eligibility_summary
Adults 18–80 (≥40 kg) with histologically/cytologically confirmed malignant solid tumors post-radical resection, no residual lesions/metastases (incl. brain), ECOG 0–1, adequate venous access, organ function (LVEF ≥50%, acceptable marrow/renal/hepatic/coagulation labs, SaO2 ≥91%), able to consent, safety stage requires Survivin or P53 IHC+. Exclude: HIV/syphilis, active HBV viremia/HCV, uncontrolled infection/major disease, pregnancy/lactation, active autoimmune/CNS disease, immunosuppression/steroids, severe allergy, significant CV disease, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Baize DC Injection/Super DC Vaccine—an autologous dendritic cell (DC) vaccine (1×10^7 cells) given post–radical surgery in solid tumors to prevent recurrence/metastasis. Mechanism: ex vivo–prepared DCs serve as professional antigen-presenting cells to prime tumor-specific T-cell immunity, enhancing CD8+ cytotoxic and CD4+ helper responses and immune surveillance against residual micrometastatic disease. Cells/pathways targeted: dendritic cells and downstream T-cell activation via MHC antigen presentation, costimulation (CD80/CD86), and Th1/CTL cytokines (e.g., IFN-γ). Safety stage requires tumor Survivin or p53 positivity, suggesting focus on these tumor-associated antigens. Design: single-arm Phase 1 in China.