Carcinoma, Hepatocellular
Conditions
Interventions
experimental group:Neoadjuvant Therapy with TACE Combined with Lenvatinib and Tislelizumab Before Surgery and Adjuvant Therapy with Lenvatinib Combined with Tislelizumab After Surgery
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Subjects voluntarily participate in this study and sign the informed consent form; 2) Age between 18 and 75 years; no gender restriction; 3) Newly diagnosed and untreated hepatocellular carcinoma with high-risk factors for recurrence (if a single tumor, tumor diameter > 5 cm; or multiple tumors, with no more than 3 tumors, the largest tumor diameter not exceeding 3 cm, i.e., CNLC stage ?b), without vascular invasion or extrahepatic metastasis, confirmed by pathological histology or cytology, or meeting the clinical diagnostic criteria of the "Guidelines for Diagnosis and Treatment of Primary Liver Cancer" (2022 edition); presence of resectability: sufficient residual liver volume, with residual liver volume in cirrhotic patients accounting for more than 40% of standard liver volume, and in non-cirrhotic patients accounting for more than 30% of standard liver volume; 4) Good liver function and hepatic reserve: Child-Pugh grade A; ICGR 15 < 20%; 5) Good hematologic and major organ function, defined as laboratory results obtained within 7 days before treatment: i. Without colony-stimulating factor or transfusion support, neutrophils = 1.5 × 10^9/L, Hb = 90 g/L, PLT = 75 × 10^9/L; ii. AST, ALT, ALP = 5X upper limit of normal (ULN), TB = 2X ULN, serum albumin = 30 g/L; iii. Serum creatinine = 1.5X ULN or creatinine clearance rate = 50 mL/min; iv. International normalized ratio (INR) = 1.25 and activated partial thromboplastin time (APTT) = 2X ULN; v. Urinalysis shows urinary protein < 2+; vi. Thyroid-stimulating hormone (TSH) within the normal range; if baseline TSH exceeds the normal range, subjects with normal total T3 (or FT3) and FT4 can also be enrolled; 6) ECOG performance status score of 0 or 1.
Exclusion criteria
Exclusion criteria: 1) Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma and hepatocellular carcinoma; 2) Human immunodeficiency virus (HIV) infection, or suffering from autoimmune diseases; 3) Known history of severe allergy to any monoclonal antibody or excipients of the study drug; 4) Currently participating in another clinical study, or less than 30 days since the end of treatment in a previous clinical study before the first dose of this study; 5) Pregnant or breastfeeding women; 6) Other factors that may affect the study results or cause the study to be terminated prematurely, as judged by the investigator, such as alcoholism, drug addiction, substance abuse, other severe diseases (including mental illness) requiring combined treatment, severe laboratory abnormalities, or family or social factors that may affect drug safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) ;R0 resection rate; event-free survival (EFS);overall survival (OS);1-year recurrence-free survival (RFS); | — |
Countries
China
Contacts
Public ContactWei Peng
West China Hospital, Sichuan University
Outcome results
None listed