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| Name | Class |
|---|---|
| Jinan University Guangzhou | OTHER |
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In this study, effects of γδT cells on human Liver Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | In this group, the patients will receive under CT Cryosurgery or IRE surgery to control the local tumor. |
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| 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). |
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| Group C | Experimental | In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery or IRE surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryosurgery or IRE surgery | Procedure | Cryosurgery or IRE surgery will be used in local tumor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jibing Chen, PhD | Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotherapy center in Fuda cancer hospital | Guangzhou | Guangdong | 510665 | China |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D018274 | Electroporation |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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| γδ T cell |
| Biological |
γδ T cells will be used against Liver Cancer |
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| γδ T cells/ A Cryosurgery or IRE | Other | Combination γδ T cell and Cryosurgery or IRE surgery will be used in Liver Cancer |
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| D008107 |
| Liver Diseases |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |