Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer

October 29, 2020 updated by: Fuda Cancer Hospital, Guangzhou
In this study, effects of γδT cells on human Pancreatic Cancer in combination with tumor reducing surgery, for example IRE going to be investigated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pancreatic tumor will be removed using tumor reducing surgery such as IRE. PBMC of the healthy donor will be separated from peripheral blood. After making them potential cancer killer γδ T Cell, they will be infused to the patients as an immunotherapy treatment.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510665
        • Biotherapy center in Fuda cancer hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age: >18 years
  2. participants older than 18 years with either LAPC according to the American Joint Committee on Cancer (AJCC) criteria or isolated local recurrence with a maximum tumor diameter of 5 cm were considered eligible after pathologic confirmation
  3. will receive IRE, gd Tcells
  4. life expectancy: more than 3 months
  5. ability to understand the study protocol and a willingness to sign a written informed consent document
  6. adequate liver and renal function were required
  7. intolerant or refused to chemotherapy or to chemotherapy

Exclusion Criteria:

  1. patients with other kinds of cancer
  2. history of coagulation disorders or anemia
  3. heart disease and diabetes
  4. history of epilepsy, severe coronary disease, a history of level 3 hypertension，myelosuppression, autoimmune disease
  5. a performance status score of >2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
In this group, the patients will receive IRE surgery to control the local tumor under CT .
Procedure: IRE surgery
IRE surgery will be used in local tumor
Experimental: Group B
In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and IRE surgery
Biological: IRE plus γδ T cells
Combination IRE surgery and γδ T cell will be used in Pancreatic Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 2 years
PFS was defined as the interval between treatment initiation and local relapse
2 years
OS
Time Frame: 2 year
OS was calculated as the interval from treatment initiation to death.
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor size
Time Frame: 3 months
The tumor responses of the enrolled patients were assessed by CT in accordance with RECIST v1.1.Institute Common Terminology Criteria for Adverse Events (v4.0).
3 months
CTC
Time Frame: 3 months
The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.
3 months
CA 19-9
Time Frame: 3 months
The serum concentrations of CA19-9 were evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

Jinan University Guangzhou

Investigators

  • Principal Investigator: Jibing Chen, PhD, Biological treatment center in Fuda cancer hospital Guangzhou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2017

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

June 15, 2019

Study Registration Dates

First Submitted

May 19, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gd T cell and Pancreatic Ca

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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