Pancreatic Cancer
Conditions
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.
Interventions
PROCEDUREsimultaneous gemcitabine and irreversible electroporation
gemcitabine intravenous infusion prior to irreversible electroporation treatment
PROCEDUREirreversible electroporation
percutaneous irreversible electroporation was performmed for locally advaanced pancreatic cancer.
Sponsors
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (number of adverse effects) | 3 month | Adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | 12 months | Imaging evaluation |
| Overall survival (OS) | 36 months | Overall survival (OS) was defined using time of death. |
| Carbohydrate antigen 19-9 (CA19-9) | 1 month | carbohydrate antigen 19-9 (CA19-9) levels were measured. |
| Technical success of ablation | 3 months | The technical success addressed whether the tumor was treated according to protocol and was covered completely by the ablation zone. |
Countries
China
Outcome results
None listed