ChiCTR2600124856 版本V1.0 版本创建时间2026/05/18 17:05:08 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：

 ChiCTR2600124856 

最近更新日期：

Date of Last Refreshed on：

 2026-05-18 17:05:00 

注册时间：

Date of Registration：

 2026-05-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

SynOV1.1腺病毒注射液治疗高甲胎蛋白实体瘤的临床研究

Public title：

Clinical study of SynOV1.1 adenovirus injection for the treatment of solid tumors with high alpha-fetoprotein levels

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价SynOV1.1腺病毒注射液在甲胎蛋白高表达的实体肿瘤患者中的安全性、耐受性和抗肿瘤活性的探索性临床研究

Scientific title：

An exploratory clinical study evaluating the safety, tolerability, and antitumor activity of SynOV1.1 adenovirus injection in patients with alpha-fetoprotein-overexpressing 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：

韩彦杰 

研究负责人：

李宁 

Applicant：

Yanjie Han 

Study leader：

Ning Li 

申请注册联系人电话：

Applicant telephone：

 +86 10 67781331

研究负责人电话：

Study leader's
telephone：

+86 10 8778 8165

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：

 annyhan_1997@163.com

研究负责人电子邮件：

Study leader's E-mail：

 lining@cicams.ac.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：

北京市朝阳区潘家园南里17 号

研究负责人通讯地址：

北京市朝阳区潘家园南里17 号

Applicant address：

No. 17, Panjiayuan South Lane, Chaoyang District, Beijing

Study leader's address：

No. 17, Panjiayuan South Lane, Chaoyang District, Beijing

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：

中国医学科学院肿瘤医院

Applicant's institution：

Cancer Hospital Chinese Academy of Medical Sciences

研究负责人所在单位：

中国医学科学院肿瘤医院廊坊院区

Affiliation of the Leader：

Langfang Campus of Chinese Academy of Medical Sciences 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：

 26/086-0411

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：

中国医学科学院肿瘤医院廊坊院区伦理委员会

Name of the ethic committee：

The Ethics Committee of Lang fang Campus of Cancer Hospital, Chinese Academy of Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-28 00:00:00

伦理委员会联系人：

贾硕鹏

Contact Name of the ethic committee：

Jia ShuoPeng

伦理委员会联系地址：

北京市朝阳区潘家园南里17 号

Contact Address of the ethic committee：

No. 17, Panjiayuan South Lane, Chaoyang District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 316 5918495

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 3319091412@stu.cpu.edu.cn

研究实施负责（组长）单位：

中国医学科学院肿瘤医院廊坊院区

Primary sponsor：

Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital

研究实施负责（组长）单位地址：

北京市朝阳区潘家园南里17 号

Primary sponsor's address：

No. 17, Panjiayuan South Lane, Chaoyang District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

河北省

市(区县)：

Country：

China

Province：

Hebei

City：

单位(医院)：

中国医学科学院肿瘤医院廊坊院区

具体地址：

北京市朝阳区潘家园南里17 号

Institution
hospital：

Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital

Address：

No. 17, Panjiayuan South Lane, Chaoyang District, Beijing

经费或物资来源：

临床研究专项预算

Source(s) of funding：

Clinical research special budget

研究疾病：

甲胎蛋白高表达的实体肿瘤  

Target disease：

Solid tumors with high alpha-fetoprotein expression

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：

评价SynOV1.1腺病毒注射液（简称SynOV1.1）在甲胎蛋白高表达的实体肿瘤患者中的安全性、耐受性和抗肿瘤疗效。  

Objectives of Study：

To evaluate the safety, tolerability, and antitumor efficacy of SynOV1.1 adenovirus injection (SynOV1.1) in patients with solid tumors exhibiting high alpha-fetoprotein expression.

