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Multicenter Clinical Trial of Steep Pulse (irreversible electroporation,IRE) Ablation in Pancreatic Cancer

Multicenter Clinical Trial of Widening the Applied Range of Steep Pulse (IRE)Therapy Instrument in Pancreatic Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060213
Enrollment
Unknown
Registered
2022-05-22
Start date
2022-05-11
Completion date
Unknown
Last updated
2024-04-29

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:Steep pulse (nanoknife) ablation

Sponsors

The First Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 and 80 years old with no gender limitation; 2. Patients with pancreatic malignancy with pathologically confirmed clinical AJCC stage (8th edition) T4NOMO in stage ? and ? (no more than 3 localized lymph node metastases), both newly treated and retreated patients were acceptable; 3. Tumor size (measured by the maximum transverse diameter of preoperative enhanced MRI scan) 50; 6. The subject voluntarily signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe arrhythmias, a history of epilepsy or pacemaker implantation, and patients with recent large-scale myocardial infarction; 2. Patients with severe cardiac, pulmonary or renal insufficiency or who cannot tolerate endotracheal intubation under general anesthesia; 3. Those who are allergic to contrast agents or unable to perform MRI enhanced scanning for other reasons; 4. Patients with hemoglobin = 40 µmol /L; 8. Acute stage of acute infection or chronic infection; 9. Persons with mental abnormality or history of mental illness and unable to cooperate voluntarily; 10. Those who have taken anticoagulant drugs or abnormal coagulation function within 1 week; 11. Pregnant and lactating women and those who plan to become pregnant within one year; 12. Participants in clinical trials of any drugs and/or medical devices within 3 months prior to enrollment; 13. Any other factors that the investigator considers inappropriate for inclusion or that may affect the subjects' participation in the study.

Design outcomes

Primary

MeasureTime frame
The success rate of ablation;The effective rate of ablation;

Secondary

MeasureTime frame
Objective response rates (ORR) at 1, 3 and 6 months after ablation;Clinical benefit rate (CBR) at 6 months after tumor ablation;Time to disease control (DDC) after pancreatic tumor ablation;

Countries

China

Contacts

Public ContactXiao Yueyong

The First Medical Center of Chinese PLA General Hospital

xiaoyueyong@vip.sina.com+86 10 66936197

Outcome results

None listed

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