eligibility_summary
Inclusion: ≥75 yrs, advanced/metastatic solid tumor refractory/intolerant/no standard therapy, ECOG 0–3, life expectancy >3 mo, AST/ALT ≤3×ULN (≤5× with liver mets), creatinine ≤1.5×ULN, consent. Exclusion: pregnancy/lactation, other malignancy ≤5 yrs (except cured), uncontrolled CNS/psychiatric disease, major cardiac disease or MI/ACS ≤6 mo, prior allogeneic HSCT/solid organ transplant, serious uncontrolled comorbidities/infections (incl TB), uncontrolled diabetes, drug allergy, immunodeficiency/HIV or chronic steroids, other significant disorders.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm study in elderly patients with advanced solid tumors testing PRaG9.0: hypofractionated radiotherapy plus a PD-L1 inhibitor, followed sequentially by GM-CSF and thymopentin, HER2-positive patients also receive RC48 antibody-drug conjugate (disitamab vedotin). Mechanisms: Radiotherapy induces tumor death and immunogenic signaling (antigen release, cGAS-STING). PD-L1 inhibitor (monoclonal antibody immune-checkpoint blocker) restores T-cell activation via PD-1/PD-L1 axis. GM-CSF (cytokine) expands/activates dendritic and myeloid cells to enhance antigen presentation. Thymopentin (thymic peptide) promotes T-cell maturation/function. RC48-ADC (anti-HER2 mAb linked to MMAE microtubule toxin) kills HER2-expressing tumor cells with bystander effect. Targets/cells: HER2+ tumor cells, T lymphocytes, dendritic cells/monocytes, PD-1/PD-L1 checkpoint, GM-CSF receptor–myeloid pathway, microtubules, innate cGAS-STING and antigen-presentation pathways.