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 (Jun 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
Treatments studied
Immunotherapy
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT05377034 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 99 years or younger and at least 21 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages