x ULN without clinical or imaging confirmation of pancreatitis may be enrolled); amylase ≤ 1.5 x ULN (if amylase > 1.5 x ULN without clinical or imaging confirmation of pancreatitis may be enrolled); alkaline phosphatase (ALP) ≤ 2.5 x ULN, and in subjects with liver metastases or bone metastases, ALP ≤ 5 x ULN; 10. Subjects will voluntarily enroll in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.

排除标准：

1. 孕妇和哺乳期妇女； 2. 既往进行过全身化疗； 3. 入组前5年内曾接受过激素类癌症治疗或放射治疗（入组前5年以上曾因恶性肿瘤接受过手术、生物治疗、激素治疗或放射治疗，但目前已被认为治愈者可接受。允许目前使用激素替代疗法或口服避孕药。）； 4. 听力障碍患者； 5. 已知对患者将接受的化疗方案中的任何成分或甘露醇过敏； 6. 间质性肺病或有肺炎病史； 7. 入组前5年内发生过NSCLC以外的恶性肿瘤，但转移或死亡风险微乎其微（如预期5年生存率大于90%）且经治疗达到预期治愈效果者除外（如经充分治疗的宫颈原位癌、基底细胞或鳞状细胞皮肤癌、经手术治疗达到治愈目的的局部前列腺癌、经手术治疗达到治愈目的的导管原位癌）。 8. 活动性、已知或怀疑自身免疫性疾病，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； 9. 既往接受过任何T细胞共刺激或免疫检查点治疗，包括但不限于细胞毒性T淋巴细胞相关抗原-4（cytotoxic T lymphocyte-associated antigen-4，CTLA-4）抑制剂、PD-1抑制剂、PD-L1/2抑制剂或其他靶向T细胞的药物； 10. HBsAg阳性且HBV DNA拷贝数大于所在研究中心检验科正常值上限（1000拷贝数/ml或500 IU/ml），或HCV阳性（HCV RNA或HCV Ab检测提示急慢性感染）；已知HIV阳性病史或已知的获得性免疫缺陷综合征（Acquired Immune Deficiency Syndrome, AIDS）； 11. 患有特发性肺纤维化病史、机化性肺炎（如闭塞性细支气管炎）、药物诱导的肺炎、需要类固醇治疗的放射性肺炎或有临床症状的活动性肺炎；或其他严重影响肺功能的中重度肺部疾病（放射区存在放射性肺炎（纤维化）病史的患者可参加本研究）； 12. 活动性肺结核（tuberculosis, TB）或筛选前≤ 48周内有活动性肺结核感染病史的受试者，无论是否治疗； 13. 存在重度感染，包括但不仅限于需住院治疗的感染并发症、菌血症、重症肺炎等； 14. 有严重的心血管疾病，如纽约心脏病协会（New York Heart Association, NYHA）2级以上心力衰竭、不稳定型心绞痛、不稳定性心律失常、随机前3个月内发生的心肌梗死或脑血管意外； 15. 既往接受过同种异体骨髓移植或实体器官移植的患者； 16. 已知对研究药物或辅料过敏，已知对任何一种单抗发生严重过敏反应； 17. 签署ICF前4周内曾接受其它任何试验药物治疗或参加过另一项干预性临床研究； 18. 首剂研究药物前≤ 14天内使用皮质类固醇激素（＞10 mg/天强的松或等效剂量）或其他免疫抑制剂。没有活动性自身免疫疾病的情况下允许吸入或局部使用类固醇和肾上腺替代类固醇；随机前1周内，接受过全身免疫抑制药物治疗（包括但不仅限于糖皮质激素、环磷酰胺、硫唑嘌呤、甲氨喋呤、沙利度胺和抗肿瘤坏死因子[抗-TNF]药物）。对于接受短期、全身性免疫抑制剂治疗的患者，例如因恶心、呕吐、或过敏反应管理或预防用药给予糖皮质激素，经研究者审核后可以入组该研究。允许使用吸入式糖皮质激素治疗慢性阻塞性肺疾病的患者、盐皮质激素类如氟氢可的松治疗体位性低血压者，和使用低剂量糖皮质激素补充剂治疗肾上腺皮质功能不全；已知有精神疾病、酗酒、无法戒烟、吸毒或药物滥用等情况； 19.经研究者判断，受试者有其他可能导致本研究被迫中途终止的因素，如不依从方案、其他的严重疾病（含精神疾病）需要合并治疗，有严重的实验室检查异常，伴有家庭或社会等因素，会影响到受试者的安全，或资料及样品的收集。

