eligibility_summary
Inclusion: 18–75, unresectable locally advanced/metastatic colorectal adenocarcinoma, ECOG 0–1, HER2+ (IHC 3+ >50% or IHC 2+ with FISH ≥2.0), adequate organ function, failed oxaliplatin/irinotecan/5‑FU or intolerant, measurable disease. Exclusion: GI obstruction/bleed/perf, major surgery <4 wks, heart disease (CAD/MI <12 mo or CHF ≥II), thromboembolism <6 mo, HIV, active HBV/HCV, autoimmune disease needing immunosuppression, ILD/pneumonitis, prior PD‑1/PD‑L1/CTLA‑4, pregnant/lactating.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm trial in HER2-positive metastatic colorectal cancer testing: 1) Disitamab vedotin (RC48), an anti-HER2 antibody–drug conjugate delivering the microtubule inhibitor MMAE, 2) Tislelizumab, an anti–PD-1 IgG4 immune checkpoint inhibitor, 3) Low-dose capecitabine, an oral 5-FU prodrug antimetabolite inhibiting thymidylate synthase, 4) Celecoxib, a COX-2–selective NSAID. Targets/pathways: HER2 (ERBB2) on tumor cells → ADC internalization and microtubule disruption, PD-1 on T cells → restores antitumor T-cell activity, thymidylate synthase/DNA synthesis in proliferating tumor cells, COX-2/PGE2 inflammatory signaling in tumor/microenvironment. Strategy combines direct cytotoxicity with immune activation and suppression of tumor-promoting inflammation.