中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600116876
最近更新日期： Date of Last Refreshed on：	2026-01-15 18:08:39
注册时间： Date of Registration：	2026-01-15 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	化疗诱导后序贯或不序贯不可逆电穿孔消融术用于局晚期不可切除胰腺癌患者的前瞻性、随机对照、II期临床研究
Public title：	A prospective,randomized controlled phase II clinical study on sequential or non-sequential irreversible electroporation ablation after chemotherapy induction in patients with locally advanced unresectable pancreatic cancer.
注册题目简写：
English Acronym：
研究课题的正式科学名称：	化疗诱导后序贯或不序贯不可逆电穿孔消融术用于局晚期不可切除胰腺癌患者的前瞻性、随机对照、II期临床研究
Scientific title：	A prospective,randomized controlled phase II clinical study on sequential or non-sequential irreversible electroporation ablation after chemotherapy induction in patients with locally advanced unresectable pancreatic 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：	李慧锴	研究负责人：	李慧锴
Applicant：	Li Huikai	Study leader：	Li Huikai
申请注册联系人电话： Applicant telephone：	+86 186 2222 8639	研究负责人电话： Study leader's telephone：	+86 186 2222 8639
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：	YangHonghao@alpmedical.com	研究负责人电子邮件： Study leader's E-mail：	YangHonghao@alpmedical.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：	天津市东丽区东五道1号天津市肿瘤医院空港医院	研究负责人通讯地址：	天津市东丽区东五道1号天津市肿瘤医院空港医院
Applicant address：	No. 1, Dongwu Road, Dongli District, Tianjin City, Tianjin Cancer Hospital Airport Branch	Study leader's address：	No. 1, Dongwu Road, Dongli District, Tianjin City, Tianjin Cancer Hospital Airport Branch
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：	天津市肿瘤医院空港医院
Applicant's institution：	Tianjin Cancer Hospital Airport Hospital
研究负责人所在单位：	天津市肿瘤医院空港医院
Affiliation of the Leader：	Tianjin Cancer Hospital Airport 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：	EC-2025-0272	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：	天津市肿瘤医院空港医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Tianjin Cancer Hospital Airport Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2025-09-26 00:00:00
伦理委员会联系人：	张文丽
Contact Name of the ethic committee：	Zhang Wenli
伦理委员会联系地址：	天津市空港经济特区东五道99号2楼（300308）
Contact Address of the ethic committee：	2nd Floor, No. 99, East Fifth Road, Tianjin Airport Special Economic Zone (300308)
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 189 2028 7608	伦理委员会联系人邮箱： Contact email of the ethic committee：	kgzllunli2021@163.com

研究实施负责（组长）单位：

天津市肿瘤医院空港医院

Primary sponsor：

Tianjin Cancer Hospital Airport Hospital

研究实施负责（组长）单位地址：

天津市东丽区东五道1号天津市肿瘤医院空港医院

Primary sponsor's address：

No. 1, Dongwu Road, Dongli District, Tianjin City, Tianjin Cancer Hospital Airport Branch

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	天津市	市(区县)：
Country：	China	Province：	Tianjin City	City：
单位(医院)：	天津市肿瘤医院空港医院	具体地址：	天津市东丽区东五道1号天津市肿瘤医院空港医院
Institution hospital：	Tianjin Cancer Hospital Airport Hospital	Address：	No. 1, Dongwu Road, Dongli District, Tianjin City, Tianjin Cancer Hospital Airport Branch

