ChiCTR2600117819 版本V1.0 版本创建时间2026/01/29 09:44:59 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：

ChiCTR2600117819 

最近更新日期：

Date of Last Refreshed on：

2026-01-29 09:44:46 

注册时间：

Date of Registration：

2026-01-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评价VSV-01联合OVV-00多种给药方式治疗晚期实体瘤安全性、耐受性及初步疗效的开放临床研究

Public title：

An Open-Label Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of VSV-01 Combined with OVV-00 via Multiple Routes of Administration in Patients with Advanced Solid Tumors

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评价VSV-01联合OVV-00多种给药方式治疗晚期实体瘤安全性、耐受性及初步疗效的开放临床研究

Scientific title：

An Open-Label Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of VSV-01 Combined with OVV-00 via Multiple Routes of Administration in Patients with Advanced Solid Tumors

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：

李伟伟 

研究负责人：

李伟伟 

Applicant：

Weiwei Li 

Study leader：

Weiwei Li 

申请注册联系人电话：

Applicant telephone：

+86 373 440 3114

研究负责人电话：

Study leader's telephone：

+86 373 440 3114

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：

13837384916@163.com

研究负责人电子邮件：

Study leader's E-mail：

13837384916@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：

河南省新乡市卫辉市健康路88号

研究负责人通讯地址：

河南省新乡市卫辉市健康路88号

Applicant address：

No. 88, Health Road, Weihui City, Xinxiang City, Henan Province

Study leader's address：

No. 88, Health Road, Weihui City, Xinxiang City, Henan 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：

新乡医学院第一附属医院

Applicant's institution：

The First Affiliated Hospital of Xinxiang Medical University

研究负责人所在单位：

新乡医学院第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Xinxiang Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

[2025]伦科会审字(31)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：

新乡医学院第一附属医院科研伦理审查小组

Name of the ethic committee：

The Ethics Committee of the First Affiliated Hospital of Xinxiang Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-06 00:00:00

伦理委员会联系人：

赵嘉林

Contact Name of the ethic committee：

Jialin Zhao

伦理委员会联系地址：

河南省新乡市卫辉市健康路88号

Contact Address of the ethic committee：

No. 88, Health Road, Weihui City, Xinxiang City, Henan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 373 4402079

伦理委员会联系人邮箱：

Contact email of the ethic committee：

460169003@qq.com

研究实施负责（组长）单位：

新乡医学院第一附属医院

Primary sponsor：

The First Affiliated Hospital of Xinxiang Medical University

研究实施负责（组长）单位地址：

河南省新乡市卫辉市健康路88号

Primary sponsor's address：

No. 88, Health Road, Weihui City, Xinxiang City, Henan 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)：

河南省

市(区县)：

Country：

China

Province：

Henan

City：

单位(医院)：

新乡医学院第一附属医院

具体地址：

河南省新乡市卫辉市健康路88号

Institution
hospital：

The First Affiliated Hospital of Xinxiang Medical University

Address：

No. 88, Health Road, Weihui City, Xinxiang City, Henan Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected topic (self-funded)

Target disease：

Advanced solid tumors

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：

评估VSV-01联合OVV-00的多种给药方式在晚期实体瘤受试者中的安全性和耐受性，以确定最大耐受剂量（MTD）和II期推荐剂量（RP2D）。  

Objectives of Study：

To evaluate the safety and tolerability of multiple dosing regimens of VSV-01 in combination with OVV-00 in subjects with advanced solid tumors, with the aim of determining the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D).

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.自愿签署知情同意书，了解本研究并愿意遵循方案而且愿意完成所有试验程序； 2.签署ICF时年龄>=18周岁，性别不限。 3.经过对原发灶和/或转移灶病理组织学/细胞学检查确诊的晚期实体瘤受试者。 4.经标准治疗失败，缺乏标准治疗的末线受试者或因医学原因，不适合标准治疗的受试者。 5.受试者须至少存在一个根据 RECIST·1.1 标准判定为可测量的病灶。 6.ECOG体能状态评分为0-2，且预计生存期不少于12周的受试者。 7.有足够的器官和造血功能 8.有生育能力的女性必须在开始治疗前7天内行妊娠试验且结果为阴性。 9.有生育能力的男性和女性受试者必须同意在试验期间和末次给药后至少6个月内使用可靠的避孕方法。

Inclusion criteria

1. Voluntarily sign the informed consent form, understand this study, be willing to follow the protocol and complete all trial procedures; 2. When signing the ICF, the age should be >= 18 years old, and gender is not restricted. 3. Late-stage solid tumor subjects diagnosed by pathological histology/cytology examination of the primary lesion and/or metastatic lesion. 4. Subjects who have failed standard treatment, are at the end-line stage and have no access to standard treatment due to medical reasons. 5. Subjects must have at least one measurable lesion according to the RECIST·1.1 standard. 6. ECOG performance status score of 0-2, and expected survival period of no less than 12 weeks. 7. Sufficient organ and hematopoietic functions. 8. Female subjects with fertility must undergo a pregnancy test 7 days before starting treatment and the result must be negative. 9. Male and female subjects with fertility must agree to use reliable contraceptive methods during the trial and for at least 6 months after the last administration.

