Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies

Inclusion criteria

• Age 18-80 years, regardless of gender;
• Histopathologically confirmed or clinically diagnosed hepatic malignancies, including primary liver cancer and metastatic liver cancer;
• Presence of an image-evaluable target lesion for ablation, with the maximum diameter of the target lesion being 3-5 cm;
• Patient is intolerant to or refuses surgical resection;
• ECOG performance status score ≤ 2, with an expected survival period of greater than 3 months.

Exclusion criteria

• Liver function classified as Child-Pugh C, unimprovable with hepatoprotective therapy;
• Massive or diffuse hepatocellular carcinoma;
• Presence of vascular tumor thrombus or invasion of adjacent organs;
• History of esophageal (gastric fundus) variceal rupture and bleeding within 1 month prior to treatment;
• Uncorrectable coagulation dysfunction and severe hematological abnormalities, with a high risk of severe bleeding;
• Refractory massive ascites, cachexia;
• Active infection, especially inflammatory conditions of the biliary system;
• Severe functional failure of major organs such as liver, kidney, heart, lung, and brain;
• Impaired consciousness, or inability to cooperate with treatment;
• Previous systemic treatments (e.g., chemotherapy) with an interval of less than 2 weeks and not having recovered from prior treatment: CTCAE 6.0 grade >1 (except for alopecia);
• Any other factors deemed by the investigator to make the subject unsuitable for participation or to affect the subject's involvement in the study.