ChiCTR2600123870 版本V1.0 版本创建时间2026/04/30 15:03:20 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：

 ChiCTR2600123870 

最近更新日期：

Date of Last Refreshed on：

 2026-04-30 15:03:14 

注册时间：

Date of Registration：

 2026-04-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

YMN-M12 腺病毒肿瘤疫苗用于晚期肺癌患者的安全性、耐受性、免疫原性及初步有效性临床研究

Public title：

Safety, Tolerability, Immunogenicity and Preliminary Efficacy of YMN-M12 Adenoviral Tumor Vaccine in Patients with Advanced Lung Cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

YMN-M12 腺病毒肿瘤疫苗用于晚期肺癌患者的安全性、耐受性、免疫原性及初步有效性临床研究

Scientific title：

Safety, Tolerability, Immunogenicity and Preliminary Efficacy of YMN-M12 Adenoviral Tumor Vaccine in Patients with Advanced 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：

林楠 

研究负责人：

马学磊 

Applicant：

Nan Lin 

Study leader：

Xuelei Ma 

申请注册联系人电话：

Applicant telephone：

 +86 28 8542 2683

研究负责人电话：

Study leader's
telephone：

+86 28 8542 2683

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：

 linnan@stu.scu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 linnan@stu.scu.edu.cn

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：

中国四川省成都市武侯区国学巷37号

研究负责人通讯地址：

四川省成都市武侯区国学巷37号

Applicant address：

37, Guoxue Lane, Wuhou District, Chengdu, Sichuan,China

Study leader's address：

37, Guoxue Lane, Wuhou District, Chengdu, Sichuan,China

申请注册联系人邮政编码：

Applicant postcode：

 067513

研究负责人邮政编码：

Study leader's postcode：

 067513

申请人所在单位：

四川大学华西医院

Applicant's institution：

West China Hospital, Sichuan University

研究负责人所在单位：

四川大学华西医院

Affiliation of the Leader：

West China Hospital, Sichuan University

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：

 2026年审(859)号

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：

四川大学华西医院生物医学伦理审查委员会

Name of the ethic committee：

Biomedical Ethics Committee of West China Hospital, Sichuan University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-22 00:00:00

伦理委员会联系人：

邓绍林

Contact Name of the ethic committee：

Shaolin Deng

伦理委员会联系地址：

中国四川省成都市武侯区国学巷37号

Contact Address of the ethic committee：

37, Guoxue Lane, Wuhou District, Chengdu, Sichuan,China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 28 8542 2654

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：

四川大学华西医院

Primary sponsor：

West China Hospital, Sichuan University

研究实施负责（组长）单位地址：

中国四川省成都市武侯区国学巷37号

Primary sponsor's address：

37, Guoxue Lane, Wuhou District, Chengdu, Sichuan,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)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

四川大学华西医院

具体地址：

中国四川省成都市武侯区国学巷37号

Institution
hospital：

West China Hospital, Sichuan University

Address：

37, Guoxue Lane, Wuhou District, Chengdu, Sichuan,China

经费或物资来源：

SCI经费

Source(s) of funding：

SCI funding

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：

单臂 

Study design：

Single arm 

研究目的：

1. 主要目的：本研究拟评价 YMN-M12 腺病毒呼吸道黏膜治疗联合二线标准抗肿瘤治疗用于晚期肺癌患者的安全性、耐受性、免疫原性及初步有效性。 2. 次要目的：评价YMN-M12腺病毒呼吸道黏膜联合二线标准抗肿瘤治疗用于晚期肺癌患者的免疫原性及初步有效性。  

