Hepatocellular Carcinoma Exceeding Milan Criteria — Downstaging for Liver Transplantation
This protocol covers transplant-eligible patients with hepatocellular carcinoma whose initial tumor burden exceeds Milan criteria but falls within UNOS downstaging criteria, with no vascular invasion or extrahepatic spread.
Clinical Scenario
Tumor burden meeting UNOS downstaging criteria: a single lesion 5.1–8 cm; or 2–3 lesions each ≤ 5 cm with sum of diameters ≤ 8 cm; or 4–5 lesions each ≤ 3 cm with sum of diameters ≤ 8 cm. No vascular invasion. No extrahepatic disease. Patient is otherwise transplant-eligible.
Treatment Approach (Overview)
The strategy centres on locoregional therapy to reduce viable tumor burden, followed — after a mandatory period of confirmed disease stability — by liver transplantation. Which locoregional modalities apply, how response is assessed, and the full decision pathway are detailed in the complete protocol.
Full regimen, sequencing, and eligibility checkpoints available via the link below.
Treatment Goals
- Reduction of viable tumor to within Milan criteria (1 lesion ≤ 5 cm, or 2–3 lesions each ≤ 3 cm)
- Reduction of AFP to < 500 ng/ml in patients with prior AFP > 1,000 ng/ml
References
DOI: 10.1097/HEP.0000000000000466
- Patients who are otherwise transplant-eligible except with initial tumor burden exceeding the Milan criteria, especially those meeting UNOS downstaging criteria, should be considered for LT following successful downstaging to within Milan criteria after a 3-to-6-month period of observation (Level 2, Strong Recommendation).
- Tumor downstaging is defined as a reduction in the size of viable tumor using LRT to meet acceptable LT criteria.
- Residual tumor size and diameter within Milan criteria (1 lesion ≤ 5 cm, 2–3 lesions ≤ 3 cm)
- Patients with AFP > 1000 ng/ml must be downstaged to AFP < 500 ng/ml to be considered downstaged (Level 2, Strong Recommendation).
View source ↗