Back to resultsSimultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
simultaneous gemcitabine and irreversible electroporation
irreversible electroporation
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
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
Sites / Locations
- FUDA Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
simultaneous gemcitabine and irreversible electroporation
IRE group
Arm Description
gemcitabine intravenous infusion prior to irreversible electroporation treatment.
percutaneous irreversible electroporation for locally advanced pancreatic cancer.
Outcomes
Primary Outcome Measures
Safety (number of adverse effects)
Adverse events
Secondary Outcome Measures
Tumor response
Imaging evaluation
Overall survival (OS)
Overall survival (OS) was defined using time of death.
Carbohydrate antigen 19-9 (CA19-9)
carbohydrate antigen 19-9 (CA19-9) levels were measured.
Technical success of ablation
The technical success addressed whether the tumor was treated according to protocol and was covered completely by the ablation zone.
Full Information
NCT ID
NCT02981719
First Posted
October 31, 2016
Last Updated
January 17, 2021
Sponsor
Fuda Cancer Hospital, Guangzhou
1. Study Identification
Unique Protocol Identification Number
NCT02981719
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
simultaneous gemcitabine and irreversible electroporation
Arm Type
Experimental
Arm Description
gemcitabine intravenous infusion prior to irreversible electroporation treatment.
Arm Title
IRE group
Arm Type
Other
Arm Description
percutaneous irreversible electroporation for locally advanced pancreatic cancer.
Intervention Type
Procedure
Intervention Name(s)
simultaneous gemcitabine and irreversible electroporation
Intervention Description
gemcitabine intravenous infusion prior to irreversible electroporation treatment
Intervention Type
Procedure
Intervention Name(s)
irreversible electroporation
Intervention Description
percutaneous irreversible electroporation was performmed for locally advaanced pancreatic cancer.
Primary Outcome Measure Information:
Title
Safety (number of adverse effects)
Description
Adverse events
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Tumor response
Description
Imaging evaluation
Time Frame
12 months
Title
Overall survival (OS)
Description
Overall survival (OS) was defined using time of death.
Time Frame
36 months
Title
Carbohydrate antigen 19-9 (CA19-9)
Description
carbohydrate antigen 19-9 (CA19-9) levels were measured.
Time Frame
1 month
Title
Technical success of ablation
Description
The technical success addressed whether the tumor was treated according to protocol and was covered completely by the ablation zone.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lizhi Niu, PHD
Organizational Affiliation
Fuda Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
FUDA Cancer Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer
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