eligibility_summary
Inclusion: Adults ≥18 with resectable cutaneous head/neck angiosarcoma, consent and biopsy for vaccine, ECOG ≤2, adequate labs: Hb ≥8 g/dL, ANC ≥1500, lymphs ≥500, platelets ≥75k, CD4 ≥200, GFR >60, bilirubin ≤1.5×ULN, AST/ALT ≤2.5×ULN, TSH 0.4–4.0, aPTT/INR ≤1.5×ULN or therapeutic on anticoagulants. Exclusion: unresectable/metastatic, live vaccine ≤30 d, uncontrolled HIV or active HBV/HCV needing antivirals, steroids/immunosuppressants, autoimmune disease, pregnant/breastfeeding/no contraception, other trials, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I (withdrawn) adjuvant immunotherapy for resectable cutaneous head & neck angiosarcoma with dose-escalation of an autologous TH1 dendritic cell (DC) vaccine loaded with patient tumor lysate plus mRNA. Interventions and mechanisms: • mRNA + lysate-loaded DC vaccine (biologic): DCs process lysate and translated mRNA-encoded antigens, present via MHC I/II, and drive TH1 polarization to activate CD8+ cytotoxic T cells and CD4+ TH1 cells, boosts IFN-γ–mediated anti-tumor immunity. Targets/pathways: dendritic cells, antigen presentation, T-cell priming/TH1 response. • Paclitaxel (chemotherapy): microtubule stabilizer causing mitotic arrest and immunogenic tumor cell death, targets tubulin/microtubules. • Peginterferon alfa-2a (cytokine): IFNAR–JAK/STAT signaling to enhance MHC expression, antiproliferative and immune-stimulating effects. • Filgrastim/G-CSF (growth factor): CSF3R agonist expanding neutrophils/mobilizing precursors.