Exclusion criteria：

1. Pregnant and lactating women; 2. previous systemic chemotherapy; 3. previous hormonal cancer therapy or radiation therapy within 5 years prior to enrollment (Surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy more than 5 years prior to enrollment that is currently considered cured is acceptable. Current use of hormone replacement therapy or oral contraceptives is permitted). ; 4. patients who are hearing impaired; 5. known hypersensitivity to any component of the chemotherapy regimen or mannitol that the patient will receive; 6. interstitial lung disease or a history of pneumonia; 7. malignancy other than NSCLC that has occurred within 5 years prior to enrollment, except for those who have had a negligible risk of metastasis or death (e.g., expected 5-year survival greater than 90%) and who have been treated to achieve the expected cure (e.g., adequately treated cervical carcinoma in situ, basal cell or squamous cell skin carcinoma, localized prostate carcinoma treated surgically to achieve cure, and catheter carcinoma in situ treated surgically to achieve cure) . 8. active, known or suspected autoimmune disease including, but not limited to, myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus rheumatoid arthritis, and inflammatory bowel disease. Enrollment is allowed for type I diabetes mellitus (glycemic control with insulin therapy), residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy, or lack of exogenous stimuli that are not expected to recur; patients with eczema, psoriasis, chronic lichen simplex moss, or vitiligo dermatologic manifestations only (psoriatic arthritis needs to be ruled out) may be enrolled if the rash cover less than 10% of the body surface area, have adequately controlled disease at baseline and require only low-potency topical steroid therapy, and have not had an acute exacerbation of the underlying disease in the past 12 months (no need for psoralens plus ultraviolet radiation [PUVA], methotrexate, retinoids, biologics, oral calmodulin phosphatase inhibitors, high potency, or oral steroids) may be enrolled in the study; 9. prior treatment with any T-cell co-stimulation or immune checkpoint therapy, including, but not limited to, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other agents that target T cells; 10. HBsAg positivity with HBV DNA copy number greater than the upper limit of normal (1000 copies/ml or 500 IU/ml) in the laboratory section of the research center, or HCV positivity (HCV RNA or HCV Ab test suggestive of acute or chronic infection); known history of HIV-positive disease or known Acquired Immune Deficiency Syndrome (AIDS); 11. history of idiopathic pulmonary fibrosis, organic pneumonia (e.g., occlusive bronchiectasis), drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or active pneumonitis with clinical symptoms; or other moderately-severe lung disease that severely affects lung function (patients with a history of radiation pneumonitis (fibrosis) present in the radiation area may be eligible for this study) 12. active tuberculosis (TB) or subjects with a history of active TB infection, treated or untreated, within ≤ 48 weeks prior to screening; 13. the presence of severe infections including, but not limited to, complications of infections requiring hospitalization, bacteremia, severe pneumonia, etc; 14. the presence of severe cardiovascular disease such as New York Heart Association (NYHA) class 2 or higher heart failure, unstable angina pectoris, unstable arrhythmia, myocardial infarction or cerebrovascular accident occurring within 3 months prior to randomization 15. patients with a prior allogeneic bone marrow transplant or solid organ transplant; 16. known hypersensitivity to the study drug or excipients, known severe allergic reaction to any of the monoclonal antibodies; 17. have been treated with any other experimental drug or have participated in another interventional clinical study within 4 weeks prior to signing the ICF; 18. use of corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive agents within ≤ 14 days prior to the first dose of study drug. Inhaled or topical steroids and adrenal replacement steroids are permitted in the absence of active autoimmune disease; Systemic immunosuppressive medications (including, but not limited to, glucocorticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] medications) within the 1 week prior to randomization. For patients receiving short-term, systemic immunosuppressive therapy, such as glucocorticoids given for nausea, vomiting, or allergic reaction management or prophylaxis, enrollment in the study is permitted after review by the investigator. Inhaled glucocorticosteroids are permitted for the treatment of patients with chronic obstructive pulmonary disease (COPD), saline corticosteroid analogs such as fludrocortisone for postural hypotension, and low-dose glucocorticoid supplements for the treatment of adrenocortical insufficiency; and known psychiatric disorders, alcoholism, inability to quit smoking, drug addiction, or substance abuse; 19. Subjects who, in the judgment of the investigator, have other factors that may cause this study to be forcibly terminated in midstream, such as non-compliance with the protocol, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, concomitant family or social factors, which would compromise the safety of the subject, or the collection of data and samples.

研究实施时间：

Study execute time：

从 From 2024-11-10 00:00:00至 To 2030-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-11-15 00:00:00 至 To 2025-11-15 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 30

Group：

test group

Sample size：

干预措施：

化疗辅助治疗期： 顺铂/卡铂+长春瑞滨/紫杉醇/多西他赛/培美曲塞（非鳞癌）/吉西他滨，1-4个周期。 免疫辅助治疗期： QL1706, 5 mg/kg, i.v. q3w，16个周期或1年。

干预措施代码：

Intervention：

Adjuvant chemotherapy period: Cisplatin/carboplatin + vincristine/paclitaxel/docetaxel/pemetrexed (non-squamous)/gemcitabine, 1-4 cycles. Immunoadjuvant therapy period: QL1706, 5 mg/kg, i.v. q3w, 16 cycles or 1 year.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 南通市肿瘤医院 

单位级别：

 三甲 

Institution
hospital：

Nantong Cancer Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 南通大学附属医院 

单位级别：

 三甲 

Institution
hospital：

Affiliated Hospital of Nantong University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

无病生存期

指标类型：

主要指标

Outcome：

Disease-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：

ITT人群的总生存期

指标类型：

次要指标

Outcome：

Overall survival in the ITT population

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

PD-L1 TC≥50%人群的DFS

指标类型：

次要指标

Outcome：

DFS in the PD-L1 TC ≥50% population

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

3年和5年的DFS率

指标类型：

次要指标

Outcome：

3- and 5-year DFS rates

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

指标类型：

次要指标

Outcome：

security

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

 其它  

说明

Fate of sample：

0thers  

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 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:

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）：

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：

CRF

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

CRF

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：

  2024-11-12 14:56:48