Objectives of Study：

1. Primary objective: This study aims to evaluate the safety, tolerability, immunogenicity and preliminary efficacy of YMN-M12 adenovirus respiratory mucosal therapy combined with second-line standard anti-tumor therapy in patients with advanced lung cancer. 2. Secondary objective: To evaluate the immunogenicity and preliminary efficacy of YMN-M12 adenovirus respiratory mucosa combined with second-line standard anti-tumor therapy in patients with advanced 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. 自愿签署书面知情同意书，能够理解并遵守研究方案要求，可按时完成所有访视、检查及治疗流程。 2. 年龄 18~75 周岁，性别不限。 3. 经组织学或细胞学确诊的原发性非小细胞肺癌，按照 AJCC 第 8 版 TNM 分期标准，确诊为 IV 期（任何 T、任何 N、M1），或 IIIb/IIIc 期局部晚期不可手术切除、无法接受根治性同步放化疗，或根治性治疗后出现疾病进展的患者。 4. 经免疫组化（IHC）检测证实，肿瘤组织中 IMP3 蛋白表达阳性（定义：IHC 染色阳性肿瘤细胞占比>=5%，对于 IHC 结果不明确、边界性表达或研究预设需要的样本，可进一步采用 FISH 进行补充验证）。 5. 既往接受过一线标准抗肿瘤治疗后疾病进展、复发或不耐受，且研究者判断适合接受二线标准抗肿瘤治疗的晚期非小细胞肺癌患者。具体要求如下： （1）驱动基因阳性（EGFR/ALK/ROS1 等）非小细胞肺癌（NSCLC）：既往已接受与其分子分型相匹配的一线标准治疗后疾病进展、复发或不耐受，研究者判断适合接受二线标准抗肿瘤治疗者； （2）驱动基因阴性 NSCLC：既往已接受一线标准系统抗肿瘤治疗后疾病进展、复发或不耐受，研究者判断适合接受二线标准抗肿瘤治疗者。 6. ECOG 体力状态评分 0~1 分，预计生存期>=3 个月。 7. 基线实验室检查满足以下器官功能要求（检查距入组时间<=7 天）： （1）血常规：中性粒细胞绝对值（ANC）>=1.5×10^9/L，血小板（PLT）>=100×10^9/L，血红蛋白（Hb）>=90g/L； （2）肝功能：AST/ALT<=2.5×ULN（肝转移患者<=5×ULN），总胆红素<=1.5×ULN（肝转移患者<=3×ULN）； （3）肾功能：血清肌酐<=1.5×ULN，或肌酐清除率>=50mL/min（Cockcroft-Gault 公式）； （4）凝血功能：INR<=1.5，APTT<=1.5×ULN。 8. 育龄期女性受试者入组前血妊娠试验阴性，所有育龄期受试者（男女）均同意在研究期间及研究结束后 6 个月内采取医学认可的有效避孕措施。 9. 可提供足够的存档或新鲜肿瘤组织标本，用于 IMP3 表达检测及后续生物标志物分析。

Inclusion criteria

1. Voluntarily sign the written informed consent form, understand and comply with the requirements of the study protocol, and be able to complete all visits, examinations and treatment procedures on schedule. 2. Aged 18-75 years, regardless of gender. 3. Patients with primary non-small cell lung cancer (NSCLC) confirmed by histopathology or cytopathology; classified as Stage IV (any T, any N, M1) or Stage IIIb/IIIc locally advanced unresectable disease according to the 8th edition of the AJCC TNM staging system, who are ineligible for curative concurrent chemoradiotherapy, or have experienced disease progression after curative treatment. 4. Positive IMP3 protein expression in tumor tissues confirmed by immunohistochemistry (IHC) testing (definition: the proportion of IHC-positive tumor cells >= 5%). For samples with unclear IHC results, borderline expression or as prespecified in the study, further supplementary verification by FISH is allowed. 5. Patients with advanced NSCLC who have experienced disease progression, recurrence or intolerance after prior first-line standard anti-tumor therapy, and are judged by the investigator to be suitable for second-line standard anti-tumor treatment. Specific requirements are as follows: (1) Driver gene-positive NSCLC (EGFR/ALK/ROS1, etc.): disease progression, recurrence or intolerance after first-line standard treatment matched to molecular typing, and eligible for second-line standard anti-tumor therapy as assessed by the investigator; (2) Driver gene-negative NSCLC: disease progression, recurrence or intolerance after prior first-line standard systemic anti-tumor therapy, and suitable for second-line standard anti-tumor treatment as judged by the investigator. 6. ECOG performance status score of 0-1, with an estimated survival time >= 3 months. 7. Baseline laboratory tests meet the following organ function criteria (tests conducted within 7 days prior to enrollment): (1) Blood routine: absolute neutrophil count (ANC) >= 1.5×10^9/L, platelet (PLT) >= 100×10^9/L, hemoglobin (Hb) >= 90 g/L; (2) Liver function: AST/ALT <= 2.5×ULN (<= 5×ULN for patients with liver metastases), total bilirubin <= 1.5×ULN (<= 3×ULN for patients with liver metastases); (3) Renal function: serum creatinine <= 1.5×ULN, or creatinine clearance >= 50 mL/min (calculated by the Cockcroft-Gault formula); (4) Coagulation function: INR <= 1.5, APTT <= 1.5×ULN. 8. Negative serum pregnancy test for women of childbearing potential before enrollment; all subjects of childbearing potential (male and female) agree to adopt medically recognized effective contraceptive measures during the study period and for 6 months after study completion. 9. Able to provide adequate archived or fresh tumor tissue specimens for IMP3 expression detection and subsequent biomarker analysis.

