Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer

NCT02718859 | Completed Phase 1 DMC

• 1 other identifier: NK-pancre
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

advanced pancreatic cancer; nature killer cell; irreversible electroporation

Outcome Measures

Primary Outcomes (1)

• Relief degree

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

  1 year

Secondary Outcomes (2)

• Progress free survival（PFS）

  1 year

• Overall survival（OS）

  3 year

Study Arms (2)

irreversible electroporation (IRE)

ACTIVE COMPARATOR

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

Procedure: irreversible electroporation (IRE )

IRE & NK cells

EXPERIMENTAL

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

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

Interventions

NK cells BIOLOGICAL

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

IRE & NK cells

irreversible electroporation (IRE ) PROCEDURE

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

IRE & NK cells; irreversible electroporation (IRE)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• Shenzhen Hank Bioengineering Institute: collaborator

Study Sites (1)

Central laboratory in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Lizhi Niu, PhD

  Fuda Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 24, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-03

Locations

CN (1)