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. 自愿参加临床研究；完全了解、知情本研究；愿意遵循并有能力完成试验程序。 2. 年龄 18~80（含）周岁。 3. 临床判断 AFP 阳性（AFP > 20 μg/L）的实体肿瘤患者。 4. 至少有一个可直接注射或通过影像学引导实时瘤内注射的病灶，影像学检查三相 CT 扫描或动态对照增强核磁共振图像显示：10 mm <= 最长径 <= 50 mm。 5. 用药前 1 周 ECOG 评分 0~1 分。 6. 预计生存时间 >= 12 周。 7. 有充分的器官功能： (1) 血液系统：中性粒细胞绝对值（ANC）>= 1.5 x 10^9/L；血小板（PLT）>= 60 x 10^9/L；血红蛋白（Hb）>= 90 g/L。 (2) 肝功能：总胆红素（TBIL）<= 1.5 x ULN；丙氨酸氨基转移酶（ALT）<= 3 x ULN；天门冬氨酸氨基转移酶（AST）<= 3 x ULN；白蛋白 >= 2.8 g/dL。 (3) 肾功能：肌酐 <= 1.5 x ULN；或肌酐清除率（Ccr）>= 50 mL/min（根据 Cockcroft-Gault 公式计算，仅在肌酐 > 1.5 x ULN 时计算 Ccr）。 (4) 凝血功能：活化部分凝血活酶时间（aPTT）<= 1.5 x ULN；国际标准化比值（INR）或凝血酶原时间（PT）<= 1.5 x ULN。 (5) 甲状腺功能：促甲状腺素（TSH）<= 3 x ULN；游离甲状腺素（FT3/FT4）<= 1 x ULN。 (6) Child-Pugh 肝功能评分为 A 级或较好的 B 级（<= 7 分）。 8. 女性患者具有绝经后状态的证据，或者绝经前女性患者的血清妊娠检查结果为阴性。 9. 有生育能力的合格受试者（男性和女性）必须同意在试验期间和末次用药后至少 90 天内与其伴侣一起使用有效节育措施（激素或屏障法或禁欲）。

Inclusion criteria

1. Voluntary participation in clinical research; Fully informed and informed of this study; Willing to follow and able to complete trial procedures. 2. Age 18~80 (inclusive) years old. 3. Patients with solid tumors with clinical judgment that is AFP positive (AFP > 20 μg/L). 4. At least one lesion that can be injected directly or by imaging-guided real-time intratumoral injection with imaging examination three-phase CT scan or dynamic control enhanced MRI image revealing: 10 mm <= longest diameter <= 50 mm. 5. ECOG score of 0~1 point 1 week before medication. 6. Expected survival time >= 12 weeks. 7. Have adequate organ function: (1) Hematological system: absolute neutrophil value (ANC) > = 1.5 x 10^9/L; Platelets (PLT)> = 60 x 10^9/L; Hemoglobin (Hb)> = 90 g/L. (2) Liver function: total bilirubin (TBIL) <= 1.5 x ULN; Alanine aminotransferase (ALT) <= 3 x ULN; Aspartate aminotransferase (AST) <= 3 x ULN; Albumin >= 2.8 g/dL. (3) Renal function: creatinine <= 1.5 x ULN; or creatinine clearance (Ccr) >= 50 mL/min (calculated according to the Cockcroft-Gault formula, Ccr calculated only when creatinine > 1.5 x ULN). (4) Coagulation function: activated partial thromboplastin time (aPTT) <= 1.5 x ULN; International normalized ratio (INR) or prothrombin time (PT) <= 1.5 x ULN. (5) Thyroid function: thyroid-stimulating hormone (TSH)<= 3 x ULN; Free thyroxine (FT3/FT4) < = 1 x ULN. (6) Child-Pugh liver function score of grade A or better grade B (<= 7 points). 8. Evidence of postmenopausal status in female patients or negative serum pregnancy test in premenopausal female patients. 9. Eligible subjects of childbearing potential (male and female) must agree to use effective birth control (hormonal or barrier method or abstinence) with their partner during the trial and for at least 90 days after the last dose.

排除标准：

1.在首次使用研究药物前3周或至少5个药物半衰期（以时间较短者为准）内接受过任何系统性抗肿瘤治疗，包括但不限于化疗、生物治疗、免疫治疗、靶向治疗或激素治疗等；以及在首次使用研究药物前4周内接受过任何针对靶病灶的局部治疗或手术，包括经乙醇注射、射频消融、经动脉化疗栓塞、肝动脉内化疗等。
2.在首次使用研究药物前14天内接受过全身使用的糖皮质激素（强的松＞10mg/天或等价剂量的同类药物）或其他免疫抑制剂治疗；除外以下情况：使用局部、眼部、关节腔内、鼻内和吸入型糖皮质激素治疗；短期使用糖皮质激素进行预防治疗（如预防造影剂过敏）。
3.在首次使用研究药物前14天内使用过免疫调节药物，包括但不限于胸腺肽、白介素-2、干扰素等。
4.在首次使用研究药物前4周内使用过减毒活疫苗，包括但不限于：麻疹、腮腺炎、风疹、水痘/带状疱疹、黄热病、狂犬病、卡介苗和伤寒疫苗。注射用季节性流感疫苗为灭活病毒疫苗，因此允许使用；鼻内用流感疫苗为减毒或疫苗，则不允许使用。
5.在首次使用研究药物前4周内接受过其它未上市的临床研究药物治疗。
6.同时入组于另一项临床研究，观察性（非干预性）临床研究或干预性研究的随访阶段除外。
7.在首次使用研究药物前4周内接受过主要脏器外科手术（不包括穿刺活检）或出现过显著外伤，或需要在试验期间接受择期手术。
8.既往抗肿瘤治疗的不良反应尚未恢复到NCI-CTCAE V5.0等级评价≤1级（脱发等研究者判断无安全风险的毒性除外）。
9.具有临床症状的中枢神经系统转移或脑膜转移，或有其他证据表明患者中枢神经系统转移或脑膜转移灶尚未控制，经研究者判断不适合入组，临床症状怀疑有脑或脑膜疾病的患者需要CT/MRI检查予以排除。 既往接受过治疗的脑转移患者，如果在入组前4周内临床情况稳定并且没有发生新病灶或病灶扩大的证据，并且在首次给药前7天内没有接受类固醇治疗，则可考虑入组。
10.具有软脑膜疾病病史。
11.有证据显示存在未控制的严重合并症，该合并症可能会影响患者对研究方案的依从性，包括严重肝脏疾病（如严重的食管胃底静脉曲张需要介入治疗、肝性脑病、或上腔静脉综合征）。
12.有严重的心血管疾病史，包括但不限于： 有严重的心脏节律或传导异常，如需要临床干预的室性心律失常、Ⅱ-Ⅲ度房室传导阻滞，QTc间期≥480ms等； 首次给药前6个月内发生急性冠脉综合征、急性心肌梗死、充血性心力衰竭、脑卒中或其他3级及以上心血管事件； 美国纽约心脏病协会（NYHA）心功能分级≥II级或左室射血分数（LVEF）＜50％； 经研究者判断具有严重的高血压，在溶瘤病毒注射前48小时和注射后48小时都不能停止使用降压药物治疗。
13.临床无法控制的第三间隙积液，经研究者判断不适合入组。
14.已知的肺结核感染病史或有免疫缺陷病史，包括人类免疫缺陷病毒（HIV）抗体检测阳性。
15.已知对SynOV1.1或抗PD-1抗体处方中任何组分存在过敏反应者。
16.患有已知的可能影响试验依从性的精神疾病障碍或药物滥用疾病。
17.妊娠期或哺乳期女性或者计划在本试验期间妊娠或哺乳的患者。
18.研究者认为受试者存在其他原因而不适合参加本临床研究，包括但不限于肿瘤主要血管结构、巨大肿瘤、肿瘤负荷＞50%肝脏体积和/或侵入下腔静脉、肿瘤与重要神经血管结构、气道相邻或肿瘤位于具有不良事件高风险或不适合瘤内注射位置、具有增强CT/核磁检查禁忌症。
19.研究者评价认为首次给药前1个月内有显著出血事件发生使得瘤内注射程序风险增高。
20.SynOV1.1瘤内注射治疗前无法停用抗凝血或抗血小板药物治疗，包括： a）SynOV1.1瘤内注射前7天内无法停用阿司匹林； b）SynOV1.1瘤内注射前7天内无法停用可密定； c）SynOV1.1瘤内注射前>24小时内无法停用低分子量肝素（LMWH）； d）SynOV1.1瘤内注射前>4小时内无法停用普通肝素（UFH）； e）SynOV1.1瘤内注射前4天内无法停用口服直接凝血酶抑制剂（达比加群）或直接Xa因子抑制剂（利伐沙班、阿哌沙班和依度沙班）。注意：上述抗凝血药物疗法转换患者SynOV1.1治疗前可间断使用LMWH或UFH进行治疗（如治疗医师认为合适），但LWMH末次治疗距研究治疗至少应>24小时，UFH末次治疗距研究治疗至少应>4小时。
21.需要全身性治疗的活动性感染。
22.正在发作需要药物治疗的严重炎性皮肤疾病或需要药物治疗的严重湿疹史。
23.曾接受过或计划接受器官移植（如肝移植）的患者。
24.已知有另外一种肿瘤，目前正在进展，或过去5年内曾需要积极的治疗。但不包括下述：已接受可能治愈性治疗的皮肤基底细胞或鳞状上皮细胞癌、原位癌（例如乳腺癌，原位宫颈癌）。