排除标准：

1.已知脑转移和/或临床怀疑肿瘤脑转移者（但无症状脑转移或经局部治疗后临床稳定超过3个月的受试者可以入组）； 2.靶病灶2月内曾行放疗的受试者； 3.既往5年内患有其他活动性恶性肿瘤的受试者。已经完全治愈且不需要随访治疗的受试者除外，恶性肿瘤在适应症范围内的受试者除外； 4.用于注射的病灶最长直径>100 mm； 5.受试者在既往4周内参加过或正在参加其他药物或医疗器械的临床试验； 6.准备进行或者既往接受过组织/器官移植的受试者； 7.人类免疫缺陷病毒（HIV）感染且12个月内存在AID相关的机会性感染，或CD4+ T-cell (CD4+)计数＜ 350 cells/uL 的受试者；筛选期乙肝表面抗原（HBsAg）和/或乙肝核心抗体（HBcAb）阳性，且HBV-DNA高于可测量下限，筛选期HCV抗体阳性且HCV-RNA高于可测量下限的受试者；梅毒螺旋体血清学反应阳性受试者； 8.研究期间需使用抗病毒药物或首次给药时在抗病毒药物5个半衰期内的受试者。 9.研究期间需使用治疗性抗凝药物的受试者。 10.根据CTCAE v5.0，受试者有未控制的>=3级活动性感染且具有显著临床相关性； 11.首次给药前4周内接受过化疗、放疗、生物治疗、内分泌治疗、免疫治疗等抗肿瘤药物治疗； 首次给药前 2 周内或 5 个半衰期内（以时间长的为准）接受过小分子靶向治疗和口服氟尿嘧啶类药物；首次给药前2周内接受具有抗肿瘤适应症的中草药或中成药；首次给药前6 周内接受过亚硝基脲或丝裂霉素 C；允许非靶病灶的姑息性放疗（首次给药前>=2 周）； 12.药物未能控制的高血压或肺动脉高压或不稳定型心绞痛；给药前6个月内有过心肌梗死或搭桥、支架手术；纽约心脏病协会（NYHA）标准3-4级的慢性心力衰竭病史；需要治疗的严重心律失常（经研究者判断对试验无影响的房颤、阵发性室上性心动过速除外），包括 QTcF 男性>=450ms、女性>=470ms（以 Fridericia 公式计算）；入组前 6 个月内脑血管意外（CVA）或短暂性脑缺血发作（TIA）等； 13.有活动性自身免疫性疾病或者有自身免疫性疾病史但可能复发的受试者 14.首次给药前14天内或研究期间需要接受全身用皮质类固醇（＞10mg /天强的松或等效剂量）或其他免疫抑制药物治疗的受试者 15.受试者有位于高风险位置的肿瘤（包括位于粘膜区，或靠近气道、大血管或脊髓），其可能导致因肿瘤肿大而造成闭塞或压迫，或因坏死而侵蚀到主要血管，或包裹主要的血管结构（如颈动脉），与重要的神经血管结构相邻的肿瘤，或其他被认为不适合瘤内注射的肿瘤； 16.受试者在筛选期和治疗期需接种任何活疫苗； 17.受试者对研究药物、免疫治疗或相关药物的任何成分过敏； 18.伴有精神疾病、酗酒、无法戒烟、吸毒或药物滥用等情况的受试者； 19.妊娠或哺乳期女性； 20.既往抗肿瘤治疗的不良反应尚未恢复到（CTCAE 5.0） 1 级 (脱发除外)； 21.经研究者判定患有严重不可控疾病，或者存在其他情况，可能会影响接受本研究治疗，认为不适合参与本研究； 22.其他研究者认为不适合入组的情况。

