Safety and Efficiency of γδ T Cell Against Liver Cancer

Phase 1

Completed

• Conditions: Liver Cancer
• Interventions: Biological: γδ T cell; Procedure: Cryosurgery or IRE surgery; Other: γδ T cells/ A Cryosurgery or IRE

• Registration Number: NCT03183219
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

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.

Detailed Description

A liver tumor will be removed using tumor reducing surgery such as cryosurgery.PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-CIK, they will be infused to the patients as an immunotherapy treatment.

NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of cancer patients could not be effectively expanded, including cell number, cell purity and cell function could not meet the requirements of reinfusion. Meanwhile, those patients could not tolerate 100ml of blood drawing for culture every 2 \~ 3 weeks.

Therefore, we submitted new clinical study application to the ethical committee of the Fuda Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted allogeneic cells instead of autologous in our subsequentially clinical study.

Study Timeline

• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-12
• Study Start: 2017-06-15
• Primary Completion: 2018-01-15
• Study Completion: 2019-06-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-10
• Last Update Posted: 2020-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

1. Patients with other kinds of cancer
2. History of coagulation disorders or anemia
3. Patients with heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Relief degree of tumors	3 months	It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Overall survival（OS）	3 years
Progress free survival（PFS）	1 year

Trial Locations

Locations (1)

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