A Study Comparing Immunotherapy Alone Versus Immunotherapy Combined With Radiotherapy in Patients With Hepatocellular Carcinoma (HCC) With Vascular Invasion
Trial Parameters
Brief Summary
In the present study, we aim to investigate the efficacy and safety of concurrent therapy of Immunotherapy based combination therapy and Radiotherapy in patients with advanced HCC showing macrovascular invasion.
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent form 2. Age \>= 19 at the time of signing Informed consent form 3. Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association -National Cancer Center 4. Unresectable and/or locally advanced or metastatic disease showing major vascular invasion a. Presence of major vascular invasion on dynamic CT or dynamic MRI (1+2) * an intraluminal filling defect adjacent to the primary tumor in portal vein, hepatic vein, and/or inferior vena cava * an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases 5. Having at least one measurable target lesion (per RECIST v1.1) a. Participants who received prior locoregional therapy (e.g., radiofrequency ablation, microwave ablation, transarterial chemoembolization, transarterial radioembolization, transarterial embolization, radiation therapy etc.) are eligible provided that other target lesion(s) have not been previously treated