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A Single-center, Single-arm, Exploratory Phase II Clinical Trial of Irreversible Electroporation Combined with First-line Chemotherapy for Pancreatic Cancer with Liver Oligometastases

A Single-center, Single-arm, Exploratory Phase II Clinical Trial of Irreversible Electroporation Combined with First-line Chemotherapy for Pancreatic Cancer with Liver Oligometastases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600115939
Enrollment
Unknown
Registered
2026-01-04
Start date
2026-01-04
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

Experimental Group:Irreversible Electroporation Ablation Combined with Chemotherapy

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients who have received at least two courses of chemotherapy, have been evaluated as Stable disease (SD), Partial response or Complete response after imaging examination, and simultaneously meet the following criteria can be enrolled in the trial: 1) Age: 18 to 80 years old, gender not limited. 2) It was clearly diagnosed as primary pancreatic ductal adenocarcinoma by histology or cytology, and clinically diagnosed as liver metastasis of pancreatic cancer. 3) The diameter of the primary pancreatic tumor is no more than 5cm, and the number of intrahepatic metastatic lesions is no more than 5, with the maximum diameter of a single lesion being no more than 3cm. 4) Those who have not received local ablation treatment before; 7 5)Karnofsky Physical Strength Score (KPS) >=80 or ECOG 0-1 points; 6) Those who voluntarily participate and sign the informed consent form, undergo examinations and regular follow-ups as stipulated in the plan, and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1) Expected survival time <= 6 months. 2) History of prior local ablation therapy. 3) Presence of severe complications, such as active massive gastrointestinal bleeding, perforation, or intestinal obstruction. 4) Tumor invasion of the stomach wall or duodenum. 5) History of severe arrhythmia, coronary heart disease, sick sinus syndrome, or recent occurrence of extensive myocardial infarction; or implantation of a permanent cardiac pacemaker or other metal implants. 6) Presence of metal stents or other metal implants within 2.5 cm of the ablation area. 7) Severe cardiac, pulmonary, or renal insufficiency, or inability to tolerate general anesthesia. 8) Use of anticoagulant medications within one week prior to the procedure or abnormal coagulation function. 9) Acute infection or acute exacerbation of a chronic infection. 10) Pregnant or lactating women, or women of childbearing potential who refuse to use appropriate contraception. 11) History of epilepsy, psychiatric disorders, or mental illness that may affect the understanding of informed consent or the implementation of the trial protocol. 12) Judged by the investigator as unsuitable for enrollment or unwilling to accept potential surgical intervention.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Overall survival;Quality of Life (QoL) Assessment in Cancer Patients;Rate of Perioperative Complication;Perioperative Mortality;

Countries

China

Contacts

Public ContactShengping Li

Sun Yat-sen University Cancer Center

lishengp@mail.sysu.edu.cn+86 139 2275 5669

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026