This protocol addresses patients with a solitary early-stage hepatocellular carcinoma measuring 5 cm or less who are ineligible for or declining surgical resection, and who have received local ablative therapy but did not achieve the required endpoint on post-treatment imaging.
Patients with a solitary hepatocellular carcinoma ≤5 cm who cannot undergo or decline surgery are candidates for curative-intent local ablation. When post-ablation contrast-enhanced imaging shows viable residual tumor — indicating that complete response was not achieved — the clinical situation calls for a structured next step.
The prior line was local ablative therapy with curative intent — thermal ablation (radiofrequency or microwave) as the preferred approach for tumors ≤3 cm, with targeted radioembolization or external beam radiation therapy (including stereotactic body radiation or proton beam) as alternatives, including for tumors larger than 3 cm. The therapeutic goal was complete response with no viable residual tumor on post-ablation contrast-enhanced imaging. Failure to reach this endpoint is the indication for the next-line protocol.