排除标准：

1. 对 Ad5 腺病毒载体、疫苗辅料、IL-12 类药物存在明确过敏史，或既往对同类生物制剂发生过严重过敏反应的患者。 2. 存在影响经鼻给药安全性、耐受性或药物黏膜吸收的鼻腔/鼻窦疾病或解剖异常者，包括但不限于：重度鼻炎（含重度过敏性鼻炎）、活动性鼻窦炎、鼻息肉、严重萎缩性鼻炎、反复鼻出血、鼻腔恶性肿瘤、明显鼻腔结构异常（如明显鼻中隔偏曲等）、筛查前 3个月内接受过鼻腔或鼻窦手术，或其他研究者判断不适合接受滴鼻给药的情况。 3. 既往接受过靶向 IMP3 的抗肿瘤治疗、Ad5 载体疫苗治疗、或重组 IL-12 类药物治疗的患者。 4. 存在活动性自身免疫性疾病病史（如系统性红斑狼疮、类风湿关节炎、多发性硬化、自身免疫性肺炎 / 肝炎 / 肠炎等），或过去 2 年内需要全身性免疫抑制剂 / 糖皮质激素治疗的自身免疫性疾病患者；吸入 / 局部用糖皮质激素、甲状腺素替代治疗除外。 5. 经胸部影像学证实存在活动性间质性肺病、肺纤维化，或有非感染性肺炎病史需要全身性激素治疗的患者。 6. 存在有症状的中枢神经系统（CNS）转移、癌性脑膜炎，或需要激素 / 脱水治疗控制颅内症状的 CNS 转移患者；无症状、稳定的 CNS 转移（完成局部治疗后>=4 周，影像学无进展，无需激素治疗）除外。 7. 存在活动性感染，包括： （1）需要静脉抗感染治疗的细菌、真菌、病毒感染； （2）活动性结核病； （3）HBsAg 阳性且 HBV DNA 高于检测下限（未接受规范抗病毒治疗）； （4）HCV RNA 阳性； （5）HIV 抗体阳性。 8. 存在严重的基础器质性疾病，包括： （1）纽约心脏病协会（NYHA）III-IV 级充血性心力衰竭、不稳定型心绞痛、入组前 6 个月内发生过心肌梗死 / 脑卒中、严重控制不佳的心律失常； （2）肝硬化失代偿期、慢性肾功能衰竭需要规律透析； （3）未控制的重度高血压、糖尿病（经规范治疗后仍不达标）。 9. 入组前 2 周内使用过全身性糖皮质激素（剂量>=10mg / 天泼尼松等效剂量），或其他免疫抑制剂治疗的患者；吸入 / 局部用糖皮质激素、激素止吐治疗除外。 10. 存在无法控制的胸腔积液、腹水、心包积液，需要反复穿刺引流（入组前 4 周内引流>=2 次）的患者；或存在巨块型肿瘤（靶病灶最大径>=10cm）、广泛骨转移伴严重骨痛 / 高钙血症的患者。 11. 妊娠或哺乳期女性。 12. 入组前 3 个月内参与过其他临床试验，接受过其他试验药物 / 器械治疗的患者。 13. 存在已知的先天性或获得性严重免疫缺陷疾病（如重症联合免疫缺陷病、DiGeorge 综合征等），或既往接受过器官移植、异基因造血干细胞移植的患者。 14. 存在精神疾病、认知障碍，无法理解知情同意内容、无法配合完成研究流程的患者。 15. 研究者判断存在其他可能危及受试者安全、干扰研究结果评价、或导致受试者无法完成研究的情况。

