The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD Background: a Dual Arm, Multicenter, Randomized Controlled Study
This research plan involves a treatment approach for advanced hepatocellular carcinoma (HCC) in the context of metabolic-associated steatotic liver disease (MASLD). The study aims to compare the efficacy differences between sequential therapy and concurrent therapy using bevacizumab and atezolizumab for advanced HCC in MASLD. The research will focus on evaluating objective response rates, progression-free survival, disease control rates, and overall survival, while utilizing biomarker analysis to elucidate treatment mechanisms. Additionally, the study will examine treatment safety, including the incidence and severity of adverse events.
• Age ≥ 18 years old (gender not limited)
• ECOG performance status of 0-1
• Preoperative imaging diagnosis of advanced hepatocellular carcinoma (BCLC stage C or D, unsuitable for surgery)
• Ultrasound or MRI indicating moderate to severe fatty liver (Fibroscan CAP \> 268 dB/m or MR fat score \> 10%)
• Willing to use contraceptive measures during the trial period
• Expected survival time ≥ 3 months
• At least one measurable lesion (per RECIST 1.1) that has not been irradiated
• Organ function levels (within 7 days before first study medication) must meet the following:
• Hematopoietic function: ANC ≥ 1.5×10⁹/L, PLT ≥ 100×10⁹/L, Hb ≥ 90 g/L, no transfusion within 14 days
• Liver function: TBIL ≤ 1.5×ULN, AST/ALT/ALP ≤ 2.5×ULN, serum creatinine ≤ 1.5×ULN, CrCl ≥ 50 mL/min, ALB ≥ 30 g/L, Child-Pugh A
• Coagulation function: INR and APTT ≤ 1.5×ULN or within therapeutic range if on anticoagulants
• Renal function: urinary protein ≤ 1+ (or ≤1 g/24h if \>1+)
• Cardiac function: ECG normal or clinically insignificant, LVEF \> 50%
• Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dosing
• Men and women of reproductive potential must use effective contraception during and for 12 months after treatment
• Participants must voluntarily provide informed consent and have good compliance