Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Biological: NK cells; Procedure: irreversible electroporation (IRE )

• Registration Number: NCT02718859
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

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

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-19
• Study First Posted: 2016-03-24
• Primary Completion: 2017-03-01
• Status Verified: 2019-03
• Study Completion: 2019-03-01
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IRE & NK cells	NK cells	Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells
irreversible electroporation (IRE)	irreversible electroporation (IRE )	Advanced pancreatic cancer patients received only irreversible electroporation (IRE) without immunotherapy
IRE & NK cells	irreversible electroporation (IRE )	Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells

Primary Outcome Measures

Name	Time	Method
Relief degree	1 year	It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

Secondary Outcome Measures

Name	Time	Method
Overall survival（OS）	3 year
Progress free survival（PFS）	1 year

Trial Locations

Locations (1)

Central laboratory in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China