Carcinoma, Hepatocellular
Conditions
Interventions
experimental group:Surgical resection after neoadjuvant treatment with TACE combined with camrelizumab and apatinib
control group:surgical resection without neoadjuvant treatment
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 an informed consent form. 2.Age between 8 and 75 years; no gender restrictions. 3.Patients with initially diagnosed and untreated solitary massive hepatocellular carcinoma (diameter = 10 cm), without vascular invasion or extrahepatic metastasis, confirmed by histopathology or cytology, or meeting the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2022 edition). Presence of resectability criteria:Adequate residual liver volume, i.e., residual liver volume in patients with cirrhosis must be at least 40% of the standard liver volume, and in non-cirrhotic patients, it must be at least 30% of the standard liver volume. 4.Good liver function and liver reserve function: Child-Pugh class A; ICGR 15 < 20%. 5.Adequate hematological and major organ function, defined by the following laboratory results obtained within 7 days before treatment: (1) Neutrophil count = 1.5 ×10^9/L, Hb = 90g/L, PLT = 75 ×10^9/L without the use of colony-stimulating factors or transfusion support; (2) AST, AST, ALP = 5X the upper limit of normal (ULN), TB = 2X ULN, serum albumin = 30g/L; (3) Serum creatinine = 1.5X ULN or creatinine clearance = 50 mL/min; (4) International normalized ratio (INR) = 1.25 and activated partial thromboplastin time (APTT) = 2X ULN; (5) Urine protein < 2+ on routine urinalysis; (6) Thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may still be eligible. 6. ECOG performance status score of 0 or 1.
Exclusion criteria
Exclusion criteria: 1.Known cases of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. 2.HIV infection or autoimmune diseases. 3.A history of severe allergies to any monoclonal antibodies or investigational drug components. 4.Currently participating in other clinical trials, or less than 30 days since the end of treatment with an investigational drug in a previous clinical study. 5.Pregnant or lactating women. 6.Other factors that could potentially affect study outcomes or lead to its early termination (alcohol, drug abuse, serious medical condition, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year overall survival rates;3-year overall survival rates;3-year recurrence-free survival; | — |
Countries
China
Contacts
Public ContactPeng Wei
West China Hospital, Sichuan University
Outcome results
None listed