Safety and Efficiency of γδ T Cell Against Liver Cancer

Fuda Cancer Hospital, Guangzhou

Status and phase: Completed; Phase 2; Phase 1

Conditions: Liver Cancer

Treatments: Biological: γδ T cell; Procedure: Cryosurgery or IRE surgery; Other: γδ T cells/ A Cryosurgery or IRE

Study type: Interventional

Funder types: Other

Identifiers

NCT03183219

Gd T cell and liver Ca

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Group A

Experimental group

Description:

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

Treatment:

Procedure: Cryosurgery or IRE surgery

Group B

Experimental group

Description:

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).

Treatment:

Biological: γδ T cell

Group C

Experimental group

Description:

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

Treatment:

Other: γδ T cells/ A Cryosurgery or IRE