Pancreatic Cancer
Conditions
Keywords
advanced pancreatic cancer, nature killer cell, irreversible electroporation
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
Interventions
BIOLOGICALNK cells
The pancreatic cancer patients will receive nature killer(NK) cells infusions,qd
PROCEDUREirreversible electroporation (IRE )
The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE )
Sponsors
Shenzhen Hank Bioengineering Institute
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relief degree | 1 year | It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST） |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival（PFS） | 1 year |
| Overall survival（OS） | 3 year |
Countries
China
Outcome results
None listed