Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer

Fuda Cancer Hospital, Guangzhou

Status

Completed

Conditions

Pancreatic Cancer

Treatments

Procedure: irreversible electroporation

Procedure: simultaneous gemcitabine and irreversible electroporation

Study type

Interventional

Funder types

Other

Identifiers

NCT02981719

Y2016-MS-001

Details and patient eligibility

About

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)

Full description

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.

Enrollment

61 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Radiologic confirmation of unresectable locally advanced pancreatic cancer by at least CT of chest and abdomen
Screening must be performed no longer than 2 weeks prior to study inclusion
Maximum tumor diameter ≤ 5 cm
Histological or cytological confirmation of pancreatic adenocarcinoma;
Age ≥ 18 years
PS-classification 0 - 2
Life expectancy of at least 12 weeks
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion;
Hemoglobin level ≥ 115 g/L
Platelet count ≥ 100*109/l
Neutrophil count ≥ 2×109/L;
White blood cell count ≥ 4 ×109/L;
ALT and AST ≤ 2.5 x ULN
Serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance ≥ 50 ml/min
Prothrombin time or INR < 1.5 x ULN
Written informed consent

Exclusion criteria

Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team
History of epilepsy
History of cardiac disease:
Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted)
Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites)
Uncontrolled infections (> grade 2 NCI-CTC version 3.0)
Pregnant. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment
Allergy to contrast media
Any implanted stimulation device
Any implanted metal stent/device within the area of ablation that cannot be removed