Phase II/III of Randomized Controlled Clinical Research on IRE Synchronous Chemotherapy for LAPC

• Status: Completed
• Trial end date: 2021-07-30
• Target enrollment: 0
• Participant gender: All

Summary

Previous studies have shown that irreversible electroporation (IRE) preoperative induction chemotherapy or adjuvant chemotherapy after IRE can reduce the local recurrence rate of locally advanced pancreatic cancer (LAPC) and benefit the survival of patients. According to the technical principle of electroporation therapy (EPT), when the cell membrane is electroporated, the resistance of cell membrane decreases instantaneously, which promotes the drug to enter tumor cells and significantly increases its cytotoxicity and killing effect on tumor tissue. The purpose of study is to evaluate the safety and effectiveness of simultaneous gemcitabine administration and IRE for treating LAPC. In order to provide new ideas for the treatment of LAPC.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fuda Cancer Hospital, Guangzhou
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed pancreatic cancer；

• Radiologic confirmation of AJCC stage III locally advanced pancreatic cancer；

• Histological or cytological confirmation of pancreatic adenocarcinoma;

• The maximum diameter of tumor is less than 5 cm；

• Biliary drainage in patients with biliary obstruction；

• PS 0-1

• Written informed consent

Exclusion Criteria:

• Resectable pancreatic adenocarcinoma;

• The tumor invaded the duodenum or stomach through mucosa；

• History of epilepsy;

• History of cardiac disease: congestive heart failure > NYHA classification 2;

• cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker;

• Coronary artery disease and myocardial infarction occurred within 6 months before the screening；

• Uncontrolled hypertension. During screening, blood pressure should be controlled at less than 160/95 mmHg.

• Any implanted metal stent/device within the area of ablation that cannot be removed;

• Any implanted stimulation device;

• Uncontrolled infection (>grade 2 according to NCI CTCAE V4.0);

• Pregnant or lactating women. Women suspected of pregnancy should be tested for pregnancy within 7 days before treatment.

• Allergy to contrast media;

• Compromised liver function: signs of portal hypertension; INR >1.5 without use of anticoagulants; ascites;

• Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study；

• There was a history of chemotherapy within 1 months before screening；

• There was a history of IRE, cryotherapy, microwave therapy, immunotherapy and radiotherapy for pancreatic tumors within the first three months of screening；

• Other primary tumors, except adequately treated non-melanoma skin cancer, cervical carcinoma in situ or other malignant tumors, which did not recur after 5 years of treatment;

• Infection beyond control > Level 2 (NCI-CTC3.0 version);