Overview

Clinical Application of IRE Combined With Chemotherapy in the Treatment of Pancreatic Cancer

Status:
Recruiting
Trial end date:
0000-00-00
Target enrollment:
20
Participant gender:
Both
Summary
The aim of this study was to observe the survival status, recurrence and death time of patients with pancreatic cancer treated by chemotherapy combined with IRE. The survival and overall survival of the patients were evaluated respectively.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fuda Cancer Hospital, Guangzhou
Treatments:
Gemcitabine
Last Updated:
2016-12-08
Criteria
Inclusion Criteria:

- Radiologic confirmation of unresectable 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

- ASA-classification 0 - 3

- 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 ≥ 5.6 mmol/L

- Absolute neutrophil count (ANC) ≥ 1,500/mm3

- Platelet count ≥ 100*109/l

- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)

- 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

- Activated partial thromboplastin time < 1.25 x ULN (therapeutic anticoagulation
therapy is allowed if this treatment can be interrupted as judged by the treating
physician)

- Written informed consent

Exclusion Criteria:

- Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary
hepatobiliary team

- Successful down staging after (radio)chemotherapy from previous
unresectable/borderline tumor to resectable tumor

- History of epilepsy

- History of cardiac disease:

- Congestive heart failure >NYHA class 2

- Active Coronary Artery Disease (defined as myocardial infarction within 6 months
prior to screening)

- Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for
antihypertensive regimen are permitted)

- Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of
screening on a stable antihypertensive regimen

- 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

- Immunotherapy ≤ 6 weeks prior to the procedure

- Chemotherapy ≤ 6 weeks prior to the procedure

- Radiotherapy ≤ 6 weeks prior to the procedure

- Concomitant use of anti-convulsive and anti-arrhythmic drugs (other than beta
blockers used for antihypertensive)

- Allergy to contrast media

- Any implanted stimulation device

- Any implanted metal stent/device within the area of ablation that cannot be removed

- Any condition that is unstable or that could jeopardize the safety of the subject and
their compliance in the study; Of note, patients with contra-indications for MRI will
not be excluded from participation: in this case radiologic follow-up will consist of
CT-scanning according to protocol.