Hepatocellular carcinoma
Conditions
Interventions
Experimental group:Neoadjuvant TACE Combined with Camrelizumab and Apatinib
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years, inclusive, regardless of gender. 2. Newly diagnosed central hepatocellular carcinoma (HCC): (1) Tumor located within 1 cm of major vascular structures (including main portal vein branches, main hepatic veins, and inferior vena cava), situated in Couinaud segments I, IV, V, or VIII, or at the junction of these segments; (2) At least one measurable lesion; (3) Pathologically confirmed via percutaneous liver biopsy, or clinically diagnosed based on typical radiological features, with final confirmation through multidisciplinary team (MDT) discussion. 3. Resectability criteria: (1) Future liver remnant (FLR) volume >40% of standard liver volume in patients with cirrhosis; (2) FLR volume >30% of standard liver volume in patients without cirrhosis. 4. Adequate liver function: (1) Child-Pugh class A; (2) ICG R15 =1.5×10^9/L, Hb >=90 g/L, PLT >=75×10^9/L, without the use of colony-stimulating factors or transfusion support; (2) AST, ALT, ALP =30 g/L; (3) Serum creatinine =50 mL/min; (4) International normalized ratio (INR) <=1.25 and activated partial thromboplastin time (APTT) <=2× ULN; (5) Urinalysis showing urine protein <2+; (6) Thyroid-stimulating hormone (TSH) within normal range (if baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within normal range may still be enrolled).
Exclusion criteria
Exclusion criteria: 1. Indistinct tumor margins; 2. History of other malignancies; 3. Presence of tumor thrombus in the portal vein/inferior vena cava and their branches; 4. Lymph node metastasis or extrahepatic metastasis; 5. Human immunodeficiency virus (HIV) infection, or presence of autoimmune diseases; 6. Known history of severe allergy to any monoclonal antibody or excipients of the investigational drug; 7. Current participation in other clinical trials, or less than 30 days between the last dose of previous clinical trial medication and the first dose in this study; 8. Pregnant or lactating women; 9. Other factors deemed by the investigator as potentially affecting the study results or leading to premature termination of the study, such as alcoholism, drug abuse, substance addiction, comorbid severe diseases (including psychiatric disorders) requiring treatment, significant laboratory abnormalities, or familial/social circumstances that may compromise medication safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response (MPR) rate;Overall survival (OS);Pathological complete response(PCR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) ;Adverse events and serious adverse events ;R0 resection rate;Event-free survival (EFS); | — |
Countries
China
Contacts
Public ContactPeng Wei
West China Hospital, Sichuan University
Outcome results
None listed