OncoMatch/Clinical Trials/NCT05377034
Multinational Phase II Trial to Compare Safety and Efficacy of SIRT (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab, vs SIRT (SIRT-Y90) Followed by Placebo in Locally Advanced HCC Patients
Is NCT05377034 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies SIRT-Y90 with Atezolizumab + Bevacizumab for locally advanced hepatocellular carcinoma.
Treatment: SIRT-Y90 with Atezolizumab + Bevacizumab — This is a multi-national, phase II, parallel-arm, double-blind, placebo-controlled, two-arm study designed to assess the efficacy and safety of SIRT-Y90 followed by atezolizumab plus bevacizumab \[study arm\], versus SIRT-Y90 followed by placebo \[control arm\] in patients with locally advanced Hepatocellular Carcinoma (HCC).
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy to the liver
No prior radiation to the liver
Cannot have received: systemic adjuvant or neoadjuvant therapy
No prior systemic adjuvant or neoadjuvant therapy for HCC
Cannot have received: hepatic artery directed therapy
Exception: ≤2 administrations allowed; must be ≥4 weeks prior to ICF signing
Patients who have had >2 administrations of hepatic artery directed therapy; Patients who have had hepatic artery directed therapy done <4 weeks prior to date of ICF signing
Cannot have received: immunotherapy (interferon-alfa, peginterferon alfa-2a, peginterferon alfa-2b, thymosin-α1)
Exception: none within 30 days prior to randomization, not currently receiving, not planned during study
any immunotherapy (including interferon-alfa, peginterferon alfa-2a, peginterferon alfa-2b, thymosin-α1, etc.) within 30 days prior to randomization, is currently receiving immunotherapy or is planned to start immunotherapy during the study
Lab requirements
Blood counts
Lymphocyte count ≥ 0.5 x 10**9/L (500/μL); Platelets ≥75,000/μL without transfusion; Hemoglobin >9.5 g/dL (transfusion allowed); INR and aPTT ≤ 2.0 x ULN (if not on anticoagulation); Absolute Neutrophil Count ≥1.5×10**9/L without G-CSF support
Kidney function
Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 30 mL/min (Cockcroft-Gault)
Liver function
Serum bilirubin ≤ 3 x ULN; ALP ≤5×institutional ULN; AST and ALT ≤5×institutional ULN; Albumin ≥2.8 g/dL; Child-Pugh A (up to 6 points)
Adequate hematological, renal, and hepatic function as follows: Lymphocyte count ≥ 0.5 x 10**9/L (500/μL); Platelets ≥75,000/μL without transfusion; Hemoglobin >9.5 g/dL (Patients may be transfused to meet this criterion.); Serum bilirubin ≤ 3 x ULN; INR and aPTT ≤ 2.0 x ULN; ALP ≤5×institutional upper limit of normal; AST and ALT ≤5×institutional upper limit of normal; Albumin ≥2.8 g/dL; Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 30 mL/min (Cockcroft-Gault); Absolute Neutrophil Count ≥1.5×10**9/L without G-CSF support; Urine dipstick for proteinuria <2+ at screening; 24-hour urine protein <1g if ≥2+ on dipstick
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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