Exclusion criteria：

1. Subjects with known brain metastases and/or clinically suspected brain metastases (but asymptomatic brain metastases or those that have been clinically stable for more than 3 months after local treatment can be included); 2. Subjects whose target lesions have received radiotherapy within 2 months; 3. Subjects who have had other active malignant tumors within the past 5 years. Subjects who have been completely cured and do not require follow-up treatment are excluded, as are those with malignant tumors within the indication range; 4. The longest diameter of the injection site lesion is > 100 mm; 5. Subjects who have participated in or are currently participating in other clinical trials of drugs or medical devices within the past 4 weeks; 6. Subjects who are preparing for or have previously undergone organ/organ transplantation; 7. Subjects with human immunodeficiency virus (HIV) infection and opportunistic infections related to AIDS within 12 months, or with a CD4+ T-cell (CD4+) count < 350 cells/uL; Subjects whose screening period HBsAg and/or HBcAb are positive and HBV-DNA is above the measurable limit, and whose HCV antibody is positive and HCV-RNA is above the measurable limit during the screening period; Subjects with positive serological reaction of Treponema pallidum; 8. Subjects who need to use antiviral drugs during the study period or are within 5 half-lives of the first administration of antiviral drugs; 9. Subjects who need to use therapeutic anticoagulant drugs during the study period; 10. According to CTCAE v5.0, subjects have uncontrolled >= 3 grade active infections with significant clinical relevance; 11. Subjects who received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, etc. as anti-tumor drugs within 4 weeks before the first administration; Subjects who received small molecule targeted therapy and oral fluorouracil drugs within 2 weeks before or 5 half-lives (whichever is longer) before the first administration; Subjects who received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before the first administration; Subjects who received nitrosourea or mitomycin C within 6 weeks before the first administration; Allow palliative radiotherapy of non-target lesions (first administration >= 2 weeks before); 12. Uncontrolled hypertension or pulmonary hypertension or unstable angina pectoris during the study period; Subjects who had myocardial infarction or bypass, stent surgery within 6 months before the administration; Subjects with a history of chronic heart failure of NYHA standard 3-4; Severe arrhythmias that require treatment (except for atrial fibrillation and paroxysmal supraventricular tachycardia judged by the investigator not to affect the trial) including QTcF for males >= 450ms, females >= 470ms (calculated by Fridericia formula); Subjects with cerebrovascular accidents (CVA) or transient ischemic attacks (TIA) or other cerebrovascular accidents within 6 months before enrollment; 13. Subjects with active autoimmune diseases or those with a history of autoimmune diseases that may recur; 14. Subjects who need to receive systemic corticosteroids (> 10mg/day prednisone or equivalent dose) or other immunosuppressive drugs during the study period within 14 days before the first administration; 15. Subjects with tumors located in high-risk areas (including in mucosal areas, or close to airways, major blood vessels or spinal cord), which may cause occlusion or compression due to tumor enlargement, or erosion into major blood vessels due to necrosis, or encapsulation of major vascular structures (such as carotid arteries), or tumors adjacent to important neurovascular structures, or other tumors considered unsuitable for intratumoral injection; 16. Subjects need to receive any live vaccines during the screening period and treatment period; 17. Subjects are allergic to the study drug, immunotherapy or any component of related drugs; 18. Subjects with mental illness, alcoholism, inability to quit smoking, drug abuse or drug addiction; 19. Pregnant or lactating women; 20. The adverse reactions from previous anti-tumor treatments have not yet recovered to grade 1 (except for hair loss); 21. The investigator has determined that the patient has a severe uncontrollable disease, or there are other circumstances that may affect the ability to receive the treatment in this study, and it is considered unsuitable for participation in this study; 22. Other situations where the researcher deems the patient is not eligible for inclusion in the study.

研究实施时间：

Study execute time：

从 From 2026-01-31 00:00:00至 To 2026-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-31 00:00:00 至 To 2026-12-29 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

24

Group：

Experimental group

Sample size：

干预措施：

VSV-01 及 OVV-00 的体积根据肿瘤病灶大小确定，根据指南尽量给至最大体积。研究者在每次注射前 24 h 内评价受试者注射病灶的大小，以确定研究药物的注射体积。每例受试者每个给药日的所有病灶总注射量不超过 10 mL。

干预措施代码：

Intervention：

The volumes of VSV-01 and OVV-00 are determined based on the size of the tumor lesion. According to the guidelines, the maximum volume is given. The researchers evaluate the size of the injection lesion of the subjects 24 hours before each injection to determine the injection volume of the study drug. The total injection volume for all lesions of each subject on each dosing day does not exceed 10 mL.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河南省 

市(区县)：

  

Country：

China 

Province：

Henan 

City：

 

单位(医院)：

新乡医学院第一附属医院 

单位级别：

三级甲等 

Institution
hospital：

The First Affiliated Hospital of Xinxiang Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

剂量限制性毒性

指标类型：

主要指标

Outcome：

Dose Limiting Toxicity

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：

尿液

组织：

Sample Name：

Urine

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：

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：

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:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

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：

EDC

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

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-01-29 09:44:46