Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer

Fuda Cancer Hospital, Guangzhou

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pancreatic Cancer

Treatments: Procedure: irreversible electroporation (IRE ); Biological: NK cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02718859

NK-pancre

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

irreversible electroporation (IRE)

Active Comparator group

Description:

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

Treatment:

Procedure: irreversible electroporation (IRE )

IRE & NK cells

Experimental group

Description:

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

Treatment:

Procedure: irreversible electroporation (IRE )

Biological: NK cells