| HCC exceeding Milan criteria but meeting one of the following: |
Single lesion 5.1–8 cm 2–3 lesions each ≤ 5 cm with the sum of the maximal tumor diameters ≤ 8 cm 4–5 lesions each ≤ 3 cm with the sum of the maximal tumor diameters ≤ 8 cm
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| AND absence of vascular invasion or extrahepatic disease based on cross-sectional imaging |
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Criteria for successful downstaging
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| Residual tumor size and diameter within Milan criteria (1 lesion ≤ 5 cm, 2–3 lesions ≤ 3 cm) |
Only viable tumor(s) are considered; tumor diameter measurements should not include the area of necrosis from tumor-directed therapy. If there is more than one area of residual tumor enhancement, then the diameter of the entire lesion should be counted toward the overall tumor burden.
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Criteria for downstaging failure and exclusion from liver transplant
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Progression of tumor(s) to beyond inclusion/eligibility criteria for downstaging (as defined above) Tumor invasion of a major hepatic vessel based on crosssectional imaging Lymph node involvement by tumor or extrahepatic spread of tumor Infiltrative tumor growth pattern Persistent AFP elevations > 500 ng/ml in patients who had prior AFP ≥ 1000 ng/ml
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Timing of liver transplant in relation to downstaging
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There should be a minimum observation period of 3 mo of disease stability from successful downstaging to liver transplant Per current UNOS policy, the patient must remain within Milan criteria for 6 mo after successful downstaging before receiving MELD exception points
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