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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03180437
• Other study ID #: Gd T cell and Pancreatic Ca
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 15, 2017
• Est. completion date: June 15, 2019

Study information

• Verified date: July 2020
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 15, 2019
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• IRE surgery
IRE surgery will be used in local tumor

Biological:
• IRE plus ?d T cells
Combination IRE surgery and ?d T cell will be used in Pancreatic Cancer

Locations

Country	Name	City	State
China	Biotherapy center in Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou	Jinan University Guangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	PFS was defined as the interval between treatment initiation and local relapse	2 years
Primary	OS	OS was calculated as the interval from treatment initiation to death.	2 year
Secondary	Tumor size	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
Secondary	CTC	The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.	3 months
Secondary	CA 19-9	The serum concentrations of CA19-9 were evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment.	3 months