Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981719
• Other study ID #: Y2016-MS-001
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: October 1, 2020

Study information

• Verified date: January 2021
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• simultaneous gemcitabine and irreversible electroporation
gemcitabine intravenous infusion prior to irreversible electroporation treatment
• irreversible electroporation
percutaneous irreversible electroporation was performmed for locally advaanced pancreatic cancer.

Locations

Country	Name	City	State
China	FUDA Cancer Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (number of adverse effects)	Adverse events	3 month
Secondary	Tumor response	Imaging evaluation	12 months
Secondary	Overall survival (OS)	Overall survival (OS) was defined using time of death.	36 months
Secondary	Carbohydrate antigen 19-9 (CA19-9)	carbohydrate antigen 19-9 (CA19-9) levels were measured.	1 month
Secondary	Technical success of ablation	The technical success addressed whether the tumor was treated according to protocol and was covered completely by the ablation zone.	3 months