The study is to investigate the safety and efficacy of dendritic cells vaccines pulsed with autologous whole tumor cell lysate for treating advanced solid tumor patients with high tumor mutation burden.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
personalized vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous tumor cells, administered intranodally on day 1,8,15, with a combination of oral cyclophosphamide (50mg) every day except the day of vaccine administrations.Cycles are repeated every 21 days. Treatment is continued until disease progression or exhaustion of vaccine supply, whichever comes first.
Capital Medical University Cancer Center/Beijing Shijitan Hospital
Beijing, Beijing Municipality, China
Treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.All toxicities observed within 30 days of last vaccination will be included.
Time frame: 12 months
Objective response rate (ORR)
The rate of patients was evaluated as complete response or partial response
Time frame: 6 months
Progression-free survival of the participants(PFS)
From starting date of vaccine treatment until date of first documented disease progression or date of death from any cause, whichever comes first
Time frame: 24 months
Overall survival of the participants(OS)
From starting date of vaccine treatment until date of death from any cause
Time frame: 24 months
The changes in immune-response specific patient-reported outcomes(irPRO)
To assess the irPRO scale ratings prior to and after the cancer immunotherapy
Time frame: 24 months
The changes in patient self-reported quality of life
To assess the EORTC QLQ-C30 scale ratings prior to and after the cancer immunotherapy
Time frame: 24 months
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