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

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Procedure: IRE surgery; Biological: IRE plus γδ T cells

• Registration Number: NCT03180437
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-08
• Study Start: 2017-06-15
• Primary Completion: 2018-06-15
• Study Completion: 2019-06-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	IRE surgery	In this group, the patients will receive IRE surgery to control the local tumor under CT .
Group B	IRE plus γδ T cells	In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and IRE surgery

Primary Outcome Measures

Name	Time	Method
PFS	2 years	PFS was defined as the interval between treatment initiation and local relapse
OS	2 year	OS was calculated as the interval from treatment initiation to death.

Secondary Outcome Measures

Name	Time	Method
Tumor size	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).
CTC	3 months	The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.
CA 19-9	3 months	The serum concentrations of CA19-9 were evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment.

Trial Locations

Locations (1)

Biotherapy center in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China