Clinical trial NCT02981719: Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer
Official title: Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety (number of adverse effects)
timeFrame: 3 month
Secondary outcomes:
measure: Tumor response
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 36 months
measure: Carbohydrate antigen 19-9 (CA19-9)
timeFrame: 1 month
measure: Technical success of ablation
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: FUDA Cancer Hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PHD
role: STUDY_CHAIR
References: