eligibility_summary
Include: metastatic colorectal adenocarcinoma with liver metastases, non‑MSI‑H/dMMR, measurable disease, planned liver resection, agree to tumor testing, not pregnant/breastfeeding, contraception if childbearing potential, no chemo, growth factors, transfusions/albumin ≤14 days. Exclude: not surgical candidate, uncontrolled illness, prior allogeneic transplant, prior checkpoint inhibitor therapy or ICI contraindications, active autoimmune disease needing systemic therapy ≤2y (exceptions).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06300463 tests three perioperative immunotherapy strategies in colorectal cancer liver metastases: (1) Botensilimab + Balstilimab, (2) Botensilimab + Balstilimab + AGEN1423, (3) Botensilimab + Balstilimab + liver radiation. Botensilimab (AGEN1181) is an Fc‑enhanced anti‑CTLA‑4 monoclonal antibody that promotes T‑cell priming and depletes intratumoral Tregs via ADCC, boosting CD8+ T cells. Balstilimab (AGEN2034) is an anti‑PD‑1 monoclonal antibody that blocks PD‑1/PD‑L1 to reinvigorate exhausted T cells. AGEN1423 is a bifunctional TGF‑β/CD73 trap that neutralizes TGF‑β and inhibits CD73‑mediated adenosine immunosuppression, reprogramming the tumor microenvironment. Radiation (8 Gy × 3) induces immunogenic tumor cell death and antigen release. Targets/pathways: CTLA‑4 (Tregs/effector T cells), PD‑1 (T cells), TGF‑β signaling, CD73/adenosine axis, and antigen presentation leading to increased CD8+:Treg ratio.