Lenvatinib Combined With TACE and Camrelizumab in Conversion Resection for Advanced Hepatocellular Carcinoma (LEN-TAC Study)

Prior treatment

• Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
• Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.
• Systemic glucocorticoid or immunosuppressive therapy within 7 days prior to the first dose.
• Vaccination with live vaccines within 30 days prior to the first dose.

Other illness

• Known hypersensitivity to lenvatinib ingredients.
• Known hypersensitivity to the active ingredient or excipients of Camrelizumab.
• Presence of other malignancies.
• Abnormal coagulation function or bleeding tendency.
• History of psychiatric disorders or substance abuse.
• HIV infection.
• Active infection.
• Active chronic hepatitis B or C.

Lab values

• Class II or higher myocardial ischemia or infarction, poorly controlled arrhythmia, cardiac insufficiency class III-IV, or LVEF \< 50%.

Other

• Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular carcinoma, and fibrolamellar cell carcinoma.
• Extrahepatic metastasis of HCC.
• Diffuse HCC or intrahepatic tumor burden ≥ 50% (including contralateral portal vein tumor thrombus, superior mesenteric vein tumor thrombus, and inferior vena cava tumor thrombus).
• Contraindications to TACE or epirubicin.
• Pregnancy, lactation, or unwillingness to use effective contraceptive measures.
• Poor compliance such as floating population.
• Clinically uncontrolled pleural/peritoneal effusion.

• Aged between 18 and 75 years.
• Patients with HCC who strictly meet the criteria outlined in the Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2022Edition), or those diagnosed by histopathology or cytology.
• No prior anticancer therapy for HCC(Excluding patients who have received two or fewer TACE treatments).
• ECOG PS score of 0-1.
• Child-Pugh class A to B.
• BCLC stage C Patients: tumor localized in one half of the liver with portal vein tumor thrombus (Vp1-Vp4 patients without contralateral portal vein tumor thrombus).
• At least one radiographically measurable lesion according to mRECIST.
• For HBsAg-positive patients, HBV-DNA \< 2000 IU/ml (10\^4 copies/ml) when undergoing PD-1 monoclonal antibody treatment; HCV RNA negative when HCV antibody is positive.
• Adequate organ function based on laboratory test results.
• Adequate blood pressure control with up to 3 antihypertensive agents, defined as BP ≤ 150/90 mmHg at screening with no changes in antihypertensive therapy within 1 week prior to Cycle 1/Day 1.
• Patients expected to survive more than 3 months.
• Not planning to become pregnant.