Exclusion criteria：

1.Patients must have received any systemic anti-tumor therapy, including but not limited to chemotherapy, biotherapy, immunotherapy, targeted therapy, or hormone therapy, within 3 weeks or at least 5 drug half-lives (whichever is shorter) prior to the first use of the investigational drug; and patients must have received any local treatment or surgery targeting the lesion, including ethanol injection, radiofrequency ablation, transarterial chemoembolization, or intrahepatic artery chemotherapy, within 4 weeks prior to the first use of the investigational drug.
2.Patients who have received systemic glucocorticoids (prednisone >10 mg/day or equivalent dose of the same drug) or other immunosuppressants within 14 days prior to the first use of the study drug; excluding the following: use of topical, ocular, intra-articular, intranasal, and inhaled glucocorticoids; short-term use of glucocorticoids for prophylactic treatment (e.g., for contrast agent allergy prevention).
3.Patients who have used immunomodulatory drugs, including but not limited to thymosin, interleukin-2, and interferon, within 14 days prior to their first use of the investigational drug.
4.Administered live attenuated vaccines within 4 weeks prior to the first use of the investigational drug, including but not limited to: measles, mumps, rubella, varicella/shingles, yellow fever, rabies, BCG, and typhoid vaccines. Injectable seasonal influenza vaccines are inactivated virus vaccines and are therefore permitted; intranasal influenza vaccines are live attenuated or non-live attenuated vaccines and are not permitted.
5.The patient had received treatment with other unmarketed investigational drugs within 4 weeks prior to the first use of the investigational drug.
6.Simultaneous enrollment in another clinical study, except for the follow-up phase of an observational (non-interventional) clinical study or an interventional study.
7.Those who have undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to the first use of the investigational drug, or who need to undergo elective surgery during the trial.
8.Adverse reactions to previous antitumor treatments have not recovered to grade 1 (≤1 in NCI-CTCAE V5.0 rating, excluding toxicities such as hair loss that researchers judged to pose no safety risk).
9.Patients with clinically symptomatic central nervous system or meningeal metastases, or other evidence indicating that these metastases are uncontrolled, and deemed unsuitable for enrollment by the investigator, or whose clinical symptoms suggest brain or meningeal disease, require CT/MRI examination for exclusion. Patients with previously treated brain metastases who are clinically stable for 4 weeks prior to enrollment and have no evidence of new lesions or lesion enlargement, and who have not received steroid treatment within 7 days prior to the first dose, may be considered for enrollment.
10.Has a history of leptomeningeal disease.
11.There is evidence of uncontrolled serious comorbidities that could affect patient adherence to the study protocol, including serious liver disease (such as severe esophageal and gastric varices requiring intervention, hepatic encephalopathy, or superior vena cava syndrome).
12.A history of severe cardiovascular disease, including but not limited to: severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, QTc interval ≥480 ms, etc.; occurrence of acute coronary syndrome, acute myocardial infarction, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events within 6 months prior to the first dose; New York Heart Association (NYHA) functional class ≥II or left ventricular ejection fraction (LVEF) <50%; severe hypertension as determined by the investigator, requiring continued use of antihypertensive medication for 48 hours before and after oncolytic virus injection.
13.Those with uncontrollable third-space effusion were deemed unsuitable for enrollment by the researchers.
14.A known history of tuberculosis infection or immunodeficiency, including a positive test for human immunodeficiency virus (HIV) antibodies.
15.Individuals with a known allergic reaction to any component of the SynOV1.1 or anti-PD-1 antibody prescription.
16.Suffering from a known mental disorder or substance abuse disorder that may affect trial compliance.
17.Women who are pregnant or breastfeeding, or patients who plan to become pregnant or breastfeed during this trial.
18.The researchers believe that the subjects are unsuitable to participate in this clinical study for other reasons, including but not limited to major vascular structures of the tumor, large tumors, tumor burden >50% of liver volume and/or invasion of the inferior vena cava, tumors adjacent to important neurovascular structures, tumors located in areas with high risk of adverse events or unsuitable for intratumoral injection, and contraindications to enhanced CT/MRI scans.
19.Researchers believe that significant bleeding events occurring within one month prior to the first dose increase the risk of intratumoral injection procedures.
20.Anticoagulant or antiplatelet therapy cannot be discontinued before intratumoral injection of SynOV1.1, including: a) Aspirin cannot be discontinued within 7 days prior to intratumoral injection of SynOV1.1; b) Cormidin cannot be discontinued within 7 days prior to intratumoral injection of SynOV1.1; c) Low molecular weight heparin (LMWH) cannot be discontinued within >24 hours prior to intratumoral injection of SynOV1.1; d) Unfractionated heparin (UFH) cannot be discontinued within >4 hours prior to intratumoral injection of SynOV1.1; e) Oral direct thrombin inhibitors (dabigatran) or direct factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban) cannot be discontinued within 4 days prior to intratumoral injection of SynOV1.1. Note: Patients switching to SynOV1.1 therapy may use LMWH or UFH intermittently before treatment (if deemed appropriate by the treating physician), but the last LWMH treatment should be at least >24 hours after the study treatment, and the last UFH treatment should be at least >4 hours after the study treatment.
21.Active infection requiring systemic treatment.
22.A history of a severe inflammatory skin condition requiring medication or severe eczema requiring medication.
23.Patients who have received or plan to receive organ transplants (such as liver transplants).
24.There is a known presence of another tumor that is currently progressing, or that has required aggressive treatment within the past 5 years. However, this does not include the following: basal cell or squamous cell carcinoma of the skin that has received potentially curative treatment, or carcinoma in situ (e.g., breast cancer, cervical cancer in situ).

