The Safety, Efficacy, and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors

Prior treatment

• Previous or coexisting malignancies.
• Current enrollment in another clinical trial or prior exposure to experimental therapies.

Other illness

• Uncorrectable coagulation dysfunction or severe hematologic abnormalities with a high risk of bleeding.
• Active bacterial infection or fungal infection.
• History of solid organ transplant or hepatic encephalopathy.

Other

• Diffuse hepatocellular carcinoma (HCC), or with tumor thrombus in the main portal vein to secondary branches or hepatic veins.
• Severe liver atrophy or excessively large tumor volume requiring ablation of ≥1/3 of the liver volume.
• Pregnant or breastfeeding, or preparing to pregnant.
• Not suitable to participate in clinical trials judged by investigator.

• Age of 18-80 years.
• Clinical diagnosis or pathologic of hepatocellular carcinoma (HCC) or metastatic liver cancers.
• Intrahepatic lesions with a diameter of ≤5cm, and the number of lesions ≤5.
• Without extrahepatic metastases; for patients with liver metastases, previously underwent radical resection of the primary lesion without local recurrence.
• Child-Pugh score ≤7 (Class A or B).
• Performance status 0-1 (Eastern Cooperative Oncology Group classification).
• Life expectancy of at least 3 months.
• Patients who have previously undergone surgery, chemotherapy, targeted therapy, ablation, vascular interventional therapy (TACE, D-TACE, HAIC), or immunotherapy, with an interval of ≥3 weeks since the last treatment.
• The functional level of major organs must meet the following requirements:
  • (1) Blood Routine: WBC≥3.0×109/L，ANC≥1.5×109/L，PLT≥50×109/L，HGB≥90 g/L. (2) Liver Function: AST ≤5.0×ULN, ALT ≤5.0×ULN, TBIL ≤2.0×ULN. (3) Renal Function: Cr ≤1.5×ULN or CrCl ≥60 mL/min. (4) Coagulation Function: INR ≤1.5; APTT ≤1.5×ULN. (5) HBV-DNA: HBV-DNA ≤2×10³ IU/mL (\*Patients with HBV-DNA \>2×10³ IU/mL may be enrolled but must receive antiviral therapy.\*)