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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

September 1, 2019

Primary Completion Date

June 30, 2021

Study Completion Date

July 30, 2021

Conditions
Locally Advanced Pancreatic Adenocarcinoma
Interventions
DEVICE

Irreversible electroporation

During the IRE process, we employed a CT scanner and an ultrasound system to guide percutaneous insertion of the electrode probes (one main electrode and one to three standard electrodes were used per treatment). The electrode number, electrode-insertion mode and intraoperative parameters were decided upon during pretreatment planning. The IRE parameters were visually simulated in the pulse generator and set up as follows: energy was applied at 1500 V/cm for 90 ms/pulse for a total of 7-9 pulses. After an initial testing pulse train was discharged to establish the best voltage value, the remaining 80 pulses were completed in 1-2 minutes. After ablation, we confirmed completion of IRE by measuring real-time resistance or current changes, in addition to intraoperative ultrasound and CT.

DRUG

Gemcitabine

Gemcitabine hydrochloride (Qilu pharmaceutical \[Hainan\] Co., Ltd. Haikou, China\] was administered by intravenous infusion at a dose of 1000 mg/m2.

Trial Locations (1)

510665

Institutional Review Board of Guangzhou FUDA Cancer Hospital, Guangzhou

All Listed Sponsors
lead

Fuda Cancer Hospital, Guangzhou

OTHER

NCT03673137 - Phase II/III of Randomized Controlled Clinical Research on IRE Synchronous Chemotherapy for LAPC | Biotech Hunter | Biotech Hunter