eligibility_summary
Adults 18–75 with consent, biopsy‑proven locally advanced rectal adenocarcinoma ≤10 cm from anal verge, RAS/BRAF WT, high‑risk MRI (cT4, EMVI, cN2, MRF involved, enlarged lateral LN), ECOG 0–1, no prior therapy, swallow pills, surgery‑fit, labs adequate, contraception. Exclude allergies to EGFR/PD‑1/capecitabine/platinum, recent steroids/live vaccine/major surgery, autoimmune or immunodeficiency/HIV/transplant, cardiac disease, recent/active infection incl TB, HBV, HCV, pregnancy/breastfeeding, PI judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase II, single-arm in RAS/BRAF–wild type locally advanced rectal cancer. Interventions: 1) Short-course pelvic radiotherapy (25 Gy in 5 fractions, 1 week). Mechanism: induces DNA double‑strand breaks and immunogenic tumor cell death. 2) HLX07: anti‑EGFR monoclonal antibody (biologic). Mechanism: blocks EGFR signaling on tumor cells, suppressing RAS/RAF/MEK/ERK pathway (relevant to RAS/BRAF WT tumors). 3) Serplulimab: anti‑PD‑1 monoclonal antibody checkpoint inhibitor (biologic). Mechanism: blocks PD‑1 to restore T‑cell activation and cytotoxicity. 4) CAPOX chemotherapy: capecitabine (oral 5‑FU prodrug, antimetabolite inhibiting thymidylate synthase) + oxaliplatin (platinum DNA crosslinker). Targets/cells: EGFR on colorectal tumor cells, PD‑1 on T cells, proliferating tumor cells’ DNA synthesis/repair, tumor microenvironment immune activation.