Locally advanced pancreatic cancer
Conditions
Interventions
Test group:GN chemotherapy+Tegio+IRE ablation
control group:GN chemotherapy+Tegio
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age 18~70 years old, gender unlimited; 2) Patients who need to undergo 4 cycles of induction chemotherapy before enrollment; 3) It is locally advanced pancreatic cancer confirmed by histopathology and/or cytology and according to the clinical American Joint Commission on Cancer staging (8th edition); 4) The size of tumor (measured by the maximum diameter of pre-operative enhanced CT scan) = 5 cm; 5) Before enrollment, the physical strength score of the Eastern Cooperative Oncology Group (ECOG) was = 2 points, and the expected survival period was more than 3 months; 6) The subjects or their legal guardians can understand the purpose of the study, show sufficient compliance with the study protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with distant metastasis after induction chemotherapy; 2) Patients with benign and neuroendocrine tumors; 3) Patients who have previously received targeted treatment, immunotherapy, local ablation, local radiotherapy for LAPC (excluding local radiotherapy for alleviating tumor-related symptoms), surgical treatment (excluding tumor or pathological tissue biopsy and surgical resection not for LAPC); 4) Patients with portal vein system invasion complicated by main portal vein occlusion combined with portal hypertension and massive ascites were enrolled; 5) Patients with cerebrovascular accident, unstable condition of cerebrovascular accident or history of epilepsy within 6 months before enrollment; 6) Implanted with cardiac pacemaker or defibrillator and other stimulators; 7) There are metal stents or other metal implants within 2.5cm from the ablation area; 8) Those who cannot tolerate general anesthesia of tracheal intubation; 9) Uncontrolled complications, including but not limited to persistent or active systemic infection, moderate or severe liver disease or coagulation dysfunction or chronic obstructive pulmonary disease, symptomatic heart failure, unstable angina pectoris, clinically significant arrhythmia or mental illness/social condition, will limit the subject's compliance with the study; 10) Blood and kidney dysfunction with clinical significance (determined by the investigator), unless the investigator can judge that it is caused by pancreatic cancer (the following parameters were not corrected and supported within 2 weeks before assessment): platelet count1.5 times the upper limit of normal value; 11) Pregnant or lactating women (the spouses of fertile women or male patients and their partners are unwilling or unable to agree to use effective contraception during the whole study period and within 3 months after the end of treatment, and the definition of effective contraception will be determined according to the judgment of the researcher); 12) Those who have participated in other clinical trials that may affect the trial within one month; 13) The researcher believes that the subject has the following conditions: may pose a safety risk to the subject in this test, may interfere with the evaluation of safety and effectiveness, or other conditions that are not suitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Event-Free Survival;Overall Survival;Pain relief rate;Device operation performance; | — |
Countries
China
Contacts
Public ContactRufuChen
Guangdong Provincial People's Hospital
Outcome results
None listed