γδ T Cell Immunotherapy for Treatment of Liver Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Relief degree of tumors
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients with other kinds of cancer
- •History of coagulation disorders or anemia
- •Patients with heart disease
Outcomes
Primary Outcomes
Relief degree of tumors
Time Frame: 3 months
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Overall survival（OS）
Time Frame: 3 years
Progress free survival（PFS）
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported