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Completed

NCT Number: NCT03183219

Safety and Efficiency of γδ T Cell Against Liver Cancer

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Biotherapy center in Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-75
  • 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

Treatment and study plan

Cryosurgery or IRE surgery

Procedure

Cryosurgery or IRE surgery will be used in local tumor

γδ T cell

Biological

γδ T cells will be used against Liver Cancer

γδ T cells/ A Cryosurgery or IRE

Other

Combination γδ T cell and Cryosurgery or IRE surgery will be used in Liver Cancer

Primary outcomes

  1. Relief degree of tumors

    Time frame: 3 months

    It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)

  2. Progress free survival(PFS)

    Time frame: 1 year

  3. Overall survival(OS)

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Collaborators

  • Jinan University Guangzhou

Registry information

Official study title

γδ T Cell Immunotherapy for Treatment of Liver Cancer

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 12, 2017
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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