eligibility_summary
Incl: Metastatic colon adenocarcinoma (not appendix/anal), RAS/BRAF WT, ≥2 prior regimens (1L anti‑EGFR ok if ≥PR and ≥1‑yr off), ECOG 0–1, measurable disease, LE >3 mo, contraception. Excl: prior trifluridine/tipiracil, untreated dMMR/MSI‑H, recent therapy/trial, brain mets, other malignancy, poor GI absorption, effusions, pregnancy/lactation, steroids, ILD, active infection, significant heart disease, HIV/HBV/HCV, unresolved >G1 toxicity, per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06379399 tests trifluridine/tipiracil (TAS‑102) plus cetuximab in third-line+ RAS/BRAF wild-type metastatic colorectal cancer. Trifluridine/tipiracil is an oral cytotoxic antimetabolite: trifluridine (a nucleoside analog) is phosphorylated and incorporated into DNA, disrupting replication and causing tumor cell death, tipiracil inhibits thymidine phosphorylase to prevent trifluridine degradation and increase exposure. Cetuximab is a chimeric IgG1 monoclonal antibody targeting EGFR, blocking ligand binding and downstream signaling and inducing ADCC. Targets/pathways: EGFR on colorectal tumor cells, downstream RAS–RAF–MEK–ERK and PI3K–AKT pathways (in RAS/BRAF WT tumors), and the DNA replication machinery in proliferating cancer cells, ADCC engages immune effector cells (e.g., NK cells).