Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer

NCT02981719 | Completed DMC

• 1 other identifier: Y2016-MS-001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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)

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Safety (number of adverse effects)

  Adverse events

  3 month

Secondary Outcomes (4)

• Tumor response

  12 months

• Overall survival (OS)

  36 months

• Carbohydrate antigen 19-9 (CA19-9)

  1 month

• Technical success of ablation

  3 months

Study Arms (2)

simultaneous gemcitabine and irreversible electroporation

EXPERIMENTAL

gemcitabine intravenous infusion prior to irreversible electroporation treatment.

Procedure: simultaneous gemcitabine and irreversible electroporation

IRE group

OTHER

percutaneous irreversible electroporation for locally advanced pancreatic cancer.

Procedure: irreversible electroporation

Interventions

simultaneous gemcitabine and irreversible electroporation PROCEDURE

gemcitabine intravenous infusion prior to irreversible electroporation treatment

simultaneous gemcitabine and irreversible electroporation

irreversible electroporation PROCEDURE

percutaneous irreversible electroporation was performmed for locally advaanced pancreatic cancer.

IRE group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiologic confirmation of unresectable locally advanced pancreatic cancer by at least CT of chest and abdomen
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead

Study Sites (1)

FUDA Cancer Hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Lizhi Niu, PHD

  Fuda Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: December 5, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

CN (1)