eligibility_summary
Eligibility: Adults 18–75, ECOG 0–1, MSS/pMMR metastatic colorectal cancer with ≤10 mets, ≥1 RT-evaluable lesion (RECIST 1.1), no RT in past 6 mo, Cohort A no prior 1L chemo, Cohort B after/stop 1L, life expectancy ≥24 wks, adequate organ function, not pregnant/lactating. Exclude: prior checkpoint inhibitors, cytopenias, hepatic/renal/coag/electrolyte dysfunction or proteinuria, uncontrolled HTN/effusions, recent thrombosis/bleeding/cardiac disease, other cancer, HBV/HCV/cirrhosis, large brain mets or cord compression.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: PULSAR (personalized ultrafractionated stereotactic adaptive radiotherapy), Sintilimab (anti‑PD‑1 IgG4 monoclonal antibody, immune checkpoint inhibitor), standard systemic therapy: chemotherapy (FOLFOX, FOLFIRI, XELOX, irinotecan, raltitrexed—antimetabolites/platinum/topoisomerase I inhibitor) plus targeted antibodies bevacizumab (anti‑VEGF) or cetuximab (anti‑EGFR, for RAS/BRAF WT). Mechanisms: PULSAR delivers pulsed high‑dose RT causing tumor DNA damage, immunogenic cell death, antigen release, and tumor microenvironment remodeling, sintilimab blocks PD‑1 to reinvigorate cytotoxic CD8+ T cells, chemotherapy debulks and can increase tumor antigenicity, bevacizumab inhibits VEGF‑driven angiogenesis/normalizes vasculature to aid immune entry, cetuximab blocks EGFR signaling and mediates NK‑cell ADCC. Targets/pathways: PD‑1/PD‑L1 on T cells/tumor, VEGF–VEGFR on endothelial cells, EGFR on tumor epithelial cells, DNA/topo I/thymidylate synthase in tumor cells, dendritic cell priming and CD8+ T‑cell responses.