Exclusion criteria：

1. Patients with a clear history of allergy to Ad5 adenovirus vector, vaccine excipients, IL-12-related drugs, or previous severe hypersensitivity reactions to similar biological agents. 2. Patients with nasal/sinus diseases or anatomical abnormalities that may affect the safety, tolerability or mucosal absorption of intranasal administration, including but not limited to: severe rhinitis (including severe allergic rhinitis), active sinusitis, nasal polyps, severe atrophic rhinitis, recurrent epistaxis, nasal malignant tumors, obvious nasal structural abnormalities (e.g., severe nasal septum deviation); those who have undergone nasal or sinus surgery within 3 months before screening, or other conditions deemed unsuitable for intranasal administration by the investigator. 3. Patients with prior receipt of IMP3-targeted anti-tumor therapy, Ad5 vector vaccine treatment, or recombinant IL-12-related drug therapy. 4. Patients with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, autoimmune pneumonia/hepatitis/enteritis, etc.), or autoimmune diseases requiring systemic immunosuppressant/glucocorticoid treatment within the past 2 years; patients using inhaled/topical glucocorticoids or thyroid hormone replacement therapy are excluded. 5. Patients with active interstitial lung disease, pulmonary fibrosis confirmed by chest imaging, or a history of non-infectious pneumonia requiring systemic hormone therapy. 6. Patients with symptomatic central nervous system (CNS) metastasis, carcinomatous meningitis, or CNS metastasis requiring hormone/dehydration therapy to control intracranial symptoms; asymptomatic and stable CNS metastasis (>= 4 weeks after local treatment, no radiological progression, and no need for hormone therapy) is excluded. 7. Patients with active infections, including: (1) Bacterial, fungal or viral infections requiring intravenous anti-infective treatment; (2) Active tuberculosis; (3) HBsAg positive with HBV DNA above the lower limit of detection (without standardized antiviral treatment); (4) HCV RNA positive; (5) HIV antibody positive. 8. Patients with severe underlying organic diseases, including: (1) NYHA Class III-IV congestive heart failure, unstable angina, myocardial infarction/stroke within 6 months before enrollment, and severe uncontrolled arrhythmia; (2) Decompensated liver cirrhosis, chronic renal failure requiring regular dialysis; (3) Uncontrolled severe hypertension or diabetes (poorly controlled despite standardized treatment). 9. Patients who have received systemic glucocorticoids (prednisone equivalent dose >= 10 mg/day) or other immunosuppressants within 2 weeks before enrollment; inhaled/topical glucocorticoids and hormone antiemetic treatment are excluded. 10. Patients with uncontrolled pleural effusion, ascites or pericardial effusion requiring repeated puncture and drainage (>= 2 drainage procedures within 4 weeks before enrollment); or patients with massive tumors (maximum diameter of target lesion >= 10 cm), extensive bone metastasis accompanied by severe bone pain or hypercalcemia. 11. Pregnant or lactating women. 12. Patients who have participated in other clinical trials and received other investigational drugs/devices within 3 months before enrollment. 13. Patients with known congenital or acquired severe immunodeficiency diseases (such as severe combined immunodeficiency, DiGeorge syndrome, etc.), or with a history of organ transplantation or allogeneic hematopoietic stem cell transplantation. 14. Patients with mental disorders or cognitive impairment who are unable to understand the informed consent content or cooperate with the study procedures. 15. Any other conditions judged by the investigator that may endanger the subject's safety, interfere with the evaluation of study results, or prevent the subject from completing the study.

研究实施时间：

Study execute time：

从 From 2026-05-01 00:00:00至 To 2028-05-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2028-05-01 00:00:00

干预措施：

Interventions：

组别：

治疗组

样本量：

 9

Group：

Treatment group

Sample size：

干预措施：

本研究采用“3+3”剂量递增设计，设置3个剂量水平。剂量水平1（DL1）：2×10^10 /次 ，剂量水平2（DL2）：4×10^10 /次 ，剂量水平3（DL3）：8×10^10 /次 。YMN-M12采用呼吸道黏膜给药方式，于每周期第1天（Day 1）给药1次。原则上，YMN-M12应在该周期标准抗肿瘤治疗（包括标准免疫治疗和/或标准化疗）开始前给药；如需在同日完成，建议先给予YMN-M12，再实施该周期标准治疗。若因临床实际情况无法同日完成，研究者可在判断受试者安全且不影响联合治疗评价的前提下，于该周期标准抗肿瘤治疗开始前完成YMN-M12给药，并应在病历及电子病例报告表中记录实际给药日期、时间及原因。

干预措施代码：

Intervention：

This study adopts a "3+3" dose escalation design with 3 dose levels. Dose level 1 (DL1) : 2×10^10 per time, dose level 2 (DL2) : 4×10^10 per time, dose level 3 (DL3) : 8×10^10 per time.YMN-M12 is administered once on Day 1 of each cycle. In principle, YMN-M12 should be administered before the start of standard anti-tumor therapy (including standard immunotherapy and/or standard chemotherapy) in the cycle; if it needs to be completed on the same day, it is recommended to administer YMN-M12 first and then implement the standard treatment of the cycle. If it cannot be completed on the same day due to actual clinical conditions, the investigator may complete the administration of YMN-M12 before the start of the standard anti-tumor therapy in the cycle under the premise that it is safe for the subject and does not affect the evaluation of combination therapy, and the actual date, time and reason of administration should be recorded in the medical record and electronic case report form.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

 成都 

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

 四川大学华西医院 

单位级别：

 三甲 

Institution
hospital：

West China Hospital, Sichuan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

安全性

指标类型：

主要指标

Outcome：

Safety

Type：

Primary indicator

测量时间点：

治疗期间及随访时

测量方法：

患者主观反馈及客观检验结果

Measure time point of outcome：

During treatment and follow-up.

Measure method：

Patient-reported feedback and objective test results.

指标中文名：

剂量限制性毒性

指标类型：

主要指标

Outcome：

Dose limiting toxicity, DLT

Type：

Primary indicator

测量时间点：

首次给药后28天内

测量方法：

CTCAE v5.0

Measure time point of outcome：

Within 28 days after the first dose.

Measure method：

CTCAE v5.0

指标中文名：

初步有效性检测

指标类型：

次要指标

Outcome：

Preliminary effectiveness testing

Type：

Secondary indicator

测量时间点：

基线影像应在首次给药前28天内完成；此后于第6周、第12周进行首次和第二次疗效评估；之后每9周至第48周复查一次；第48周后改为每12周复查一次，直至影像学进展、开始新的抗肿瘤治疗、撤回知情同意、失访

测量方法：

影像学检查以胸部及上腹部增强CT为基础，必要时结合脑MRI、骨扫描、PET/CT或其他部位影像。

Measure time point of outcome：

Baseline imaging should be completed within 28 days before the first dose. Thereafter, the first and second efficacy assessments will be performed at Week 6 and Week 12, respectively; subsequently, imaging assessments will be repeated every 9 weeks until Week 48. After Week 48, imaging assessments will be performed every 12 weeks until radiographic progression, initiation of new anti-tumor therapy, withdrawal of informed consent, or loss to follow-up.

Measure method：

Imaging examinations will be based on contrast-enhanced CT of the chest and upper abdomen, with brain MRI, bone scan, PET/CT, or imaging of other sites performed as clinically indicated.

指标中文名：

特异性免疫反应

指标类型：

次要指标

Outcome：

Specific immune response

Type：

Secondary indicator

测量时间点：

基线、第6周、第12周、EOT

测量方法：

采用 ELISpot、流式细胞术胞内细胞因子染色（ICS）或其他经验证的方法，检测 IMP3 特异性 T 细胞反应

Measure time point of outcome：

Baseline, Week 6, Week 12, and EOT.

Measure method：

IMP3-specific T-cell responses will be assessed using ELISpot, intracellular cytokine staining (ICS) by flow cytometry, or other validated methods.

指标中文名：

载体脱落/排出监测

指标类型：

次要指标

Outcome：

Vehicle shedding/discharge monitoring

Type：

Secondary indicator

测量时间点：

治疗期间及随访时

测量方法：

通过鼻拭子、咽拭子/唾液，必要时尿液或血液，采用核酸检测方法观察载体脱落情况。

Measure time point of outcome：

During treatment and follow-up.

Measure method：

Vector shedding will be assessed by nucleic acid testing of nasal swabs, throat swabs/saliva, and, if necessary, urine or blood samples.

指标中文名：

免疫原性检测

指标类型：

次要指标

Outcome：

Immunogenicity tests

Type：

Secondary indicator

测量时间点：

基线、第6周、第12周、EOT

测量方法：

检测外周血淋巴细胞亚群（CD3、CD4、CD8、NK、B细胞）、Treg 比例等，用于描述全身免疫状态变化。

Measure time point of outcome：

Baseline, Week 6, Week 12, and EOT.

Measure method：

Peripheral blood lymphocyte subsets (CD3, CD4, CD8, NK cells, and B cells) and the proportion of Treg cells will be assessed to describe changes in systemic immune status.

指标中文名：

生命体征、体格检查和局部耐受性

指标类型：

主要指标

Outcome：

Vital signs, physical examination and local tolerance

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

细胞因子/药效学指标

指标类型：

次要指标

Outcome：

Cytokines/pharmacodynamic indicators

Type：

Secondary indicator

测量时间点：

基线、第6周、第12周、EOT

测量方法：

Measure time point of outcome：

Baseline, Week 6, Week 12, and EOT.

Measure method：

指标中文名：

影像学疗效评价

指标类型：

次要指标

Outcome：

Evaluation of imaging efficacy

Type：

Secondary indicator

测量时间点：

测量方法：

疗效按 RECIST 1.1 评价

Measure time point of outcome：

Measure method：

The therapeutic effect was evaluated according to RECIST 1.1

指标中文名：

肿瘤疗效指标（包括客观缓解率（ORR）、疾病控制率（DCR）、缓解持续时间（DoR）、无进展 生存期（PFS）及总生存期（OS）等初步疗效指标。）

指标类型：

次要指标

Outcome：

Tumor efficacy indicators(This includes preliminary efficacy indicators such as objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), and overall survival (OS).)