经费或物资来源：

天津市肿瘤医院空港医院

Source(s) of funding：

Tianjin Cancer Hospital Airport Hospital

研究疾病：

胰腺癌

Target disease：

Pancreatic 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：

随机平行对照

Study design：

Parallel

研究目的：

主要目的：探索化疗诱导后不可逆电穿孔消融术对于局晚期不可切除胰腺癌患者预后的影响。次要目的：探索不可逆电穿孔消融术的安全性及对患者生活质量的影响。

Objectives of Study：

The main objective was to explore the effect of irreversible electroporation ablation after chemotherapy induction on the prognosis of patients with locally advanced unresectable pancreatic cancer. Secondary objectives were to explore the safety of irreversible electroporation and its effect on quality of life.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Age: 18 to 75 years old, gender not limited;
2. Diagnosed as pancreatic cancer through biopsy and pathological examination of the primary tumor;
3. Voluntarily accept the standard conversion treatment protocol, and after 3 cycles of treatment, the imaging assessment shows non-progression (PR or SD);
4. Locally advanced pancreatic cancer (more than 180° surrounding important blood vessels such as the abdominal trunk, superior mesenteric artery, superior mesenteric vein, and portal vein), which is considered unresectable after MDT discussion;
5. Has not received any palliative chemotherapy (those who have stopped neoadjuvant or adjuvant chemotherapy for more than half a year can be included) or other systemic anti-tumor treatments in the past;
6. According to the evaluation criteria of RECIST version 1.1, it has measurable lesions;
7. The subjects have sufficient organ and bone marrow functions: hemoglobin >=9.0 g/dL; Neutrophil count >=1.5×10^9/L; Platelet count >=100×10^9/L; Total bilirubin (TBIL) <=3×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=5.0×ULN; Serum creatinine <=1.5×ULN or creatinine clearance (CrCl)> 60 mL/min(using the Cockcroft-Gault formula) : For females, CrCl=(140- age)× weight (kg)× 0.85 / (72×Scr mg/dl); for males, CrCl=(140- age)× weight (kg)× 1.00 / (72×Scr mg/dl)
8.ECOG PS score 0-1;
9. Life expectancy is at least 3 months;
10. Patients of childbearing age and their spouses are willing to take contraceptive measures;
11. Voluntarily sign the informed consent form.

排除标准：

1)拒绝接受全身化疗或可能的手术； 2)存在其他部位（如肝、腹膜、肺、骨或脑）转移； 3)有其他恶性肿瘤史者（已治愈的皮肤基底细胞癌及宫颈原位癌除外）； 4)伴有其他的严重疾病，包括但不限于： a)难以控制的充血性心衰（NYHA 分级 III 或 IV，见附件Ⅲ）、不稳定型心绞痛、控制不佳的心律失常、未得到控制的高血压（ SBP>160mmHg 或DBP>100mmHg） b)活动性感染； c)难以控制的糖尿病； d)存在不可控的、需要引流的胸腔积液、心包积液或腹水； e)严重门静脉高压症或影像学表现为门静脉海绵样变； f)胃出口梗阻； g)呼吸功能不全（需要吸氧）； 5)筛选前30天内接受过重大手术； 6)筛选前30天内使用过EGFR单抗或EGFR-TKI； 7)对本方案中使用药物或其成分过敏者； 8)已知的或自诉的HIV感染或慢性乙型肝炎或丙型肝炎史； 9)有任何既往治疗所引起的，尚未消退的CTCAE 2级或以上毒性（不包括贫血、脱发、皮肤色素沉着及化疗诱发的神经毒性）； 10)经研究者判断具有不适合参与本研究的其它原因。

Exclusion criteria：

1) Refuse to undergo systemic chemotherapy or possible surgery; 2) There are metastases in other sites (such as the liver, peritoneum, lungs, bones or brain); 3) Those with a history of other malignant tumors (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 4) Accompanied by other serious diseases, including but not limited to: a) Uncontrollable congestive heart failure (NYHA classification III or IV, see Annex III), unstable angina pectoris, poorly controlled arrhythmia, and uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg) b) Active infection; c) Uncontrolled diabetes; d) There is uncontrollable pleural effusion, pericardial effusion or ascites that requires drainage; e) Severe portal hypertension or imaging manifestations of cavernous changes in the portal vein; f) Gastric outlet obstruction; g) Respiratory insufficiency (requiring oxygen inhalation); 5) Having undergone major surgery within 30 days prior to screening; 6) Have used EGFR monoclonal antibodies or EGFR-Tkis within 30 days prior to screening; 7) Those who are allergic to the drugs or their components used in this plan; 8) Known or self-reported history of HIV infection or chronic hepatitis B or C; 9) There is any unresolved CTCAE grade 2 or above toxicity caused by previous treatments (excluding anemia, alopecia, skin pigmentation and chemotherapy-induced neurotoxicity); 10) There are other reasons that the researcher deems unsuitable for participation in this study.