研究实施时间：

Study execute time：

从 From 2026-06-01 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2028-12-31 00:00:00

干预措施：

Interventions：

组别：

队列B

样本量：

 9

Group：

group B

Sample size：

干预措施：

SynOV1.1联合PD-1/VEGF抗体

干预措施代码：

Intervention：

SynOV1.1 combined with PD-1/VEGF antibody

Intervention code：

组别：

队列A

样本量：

 9

Group：

group A

Sample size：

干预措施：

SynOV1.1

干预措施代码：

Intervention：

SynOV1.1

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北省 

市(区县)：

  

Country：

China

Province：

Hebei

City：

单位(医院)：

 中国医学科学院肿瘤医院廊坊院区 

单位级别：

 三级甲等 

Institution
hospital：

Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

DLT的发生频率

指标类型：

主要指标

Outcome：

The frequency of DLT occurrence

Type：

Primary indicator

测量时间点：

测量方法：

按照国际通用的CTCAE v6.0 毒性评价标准进行判断

Measure time point of outcome：

Measure method：

Assessments are made in accordance with the internationally recognized CTCAE v6.0 toxicity evaluation criteria

指标中文名：

注射病灶肿瘤大小

指标类型：

次要指标

Outcome：

Injection lesion tumor size

Type：

Secondary indicator

测量时间点：

完成第4次治疗后21天

测量方法：

按照RECIST，mRECIST标准进行评估

Measure time point of outcome：

21 days after completing the 4th treatment

Measure method：

Assessed according to RECIST and mRECIST criteria.

指标中文名：

不良事件（AE）

指标类型：

主要指标

Outcome：

Adverse Event (AE)

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：

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：

肿瘤组织

组织：

Sample Name：

tumor tissue

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 80 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)：

NA

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：

有/Yes

注册人：

Name of Registration：

  2026-05-18 17:05:00