Type：

Secondary indicator

测量时间点：

测量方法：

疗效按 RECIST 1.1 评价

Measure time point of outcome：

Measure method：

The therapeutic effect was evaluated according to RECIST 1.1

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：

鼻拭子

组织：

Sample Name：

Nasal swab

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：

本研究的数据采集和管理由病例报告表/电子病例报告表（Case Record Form/electronic Case Record Form，CRF/eCRF）和电子数据采集系统（Electronic Data Capture，EDC）两部分组成。研究开始前，应完成 CRF/eCRF、数据管理计划、统计分析计划、数据录入与核查流程、质疑处理流程、数据更正规则、数据库锁定流程及资料归档要求的制定和确认。 本研究所有数据均应来源于可核查的原始记录，包括但不限于知情同意记录、筛查记录、人口学资料、既往史、肿瘤病史、既往抗肿瘤治疗史、合并疾病及合并用药、体格检查、ECOG 评分、生命体征、实验室检查结果、影像学检查结果、给药记录、不良事件和严重不良事件、免疫原性检测结果、载体脱落检测结果、随访记录、停药或退出研究记录等。研究者或经授权的研究人员应及时、准确、完整、规范地将相关数据录入 CRF/eCRF，不得事后集中补记。 EDC 系统用于研究数据的电子化录入、保存、审核、质疑、修改、导出和数据库锁定。系统访问权限应实行分级授权和最小必要权限原则，仅限经授权的研究者、研究护士、数据管理员、监查员、稽查员、伦理委员会及监管部门人员在各自职责范围内访问相关数据。受试者资料应采用唯一受试者识别代码进行去标识化管理，姓名、身份证号、联系方式等可直接识别个人身份的信息应与研究数据库分开保存，以保护受试者隐私和个人信息安全。 数据管理过程中，应对 CRF/eCRF 数据进行完整性、准确性、逻辑一致性、范围合理性、访视时间窗及与原始资料一致性的核查。对于缺失、矛盾、异常或不符合方案要求的数据，数据管理员或监查人员应及时发出数据质疑，研究现场应在规定时限内完成核实、回复和必要更正。所有数据更正均应保留原始记录、修改后内容、修改日期、修改人员及修改原因，确保数据全过程可追溯。 数据库锁定前，应完成全部预设数据核查、关键质疑关闭、主要方案偏离评估、关键终点评审、分析数据集确认及统计程序复核。数据库锁定后，如确需解锁修改数据，应履行书面审批程序，并记录解锁原因、涉及范围、修改内容、再次锁定时间及其对统计分析结果的可能影响。研究结束后，应按照预设统计分析计划完成安全性、耐受性、免疫原性及初步有效性分析，并形成研究总结报告。所有 CRF/eCRF 数据、原始资料、质疑记录、审计追踪记录、样本台账、药物管理记录及其他研究相关文件均应按照 GCP 和研究机构要求妥善保存和归档。

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

Data collection and management in this study will consist of two components: the Case Record Form/electronic Case Record Form (CRF/eCRF) and the Electronic Data Capture (EDC) system. Before study initiation, the CRF/eCRF, data management plan, statistical analysis plan, data entry and verification procedures, query management procedures, data correction rules, database locking procedures, and document archiving requirements will be developed and confirmed. All study data shall be derived from verifiable source documents, including but not limited to informed consent records, screening records, demographic information, medical history, tumor history, prior anti-tumor treatment history, concomitant diseases and concomitant medications, physical examination findings, ECOG performance status, vital signs, laboratory test results, imaging results, dosing records, adverse events and serious adverse events, immunogenicity results, vector shedding results, follow-up records, and records of treatment discontinuation or study withdrawal. The investigator or authorized study personnel shall enter relevant data into the CRF/eCRF in a timely, accurate, complete, and standardized manner. Retrospective batch entry without contemporaneous source documentation shall be avoided. The EDC system will be used for electronic data entry, storage, review, query management, modification, export, and database locking. Access to the EDC system shall be role-based and follow the principle of minimum necessary access. Only authorized investigators, study nurses, data managers, monitors, auditors, ethics committee members, and regulatory authorities may access relevant data within the scope of their responsibilities. Subject data will be de-identified using a unique subject identification code. Direct personal identifiers, such as name, identification number, and contact information, shall be stored separately from the study database to protect subject privacy and personal information security. During data management, CRF/eCRF data will be checked for completeness, accuracy, logical consistency, reasonable range, visit-window compliance, and consistency with source documents. For missing, inconsistent, abnormal, or protocol-noncompliant data, data queries shall be issued by the data manager or monitor in a timely manner, and the study site shall verify, respond to, and correct the data within the required timeframe. All data corrections shall retain the original record, corrected content, date of correction, person making the correction, and reason for correction, so that the entire data trail remains traceable and auditable. Before database lock, all predefined data checks, closure of key queries, assessment of major protocol deviations, review of key endpoints, confirmation of analysis datasets, and validation of statistical programs shall be completed. After database lock, if database unlocking and data modification are necessary, written approval shall be obtained, and the reason for unlocking, scope involved, content of modification, time of re-locking, and potential impact on statistical analysis results shall be documented. After study completion, analyses of safety, tolerability, immunogenicity, and preliminary efficacy will be performed according to the predefined statistical analysis plan, and a clinical study report will be prepared. All CRF/eCRF data, source documents, query records, audit trail records, sample logs, investigational product management records, and other study-related documents shall be properly retained and archived in accordance with GCP and institutional requirements.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-04-30 15:03:14