研究实施时间：

Study execute time：

从 From 2026-01-16 00:00:00至 To 2028-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-01-19 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：	实验组	样本量：	40
Group：	Experimental group	Sample size：	40
干预措施：	计划入组60例符合入选标准且不符合任意排除标准的经化疗诱导3周期后判效为非进展的局晚期胰腺癌患者，所有患者均经MDT讨论认为不可切除，且自愿签署知情同意。进行2:1随机分组，试验组40名患者行开腹不可逆电穿孔消融术，术后继续沿用原有化疗方案，观察其总生存期及无进展生存期等。	干预措施代码：
Intervention：	It is planned to enroll 60 patients with locally advanced pancreatic cancer who meet the inclusion criteria and do not meet any exclusion criteria, and whose disease has been assessed as non-progressing after 3 cycles of chemotherapy induction. All patients have been discussed by the MDT and deemed unresectable, and have voluntarily signed informed consent. Randomization will be conducted in a 2:1 ratio, with 40 patients in the experimental group undergoing open-abdomen irreversible electroporation ablation. After the procedure, the original chemotherapy regimen will be continued, and their overall survival and progression-free survival will be observed.	Intervention code：

组别：	对照组	样本量：	20
Group：	Control group	Sample size：	20
干预措施：	计划入组60例符合入选标准且不符合任意排除标准的经化疗诱导3周期后判效为非进展的局晚期胰腺癌患者，所有患者均经MDT讨论认为不可切除，且自愿签署知情同意。进行2:1随机分组，对照组20名患者沿用原有治疗方案治疗，观察其总生存期及无进展生存期等。	干预措施代码：
Intervention：	It is planned to enroll 60 patients with locally advanced pancreatic cancer who meet the inclusion criteria and do not meet any exclusion criteria, and who have been assessed as non-progressing after 3 cycles of chemotherapy induction. All patients have been discussed by the MDT and deemed unresectable, and have voluntarily signed informed consent. Randomization will be conducted in a 2:1 ratio, with 20 patients in the control group continuing with their original treatment regimen, and their overall survival and progression-free survival will be observed.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	天津市	市(区县)：
Country：	China	Province：	Tianjin City	City：
单位(医院)：	天津市肿瘤医院空港医院	单位级别：	三甲
Institution hospital：	Tianjin Cancer Hospital Airport Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	总生存期（OS）	指标类型：	主要指标
Outcome：	Overall Survival (OS)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无进展生存期（PFS）	指标类型：	主要指标
Outcome：	Progression-free survival (PFS)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	疾病控制率（DCR）	指标类型：	次要指标
Outcome：	Disease control rate (DCR)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	客观缓解率（ORR）	指标类型：	次要指标
Outcome：	Objective response rate (ORR)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	生活质量（QoL）	指标类型：	次要指标
Outcome：	Quality of life (QoL)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	肿瘤标志物	指标类型：	次要指标
Outcome：	Tumor markers	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	术后30天并发症	指标类型：	次要指标
Outcome：	Complications within 30 days after surgery	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	术后30天并发率	指标类型：	次要指标
Outcome：	Postoperative 30-day complication rate	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：	Safety	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：	胰腺	组织：
Sample Name：	Pancreas	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）：

本研究为一项随机对照、干预性临床试验，计划入组60例符合入选标准且不符合任意排除标准的经化疗诱导3周期后判效为非进展的局晚期胰腺癌患者，所有患者均经MDT讨论认为不可切除，且自愿签署知情同意。进行2:1随机分组，40名患者行开腹不可逆电穿孔消融术，术后继续沿用原有化疗方案，20名患者沿用原有治疗方案治疗，观察其总生存期及无进展生存期等。

Randomization Procedure (please state who generates the random number sequence and by what method)：

This study is a randomized, controlled, and interventional clinical trial, with a planned enrollment of 60 patients with locally advanced pancreatic cancer who meet the inclusion criteria and do not meet any exclusion criteria, and have been assessed as non-progressing after 3 cycles of chemotherapy induction. All patients have been discussed by the MDT and deemed unresectable, and have voluntarily signed informed consent. Randomization is conducted in a 2:1 ratio, with 40 patients undergoing open-abdomen irreversible electroporation ablation, and continuing with the original chemotherapy regimen after surgery, while 20 patients continue with the original treatment regimen. The overall survival and progression-free survival are observed.

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：	无
Blinding：	None
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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：	无
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	None
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：	2026-01-15 18:08:34