简体中文|English
Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

The efficacy and safety of multimodal ablation combined with NALIRIFOX and adalimumab as first-line treatment for pancreatic cancer with liver metastasis: A prospective single-arm study.

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注册号：

Registration number：

ChiCTR2600124854 

最近更新日期：

Date of Last Refreshed on：

2026-05-18 16:58:42 

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：

多模态消融联合 NALIRIFOX 及阿得贝利单抗一线治疗胰腺癌伴肝转移的有效性和安全性：一项前瞻性单臂研究

Public title：

The efficacy and safety of multimodal ablation combined with NALIRIFOX and adalimumab as first-line treatment for pancreatic cancer with liver metastasis: A prospective single-arm study.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

多模态消融联合 NALIRIFOX 及阿得贝利单抗一线治疗胰腺癌伴肝转移的有效性和安全性：一项前瞻性单臂研究

Scientific title：

The efficacy and safety of multimodal ablation combined with NALIRIFOX and adalimumab as first-line treatment for pancreatic cancer with liver metastasis: A prospective single-arm study.

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：

金仁安 

研究负责人：

梁霄 

Applicant：

Renan Jin 

Study leader：

Xiao Liang  

申请注册联系人电话：

Applicant telephone：

+86 18888888888

研究负责人电话：

Study leader's telephone：

+86 13588708506

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：

jason198508@126.com

研究负责人电子邮件：

Study leader's E-mail：

srrshlx@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：

浙江省杭州市上城区庆春东路3号

研究负责人通讯地址：

浙江省杭州市上城区庆春东路3号

Applicant address：

No. 3, Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province

Study leader's address：

No. 3, Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang 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：

浙江大学医学院附属邵逸夫医院

Applicant's institution：

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

研究负责人所在单位：

浙江大学医学院附属邵逸夫医院

Affiliation of the Leader：

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang 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：

邵逸夫医院伦审2025研第0670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：

浙江大学医学院附属邵逸夫医院医学伦理委员会

Name of the ethic committee：

Ethics Committee,Sir Run Run Shaw Hospital,Zhejiang University School of Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025-09-17 00:00:00

伦理委员会联系人：

杨漾池

Contact Name of the ethic committee：

Yangchi Yang

伦理委员会联系地址：

浙江省杭州市上城区庆春东路3号

Contact Address of the ethic committee：

No. 3, Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 571 86006811

伦理委员会联系人邮箱：

Contact email of the ethic committee：

yyc261@foxmail.com

研究实施负责（组长）单位：

浙江大学医学院附属邵逸夫医院

Primary sponsor：

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

研究实施负责（组长）单位地址：

浙江省杭州市上城区庆春东路3号

Primary sponsor's address：

No. 3, Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang 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)：

浙江省

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

浙江大学医学院附属邵逸夫医院

具体地址：

浙江省杭州市上城区庆春东路3号

Institution
hospital：

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Address：

No. 3, Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Elective Course (Self-Funded)

Target disease：

Pancreatic cancer with liver metastasis

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：

本研究旨在评价多模态消融联合 NARILIFOX 化疗方案以及阿得贝利单抗治疗胰腺癌伴肝转移的有效性和安全性，通过观察患者的临床疗效，并且探索性观察免疫指标的变化，明确该联合治疗模式在胰腺癌伴肝转移治疗中的应用价值。  

Objectives of Study：

This study aims to evaluate the efficacy and safety of multimodal ablation combined with the NARILIFOX chemotherapy regimen and adibelimab in the treatment of pancreatic cancer with liver metastasis. By observing the clinical efficacy of patients and exploring the changes in immune indicators, the application value of this combined treatment mode in the treatment of pancreatic cancer with liver metastasis will be clarified.

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 周岁; 2.组织病理学或细胞学证实且未经治疗的胰腺癌伴肝转移患者，无肝脏以外其它器官转移; 3.肝脏多发转移，肝脏转移灶最大径<=5 cm，至少有一个适合消融的转移灶且最大径<=3 cm; 4.胰腺原发灶或者至少有一个肝脏转移灶可在 CT/MRI 上测量（RECIST V 1.1）; 5.ECOG PS 0-1 分; 6.预期生存期>=3 个月; 7.血常规、生化及主要脏器功能的纳入标准： (1)骨髓功能：中性粒细胞绝对计数>=2.0×10^9/L，血小板计数>=100×10^9/L，血红蛋白>=90g/L； (2)肝功能：定义为总胆红素水平<=1.5 倍正常上限（ULN），如有梗阻性黄疸者允许先行胆道引流，行胆道引流者胆红素水平<=3.0 倍正常上限（ULN）；谷草转氨酶（AST）和谷丙转氨酶（ALT）水平<=5 倍 ULN； (3)肾功能：定义为血清肌酐<=1.5 倍ULN；尿常规检查尿蛋白少于 2+，若患者在基线水平的尿蛋白>=2+时应收集 24h 尿液并证明 24h 尿蛋白定量检测<=1g； (4)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；若患者正接受抗凝治疗，只要 PT 在抗凝药物拟定使用范围内即可。 8.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）前 7 天内呈尿液或血清妊娠试验阴性。若尿液妊娠试验结果无法确认为阴性，则要求其进行血液妊娠试验；对于男性，须同意在试验期间和末次给予试验药物后 8 周内采用适当的方法避孕或已手术绝育。 9.自愿参加本研究，并且签署知情同意书。若受试者因无行为能力等原因不能阅读和签署知情同意书的，则需由其监护人代理知情过程并签署知情同意书。若受试者无阅读知情同意书能力（如文盲受试者），则需由见证人见证知情过程并签署知情同意书。

Inclusion criteria

1. Age >= 18 years; 2. Patients with pathologically or cytologically confirmed untreated pancreatic cancer with liver metastasis, without metastasis to other organs outside the liver; 3. Multiple liver metastases, with the largest liver metastatic lesion <= 5 cm, and at least one metastasis suitable for ablation with the largest diameter <= 3 cm; 4. The primary pancreatic lesion or at least one liver metastasis can be measured on CT/MRI (RECIST V 1.1); 5. ECOG PS 0-1 score; 6. Expected survival >= 3 months; 7. Inclusion criteria for blood routine, biochemistry and main organ functions: (1) Bone marrow function: absolute neutrophil count >=2.0×10^9/L, platelet count >=100×10^9/L, hemoglobin >=90g/L; (2) Liver function: defined as total bilirubin level <=1.5 times the upper limit of normal (ULN), if there is obstructive jaundice, biliary drainage is allowed first, and bilirubin level <=3.0 times the upper limit of normal (ULN) for those who undergo biliary drainage; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <=5 times ULN; (3) Renal function: defined as serum creatinine <=1.5 times ULN; If the patient has a baseline level of urine protein >=2, 24h urine should be collected and the 24h urine protein quantitative test should be proved to be <=1g; (4) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; If the patient is receiving anticoagulant therapy, PT is within the intended range of anticoagulant use. 8. For female subjects of childbearing potential, a negative urine or serum pregnancy test should be present within 7 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required; For men, agree to use an adequate method of contraception or surgical sterilization during the trial and for 8 weeks after the last dose of study drug. 9. Volunteer to participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity or other reasons, his guardian must act as an agent for the informed consent process and sign the informed consent form. If the subject does not have the ability to read the informed consent form (e.g., illiterate subjects), the informed consent process must be witnessed by a witness and the informed consent form must be signed.

排除标准：

1.既往接受过针对当前疾病的放疗、介入、射频消融、手术、化疗、免疫、靶向或者其他研究性治疗。 2.对本研究相关治疗药物过敏。 3.正在参与其他干预性临床研究治疗。 4.首次给药前 5 年内诊断为胰腺癌以外的其他恶性疾病（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）。 5.既往接受过下列疗法：抗 PD-1、抗 PD-L1 或抗 PD-L2 相关药物或针对另一种刺激或协同抑制 T 细胞受体（如：CTLA-4、OX-40、CD137）的药物。 6.接受过实体脏器或血液系统移植。 7.在入组前14天内曾罹患过需要使用皮质类固醇（泼尼松或等效药物的日剂量＞10 mg）或其他免疫抑制药物进行全身治疗的任何疾病。 8.活动性自身免疫性疾病或可能复发的自身免疫性疾病病史。 9.筛选期进行的胸部 CT 扫描存在特发性肺纤维化、器质性肺炎（如闭塞性细支气管炎）或非感染性肺炎病史的证据。 10.入组前 4 周内出现过严重感染（包括但不限于：因感染并发症、菌血症或严重肺炎住院治疗）。 11.入组前 14 天内需接受全身性（口服或静脉注射）抗生素治疗的严重慢性或活动性感染（包括肺结核感染等）。 12.已知有人类免疫缺陷病毒（HIV）感染史（即 HIV 1/2 抗体阳性）。 13.达到以下任何心血管疾病标准。 (1)开始研究治疗前 3 个月之内发生包括纽约心脏病学会心脏疾病（II 级或者更高）。 (2)开始研究治疗前 6 个月之内发生心肌炎、心肌梗死或脑血管事件在内的重大心血管疾病、不稳定性心律失常或不稳定性心绞痛。 (3)入组之前<=6 个月之内曾出现症状性肺栓塞。 (4)已知有冠状动脉疾病或左心室射血分数（LVEF）＜40%的患者。 14.哺乳期妇女。 15.育龄期妇女且不愿意避孕。 16.除老年人/文盲外之外的弱势群体，包括：精神疾病者、认知损伤者、危重患者等。 17.其他任何理由，研究者认为不合适参加本研究者。

