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NCT Number: NCT02718859

Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Central laboratory in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NK Cells

Biological

The pancreatic cancer patients will receive nature killer(NK) cells infusions,qd

irreversible electroporation (IRE )

Procedure

The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE )

Primary outcomes

  1. Relief degree

    Time frame: 1 year

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

Secondary outcomes

  1. Progress free survival（PFS）

    Time frame: 1 year

  2. Overall survival（OS）

    Time frame: 3 year

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Collaborators

  • Shenzhen Hank Bioengineering Institute

Registry information

Official study title

Study of the Combined Therapy of Irreversible Electroporation（IRE） and Nature Killer (NK) Cells for Advanced Pancreatic Cancer

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Mar 24, 2016
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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