Safety and Efficiency of γδ T Cell Against Liver Cancer

NCT03183219 | Completed Phase 1 DMC

• 1 other identifier: Gd T cell and liver Ca
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Cancer

Keywords

Immunotherapy, γδ T Cell, Liver Cancer

Outcome Measures

Primary Outcomes (3)

• Relief degree of tumors

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

  3 months

• Progress free survival（PFS）

  1 year

• Overall survival（OS）

  3 years

Study Arms (3)

Group A

EXPERIMENTAL

In this group, the patients will receive under CT Cryosurgery or IRE surgery to control the local tumor.

Procedure: Cryosurgery or IRE surgery

Group B

EXPERIMENTAL

In this group, the patients will receive multiple high-activity γδ T cell immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Biological: γδ T cell

Group C

EXPERIMENTAL

In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery or IRE surgery

Other: γδ T cells/ A Cryosurgery or IRE

Interventions

Cryosurgery or IRE surgery PROCEDURE

Cryosurgery or IRE surgery will be used in local tumor

Group A

γδ T cell BIOLOGICAL

γδ T cells will be used against Liver Cancer

Group B

γδ T cells/ A Cryosurgery or IRE OTHER

Combination γδ T cell and Cryosurgery or IRE surgery will be used in Liver Cancer

Group C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75
• Karnofsky performance status \>50
• Diagnosis with Liver Cancer based on histology or the current accepted radiological measures
• Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
• Will receive cryosurgery, IRE, gd T cells
• Life expectancy: Greater than 3 months
• Ability to understand the study protocol and a willingness to sign a written informed consent document

You may not qualify if:

• Patients with other kinds of cancer
• History of coagulation disorders or anemia
• Patients with heart disease

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• Jinan University Guangzhou: collaborator

Study Sites (1)

Biotherapy center in Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Cryosurgery; Electroporation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Jibing Chen, PhD

  Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 12, 2017
• Study Start: June 15, 2017
• Primary Completion: January 15, 2018
• Study Completion: June 15, 2019
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

CN (1)