Exclusion criteria：

1. Previously received radiotherapy, interventional therapy, radiofrequency ablation, surgery, chemotherapy, immunotherapy, targeted therapy, or other investigational treatments for the current disease. 2. Allergic to drugs related to this study. 3. Currently participating in other interventional clinical research treatments. 4. Diagnosed with malignant diseases other than pancreatic cancer within 5 years prior to the first administration (excluding completely resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or completely resected carcinoma in situ). 5. Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 related drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (such as CTLA-4, OX-40, CD137). 6. Have received a solid organ or hematopoietic system transplant. 7. Any disease within 14 days prior to enrollment that required systemic treatment with corticosteroids (prednisone or equivalent medication at a daily dose >10 mg) or other immunosuppressive drugs. 8. Active autoimmune disease or history of autoimmune disease that may relapse. 9. Evidence in chest CT during the screening period of idiopathic pulmonary fibrosis, organic pneumonia (such as obliterative bronchiolitis), or a history of non-infectious pneumonia. 10. Severe infection within 4 weeks prior to enrollment (including but not limited to hospitalization for infection complications, sepsis, or severe pneumonia). 11. Severe chronic or active infection requiring systemic (oral or intravenous) antibiotic treatment within 14 days prior to enrollment (including tuberculosis infection, etc.). 12. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive). 13. Meeting any of the following cardiovascular disease criteria: (1) Occurrence of New York Heart Association (NYHA) class II or higher heart disease within 3 months prior to starting study treatment. (2) Occurrence of major cardiovascular disease within 6 months prior to starting study treatment, including myocarditis, myocardial infarction, or cerebrovascular events, unstable arrhythmia, or unstable angina. (3) Symptomatic pulmonary embolism within ≤6 months prior to enrollment. (4) Known coronary artery disease or patients with left ventricular ejection fraction (LVEF) <40%. 14. Breastfeeding women. 15. Women of childbearing potential who are unwilling to use contraception. 16. Vulnerable populations other than the elderly/illiterate, including those with mental illness, cognitive impairment, critically ill patients, etc. 17. Any other reason the investigator deems the participant unsuitable for this study.

研究实施时间：

Study execute time：

从 From 2026-05-01 00:00:00至 To 2028-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-05-18 00:00:00 至 To 2028-09-30 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

19

Group：

Experimental Group

Sample size：

干预措施：

多模态消融联合NARILIFOX化疗及阿得贝利单抗

干预措施代码：

Intervention：

Multimodal ablation combined with NARILIFOX chemotherapy and adbelimab

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China 

Province：

Zhejiang 

City：

 

单位(医院)：

浙江大学医学院附属邵逸夫医院 

单位级别：

三级甲等 

Institution
hospital：

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

客观缓解率

指标类型：

主要指标

Outcome：

ORR,objective response rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

完全缓解

指标类型：

主要指标

Outcome：

CR, complete response

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

部分缓解

指标类型：

主要指标

Outcome：

PR, partial response

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

有效性指标（无进展生存期、总生存期、疾病控制率、缓解持续时间、临床获益率、 6 个月和 12 个月的无进展生存率，6 个月和 12 个月的死亡率）

指标类型：

次要指标

Outcome：

Efficacy indicators (progression-free survival, overall survival, disease control rate, duration of response, clinical benefit rate, progression-free survival at 6 and 12 months, mortality at 6 and 12 months)

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（生命体征、实验室指标、不良事件（AE）、严重不良事件（SAE）、 药物相关性 AE/SAE 及该类药物特定 AE（如高血压、蛋白尿和手足综合征））

指标类型：

次要指标

Outcome：

Safety indicators (vital signs, laboratory indicators, adverse events (AE), serious adverse events (SAE), drug-related AE/SAE, and drug-specific AEs of this type (such as hypertension, proteinuria, and hand-foot syndrome))

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：

穿刺样本

组织：

Sample Name：

Puncture sample

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation 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：

CRF, Resman

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

CRF, Resman

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-05-18 16:58:33
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