The purpose of this study is to evaluate the efficacy and safety of ET 140202 -T cell combined With TAE or Sorafenib in the treatment of liver cancer
The molecular target for ET140202-T cells is HLA-A02 complexed with a HLA-A02-restricted peptide of alpha fetoprotein (AFP), which is expressed on 60-80 percent of hepatocellular carcinoma (HCC). This clinical study evaluates the safety and pharmacokinetics of ET140202-T cells with TAE or Sorafenib in patients with HCC who have no available curative therapeutic options and a poor overall prognosis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
1. Sorafenib starting dose of 400mg b.i.d. a.c. 2. Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct by intravenous (IV) infusion
1. Transarterial embolization(TAE) treatment 2. Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct -intravenous (i.v.)
Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) - expression construct -intravenous (i.v.)
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGFrequency of ARTEMIS T cell treatment-related adverse events
Include but not limited to: Fever, chills, nausea, vomiting, jaundice and other gastrointestinal symptoms; Fatigue, hypotension, respiratory distress; Tumor lysis syndrome; Cytokine release syndrome; Neutropenia, thrombocytopenia; Liver and kidney dysfunction. Assessed at all visits.
Time frame: 28 days up to 2 years
Rate of disease response by RECIST in the liver
Response rates will be estimated as the percent of patients with objective response (OR),which was defined as any of complete remission (CR), partial response (PR) at 2 years.
Time frame: 2 years
Rate of disease response by RECIST at non-liver sites
Response rates will be estimated as the percent of patients with objective response (OR), complete remission (CR), partial response (PR), stable disease (SD), no response (NR), overall survival (OS).
Time frame: 2 years
Progression free survival (PFS)
Progression free survival (PFS) at 4 months, 1 year and 2 years
Time frame: at 4 months, 1 year, 2 years
Median Survival(MS)
Median Survival(MS)at 4 months, 1 year and 2 years
Time frame: at 4 months, 1 year, 2 years
Overall survival(OS)
overall survival(OS)at 2 years
Time frame: at 2 years
AFP serum levels
Percent change compared to the baseline
Time frame: 2 years
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Number of ET140202-T cells in peripheral blood
Number of ET140202-T cells in peripheral blood will be presented as Time to peak, Time to baseline level
Time frame: 2 years
Alpha-fetoprotein (AFP) expression in tumors
Percent of AFP-positive cells in randomly selected fields in tumor biopsies.
Time frame: 4-8 weeks
IL-6 serum levels
Amount change compared to the baseline
Time frame: 4-8 weeks
IL-2 serum levels
Amount change compared to the baseline
Time frame: 4-8 weeks
IL-10 serum levels
Amount change compared to the baseline
Time frame: 4-8 weeks
TNF-α serum levels
Amount change compared to the baseline
Time frame: 4-8 weeks
IFN-γ serum levels
Amount change compared to the baseline
Time frame: 4-8 weeks