Skip to main content
OpenTrials
Completed

NCT Number: NCT03180437

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

In this study, effects of γδT cells on human Pancreatic Cancer in combination with tumor reducing surgery, for example IRE going to be investigated.

Completed

Looking for future studies?

Notify Me

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

Biotherapy center in Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age: >18 years
  • 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
  • will receive IRE, gd Tcells
  • life expectancy: more than 3 months
  • ability to understand the study protocol and a willingness to sign a written informed consent document
  • adequate liver and renal function were required
  • intolerant or refused to chemotherapy or to chemotherapy

Exclusion criteria

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

Treatment and study plan

IRE surgery

Procedure

IRE surgery will be used in local tumor

IRE plus γδ T cells

Biological

Combination IRE surgery and γδ T cell will be used in Pancreatic Cancer

Primary outcomes

  1. PFS

    Time frame: 2 years

    PFS was defined as the interval between treatment initiation and local relapse

  2. OS

    Time frame: 2 year

    OS was calculated as the interval from treatment initiation to death.

Secondary outcomes

  1. 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).

  2. CTC

    Time frame: 3 months

    The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.

  3. 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.

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Collaborators

  • Jinan University Guangzhou

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 8, 2017
Registry last updated
Nov 2, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.