The aim of this study was to compare the therapeutic efficacy between simultaneous gemcitabine administration and IRE and IRE alone for locally advanced pancreatic cancer (LAPC)
in the GEM- IRE group, before the IRE ablation started, patients received 1000 mg/m2 gemcitabine hydrochloride \[Qilu pharmaceutical (Hainan) Co., Ltd. Haikou, China\] intravenously (over approximately 30 min). In the IRE group, the IRE ablation was performed without gemcitabine intravenous infusion before IRE. The aim of this study was to evslusted the overall survival (OS), objective response rate (ORR) and adverse events after simultaneous therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
61
gemcitabine intravenous infusion prior to irreversible electroporation treatment
percutaneous irreversible electroporation was performmed for locally advaanced pancreatic cancer.
FUDA Cancer Hospital
Guangzhou, Guangdong, China
Safety (number of adverse effects)
Adverse events
Time frame: 3 month
Tumor response
Imaging evaluation
Time frame: 12 months
Overall survival (OS)
Overall survival (OS) was defined using time of death.
Time frame: 36 months
Carbohydrate antigen 19-9 (CA19-9)
carbohydrate antigen 19-9 (CA19-9) levels were measured.
Time frame: 1 month
Technical success of ablation
The technical success addressed whether the tumor was treated according to protocol and was covered completely by the ablation zone.
Time frame: 3 months
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