eligibility_summary
Adults (≥18) with advanced/recurrent cancer after standard therapy failure, ≥1 measurable lesion, ECOG 0–2, life expectancy ≥3 months, sufficient tumor DNA/omics for neoantigen screening or GMP peptides, compliant, women need negative pregnancy test and contraception. Exclude: no neoantigens, prior BMT/SCT, other active trials, active infections (e.g., HIV/HBV/HCV/herpes/respiratory), asthma/autoimmune/immunodeficiency, on immunosuppressants, major CV/CNS disease, relevant allergies, impaired consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II randomized (crossover) study in refractory solid tumors. Interventions: 1) Personalized tumor neoantigen peptide vaccine (biologic, therapeutic cancer peptide vaccine) designed from each patient’s WES/RNA-seq and HLA typing to generate high-affinity HLA-binding mutated peptides, 2) Precision radiotherapy used in both arms (control: placebo + conventional care incl. radiotherapy, experimental: vaccine + radiotherapy). Mechanisms: The vaccine supplies patient-specific mutant peptides for HLA presentation by APCs, priming/expanding neoantigen-specific CD8+ cytotoxic and CD4+ helper T cells to recognize and kill tumor cells bearing those mutations. Radiotherapy serves as an immune-stimulating primer, increasing antigen release and presentation to augment vaccine-induced T-cell responses. Targets/pathways: dendritic cell antigen presentation (HLA class I/II), activation of tumor-specific T-cell immunity, and tumor cells expressing the selected neoantigens.