eligibility_summary
Eligibility: Advanced HCC confirmed by pathology or AASLD, prior exposure, progression, or intolerance to TKIs/ICIs/chemo/VEGF mAb or combos, Child-Pugh A or B (≤7), BCLC B/C or CNLC III, ≥1 measurable lesion (mRECIST v1.1), EGFR positive, RAS wild-type. Exclude: cholangiocarcinoma/mixed/fibrolamellar, hepatic encephalopathy ≤6 mo, high-risk varices or variceal bleed ≤6 mo, symptomatic brain/leptomeningeal mets unless treated >3 mo and stable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06413017 is a phase II, single-arm study in advanced HCC after first-line failure, testing: 1) Nimotuzumab (h-R3): a humanized IgG1 monoclonal antibody against EGFR. Mechanism: blocks ligand (EGF/TGF-α) binding to EGFR, inhibiting downstream RAS/RAF/MEK/ERK and PI3K/AKT signaling, may also mediate ADCC. Dosing: 400 mg IV weekly. 2) Immune checkpoint inhibitors (ICIs): anti–PD-1 or anti–PD-L1 monoclonal antibodies, blocking the PD-1/PD-L1 axis to restore T-cell activation and antitumor cytotoxicity. Targets/cells/pathways: EGFR-positive, RAS wild-type HCC tumor cells (EGFR/HER1 signaling), PD-1 on T cells and PD-L1 on tumor/immune cells in the tumor microenvironment (immune checkpoint pathway), aiming to inhibit tumor growth and relieve immunosuppression.