This is a single-center, single-arm, prospective clinical trial to investigate the safety and efficacy of Neo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs.
The study screened patients with PD-1 immunochemotherapy in the first-line treatment regimen, and extracted tumor tissues from patients after PD-1 resistance for neoantigen prediction. During neoantigen screening and vaccine preparation, patients received a second-line regimen (docetaxel) as bridging therapy. After completion of bridging therapy and the patient 's vaccine preparation was successful, the patient started receiving the vaccine combined with ICIs. The completion of 5 vaccine injections was followed by an immunization course. Efficacy was assessed 2 weeks after the end of an immunization course, and if effective (tumor response evaluated as SD/PR/CR), the next cycle of immunotherapy was continued, with subsequent treatments administered every 3 weeks until disease progression or severe intolerance occurred or the patient requested withdrawal, whichever came first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Neo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs.
West China Hospital
Chengdu, Sichuan, China
RECRUITINGThe safety of Neo-DCVac combined with ICIs.
This study will collected any adverse medical events that occurred during the study drug treatment, and the treatment-related adverse events as assessed by" CTCAE v5.0".
Time frame: 2 years
The efficacy of Neo-DCVac combined with ICIs.
Using the revisit1.1 tumor evaluation criteria for efficacy evaluation, evaluate disease progression free survival (PFS) .
Time frame: 2 years
The efficacy of Neo-DCVac combined with ICIs.
Using the revisit1.1 tumor evaluation criteria for efficacy evaluation, evaluate disease objective response rate (ORR).
Time frame: 2 years
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