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RecruitingPhase 2, Phase 3NCT07285850

The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD

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Trial Parameters

ConditionHCC - Hepatocellular Carcinoma
SponsorEastern Hepatobiliary Surgery Hospital
Study TypeINTERVENTIONAL
PhasePhase 2, Phase 3
Enrollment20
SexALL
Min Age18 Years
Max AgeN/A
Start Date2025-10-20
Completion2026-08-30
Interventions
Sequential treatment of bevacizumab combined with atezolizumab (sequential group)Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)

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Brief Summary

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.

Eligibility Criteria

Eligibility Criteria Inclusion Criteria * 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

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