search
Back to results

Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
NK cells
irreversible electroporation (IRE )
Sponsored by
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring advanced pancreatic cancer, nature killer cell, irreversible electroporation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age:18-80
  2. Diagnosis：advanced and active pancreatic cancer
  3. The tumour is measurable
  4. Eastern Cooperative Oncology Group(ECOG) score：0~2；3 but has no relationship with tumour

  5. Vital organ function is normal:

    total bilirubin(TB) <68μmol/L aspartate aminotransferase(AST)<90 IU/L Cre<353μmol/L white blood cell count(WBC)<9×10^9/L,when WBC is close to or even greater than 9×10^9/L，the recommended dose should be halved platelet count(PLT)>80×10^9/L Red blood cell specific volume(HCT)>0.20 Non severe viral or bacterial infection

  6. Non pregnant and lactating patients
  7. Non allergic reactions to biological products
  8. Informed and consent

Exclusion Criteria:

  1. Patients with cardiac pacemaker
  2. Patients with severe cardiac and pulmonary dysfunction
  3. Patients that the researchers do not think fit into the group,including patients failed in compliance assessment

Sites / Locations

  • Central laboratory in Fuda cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

irreversible electroporation (IRE)

IRE & NK cells

Arm Description

Advanced pancreatic cancer patients received only irreversible electroporation (IRE) without immunotherapy

Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells

Outcomes

Primary Outcome Measures

Relief degree
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

Secondary Outcome Measures

Progress free survival（PFS）
Overall survival（OS）

Full Information

First Posted
March 9, 2016
Last Updated
September 10, 2019
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Shenzhen Hank Bioengineering Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02718859
Brief Title
Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer
Official Title
Study of the Combined Therapy of Irreversible Electroporation（IRE） and Nature Killer (NK) Cells for Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Shenzhen Hank Bioengineering Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the combined therapy using irreversible electroporation（IRE）and nature killer(NK) cells for advanced pancreatic cancer.
Detailed Description
By enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using irreversible electroporation（IRE）and nature killer（NK） cells for advanced pancreatic cancer. The efficacy will be evaluated according to relief degree,progress free survival(PFS) and overall survival(OS). The safety will be evaluated by statistics of adverse reaction

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
advanced pancreatic cancer, nature killer cell, irreversible electroporation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
irreversible electroporation (IRE)
Arm Type
Active Comparator
Arm Description
Advanced pancreatic cancer patients received only irreversible electroporation (IRE) without immunotherapy
Arm Title
IRE & NK cells
Arm Type
Experimental
Arm Description
Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells
Intervention Type
Biological
Intervention Name(s)
NK cells
Intervention Description
The pancreatic cancer patients will receive nature killer(NK) cells infusions,qd
Intervention Type
Procedure
Intervention Name(s)
irreversible electroporation (IRE )
Intervention Description
The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE )
Primary Outcome Measure Information:
Title
Relief degree
Description
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progress free survival（PFS）
Time Frame
1 year
Title
Overall survival（OS）
Time Frame
3 year

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: Age:18-80 Diagnosis：advanced and active pancreatic cancer The tumour is measurable Eastern Cooperative Oncology Group(ECOG) score：0~2；3 but has no relationship with tumour Vital organ function is normal: total bilirubin(TB) <68μmol/L aspartate aminotransferase(AST)<90 IU/L Cre<353μmol/L white blood cell count(WBC)<9×10^9/L,when WBC is close to or even greater than 9×10^9/L，the recommended dose should be halved platelet count(PLT)>80×10^9/L Red blood cell specific volume(HCT)>0.20 Non severe viral or bacterial infection Non pregnant and lactating patients Non allergic reactions to biological products Informed and consent Exclusion Criteria: Patients with cardiac pacemaker Patients with severe cardiac and pulmonary dysfunction Patients that the researchers do not think fit into the group,including patients failed in compliance assessment
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
Central laboratory in Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Learn more about this trial

Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer

We'll reach out to this number within 24 hrs