Safety and Efficiency of γδ T Cell Against Liver Cancer

Liver Cancer Clinical Trial

Official title:

γδ T Cell Immunotherapy for Treatment of Liver Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183219
• Other study ID #: Gd T cell and liver 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 Liver Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 15, 2019
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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: ?,?,?

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

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

Biological:
• ?d T cell
?d T cells will be used against Liver Cancer

Other:
• ?d T cells/ A Cryosurgery or IRE
Combination ?d T cell and Cryosurgery or IRE surgery will be used in Liver 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	Relief degree of tumors	It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)	3 months
Primary	Progress free survival(PFS)		1 year
Primary	Overall survival(OS)		3 years