To confirm the result of previous Phase I/II and phase II clinical trials, this trial is to test the efficacy and safety of ADCTA immunotherapy plus the standard therapy in comparison with standard therapy alone in patients with recurrent GBM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
ADCTA is an individualized cell immunotherapy co-culturing autologous dendritic cells derived from peripheral blood mononuclear cells (PBMNCs) with autologous tumor cell as antigen in order to evoke specific immune response.
Chang Gung Memorial Hospital, Chiayi branch
Chiayi City, Taiwan
RECRUITINGChang Gung Memorial Hospital, Kaohsiung branch
Kaohsiung City, Taiwan
RECRUITINGChang Gung Memorial Hospital, Keelung branch
Keelung, Taiwan
Overall Survival (OS)
Time frame: The duration will be calculated from the date of randomization until the date of death from any cause, assessed up to 60 months.
Progression-free Survival (PFS)
Time frame: The duration will be calculated from the date of randomization until the date of first documented progression according to the modified RANO or date of death from any cause, whichever came first,assessed up to 60 months.
Progression-free Survival at 6 months (PFS6)
Time frame: The duration will be calculated from the date of randomization to the date of the sixth month.
1 and 2-year Survival Rate
Time frame: The duration will be calculated from the date of randomization to the date of the first year and the second year.
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Taichung Veterans General Hospital
Taichung, Taiwan
RECRUITINGNational Cheng Kung University Hospital
Tainan, Taiwan
RECRUITINGChi Mei Medical Center
Tainan, Taiwan
RECRUITINGChang Gung Memorial Hospital, Linkou branch
Taoyuan City, Taiwan
RECRUITING