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

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

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

Inclusion Criteria:

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

Exclusion Criteria:

1. Liver function classified as Child-Pugh C, unimprovable with hepatoprotective therapy;
2. Massive or diffuse hepatocellular carcinoma;
3. Presence of vascular tumor thrombus or invasion of adjacent organs;
4. History of esophageal (gastric fundus) variceal rupture and bleeding within 1 month prior to treatment;
5. Uncorrectable coagulation dysfunction and severe hematological abnormalities, with a high risk of severe bleeding;
6. Refractory massive ascites, cachexia;
7. Active infection, especially inflammatory conditions of the biliary system;
8. Severe functional failure of major organs such as liver, kidney, heart, lung, and brain;
9. Impaired consciousness, or inability to cooperate with treatment;
10. 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);
11. Any other factors deemed by the investigator to make the subject unsuitable for participation or to affect the subject's involvement in the study.