Efficacy and Safety of Multimodal Ablation Combined With PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of Unresectable Primary Hepatocellular Carcinoma: A Single-Arm, Single-Center Clinical Study

Prior treatment

• Last anti-tumor therapy (e.g., radiotherapy, systemic chemotherapy, or local treatment) within \<1 month.

Other illness

• Extensive metastatic disease with an expected survival \<3 months.
• Severe dysfunction of major organs (liver, kidney, heart, lung, or brain).
• History of esophageal/gastric variceal bleeding within the past month.
• History of other malignancies.
• Active infection; HBV co-infection (HBV DNA ≥2000 IU/mL or ≥10⁴ copies/mL unless reduced by one log after antiviral therapy); HCV co-infection requiring guideline-directed antiviral treatment; HIV infection; or biliary tract inflammation.
• History of organ transplantation or hepatic encephalopathy.
• Uncorrectable coagulation disorders.
• Any other condition deemed unsuitable by investigators that may affect study participation.

Other

• Child-Pugh class C liver dysfunction.
• Tumor thrombus in the main portal vein or hepatic vein.
• Refractory massive ascites, pleural effusion, or cachexia.
• Pregnancy, impaired consciousness, or inability to comply with treatment.
• High tumor burden (sum of the largest liver lesion diameter and number of liver lesions \>12).

• Age 18-80 years, regardless of gender.
• Clinically or pathologically confirmed HCC.
• CNLC stage IIb-IIIa, deemed unresectable after multidisciplinary evaluation.
• Having radiologically evaluable, untreated target lesions for ablation, with the largest diameter of the target tumor \>5 cm.
• Patients who have not undergone systemic chemotherapy, targeted therapy, or immunotherapy for hepatocellular carcinoma, or those who have been evaluated as SD (stable disease) or PD (progressive disease) after treatment..
• ECOG PS 0-1 and an expected survival \>3 months.
• Child-Pugh score ≤7.