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

Inclusion criteria (1)18 to 75 years of age; (2)Patients with HCC who strictly meet the criteria of Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2019 Edition) or are diagnosed by histopathology or cytology; (3)No prior anticancer therapy for HCC; (4)ECOG PS score 0-1; (5)Child-Pugh class A ~ B; (6)BCLC stage C Patients: tumor localized in one half of liver with portal vein tumor thrombus (according to PVTT typing, Vp1 ~ Vp4 patients without contralateral portal vein tumor thrombus); (7)At least one radiographically measurable lesion according to mRECIST; (8)In HBsAg-positive patients, HBV-DNA<2000 IU/ml (10^4 copies/ml) when PD-1 monoclonal antibody treatment is performed; HCV RNA is negative when HCV antibody is positive; (9)Adequate organ function defined by laboratory test results; (10)Adequate blood pressure (BP) control with up to 3 antihypertensive agents, defined as BP≤150/90 mmHg at screening and no change in antihypertensive therapy within 1 week prior to Cycle 1/Day 1. (11)Patients expected to survive more than 3 months. (12)No plans to be pregnant. Exclusion criteria Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular carcinoma, and fibrolamellar cell carcinoma; Extrahepatic metastasis of HCC; Diffuse HCC or intrahepatic tumor burden ≥ 50% (including tumor contralateral portal vein tumor thrombus, superior mesenteric vein tumor thrombus, and inferior vena cava tumor thrombus); Contraindications to TACE or epirubicin; Known hypersensitivity to lenvatinib ingredients; Known hypersensitivity to the active ingredient or excipients of Camrelizumab; With other malignancies; Pregnant or lactating women, or fertile patients who are unwilling or unable to take effective contraceptive measures; Patients with class II or higher myocardial ischemia or myocardial infarction, or poorly controlled arrhythmia (including QTc interval ≥ 470 ms); according to NYHA classification for chronic heart failure, cardiac insufficiency class III-IV, or left ventricular ejection fraction (LVEF) < 50% by echocardiography; Abnormal coagulation function [INR > 1.5 or PT > upper limit of normal (ULN) + 4 seconds or APTT > 1.5 ULN], bleeding tendency or receiving thrombolytic or anticoagulant therapy; History of psychiatric disorders or psychotropic substance abuse; Combined with HIV infected; Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; Patients with active infection; Patients with poor compliance such as floating population; Prior treatment with any of the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 agents, or drugs targeting other T-cell co-stimulatory receptors or co-inhibitory receptors. Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose (the alternative therapy is not considered systemic); Receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose, except for physiological doses of glucocorticoids (≤ 10 mg/day prednisone or equivalent); Presence of clinically uncontrolled pleural/peritoneal effusion (patients who do not require drainage of fluid and who stop receiving drainage for 3 days without significant increase in volume can be included); Acute or chronic active chronic active hepatitis B or C with HBV-DNA ≥ 200,000 IU/ml (or 10^6 copies/ml) or HCV RNA ≥ 10^3 copies/ml when treated with PD-1 monoclonal antibody; Vaccination with live vaccines within 30 days prior to first dose (Cycle 1/Day 1). Inactivated viral vaccines against seasonal influenza within 30 days prior to first dose are permitted, but live attenuated intranasal influenza vaccines are not permitted.