eligibility_summary
Adults (≥18) with MSS metastatic colorectal adenocarcinoma, ECOG 0–1, life expectancy ≥3 mo, measurable disease, no perforation/fistula, adequate organ function. Phase I: 0–2 prior lines, Phase II: no prior metastatic therapy (adjuvant FOLFOX relapse >12 mo). Exclude: prior immunotherapy, immunosuppression/autoimmune disease, transplant, recent major surgery, oxaliplatin allergy, uncontrolled HTN/CV/VTE, obstruction, active brain mets, uncontrolled infections (COVID/HBV/HCV), ILD, neuropathy ≥2, pregnancy, contraception required.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05627635 tests 3B-FOLFOX in MSS metastatic colorectal cancer: FOLFOX (5‑fluorouracil, antimetabolite inhibiting thymidylate synthase, leucovorin, folinic acid that stabilizes TS inhibition, oxaliplatin, platinum DNA crosslinker) plus bevacizumab (anti‑VEGF‑A monoclonal antibody, anti‑angiogenic) with balstilimab (anti‑PD‑1 IgG4 monoclonal antibody, checkpoint inhibitor) and botensilimab (Fc‑enhanced anti‑CTLA‑4 monoclonal antibody, checkpoint inhibitor). Targets/pathways: tumor cell DNA synthesis/repair (TS inhibition, DNA crosslinks), tumor vasculature/endothelial cells via VEGF/VEGFR blockade, adaptive immunity by releasing PD‑1 brake on effector T cells and blocking CTLA‑4 to boost T‑cell priming and deplete intratumoral Tregs. Goal: convert immunologically “cold” MSS mCRC to responsive via chemo + anti‑angiogenic + dual checkpoint synergy.