Spots Global Cancer Trial Database for Immunotherapy of Advanced Hepatitis B Related Hepatocellular Carcinoma With γδT Cells
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Trial Identification
Brief Title: Immunotherapy of Advanced Hepatitis B Related Hepatocellular Carcinoma With γδT Cells
Official Title: Immunotherapy of Advanced Hepatitis B Related Hepatocellular Carcinoma With γδT Cells
Study ID: NCT04032392
Conditions
Interventions
Study Description
Brief Summary: To evaluate the safety, tolerability and efficacy of autologous γδT cells in the treatment of advanced hepatitis B-related hepatocellular carcinoma.
Detailed Description: This is a single-centre, non-randomised, open label, no control, prospective clinical trial. The study will include the following sequential phases: sign informed consent, γδT cells pre-culture, fresh biopsy and screening, apheresis, γδT cells preparation, treatment and follow-up. The study will evaluate the safety, tolerability and efficacy of autologous γδT cells in patients with advanced hepatitis B related hepatocellular carcinoma (HCC) which are refractory to current treatment. Stage I comprising a safety cohort of patients to identify a safe dose, Stage II comprising an expanded patient group for response signal identification, Stage III to confirm efficacy and safety.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing 302 Hospital of China, Beijing, Beijing, China
Beijing 302 hospital, Beijing, , China
Contact Details
Name: Fu-Sheng Wang, Dr
Affiliation: Beijing 302 Hospital
Role: PRINCIPAL_INVESTIGATOR
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