OncoMatch/Clinical Trials/NCT07293468
Comparison of SBRT and SIRT With Combination IO for Locally-advanced, Unresectable HCCs (BIIRTH)
Is NCT07293468 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies Atezolizumab & Bevacizumab for hepatocellular carcinoma (hcc).
Treatment: Atezolizumab & Bevacizumab — The goal of this clinical trial is to compare the safety and efficacy of sequential Transarterial Chemoembolization (TACE) and Stereotactic body radiation therapy (SBRT) versus Y90-radioembolisation (SIRT), followed by systemic therapy in patients with large, locally advanced, unresectable Hepatocellular carcinoma (HCC). The main question it aims to answer is whether Sequential TACE-SBRT potentially gives longer Progression-free survival (PFS) benefit with similar toxicities as compared with Y90 SIRT. Participants will be recruited via multidisciplinary meetings (MDTs) with hepatobiliary surgeons, medical hepatologists and radiologists with consistent, strict considerations on eligibility and treatment alternatives. Eligible patients will be randomized in 1:1 ratio to received one of the two treatment arms.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage B2, B3, B4
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: locoregional therapy (TACE, RT to liver, SIRT)
Received prior non-curative locoregional (including TACE, RT to liver, SIRT) or systemic therapy received for HCC
Cannot have received: systemic therapy
Received prior non-curative locoregional (including TACE, RT to liver, SIRT) or systemic therapy received for HCC
Cannot have received: anti-PD-1 therapy
Prior treatment with any anti-programmed cell death protein-1 (anti-PD-1), PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent, or an antibody targeting other immune-regulatory receptor(s) or mechanism(s)
Lab requirements
Blood counts
Haemoglobin ≥9 g/dL; Absolute neutrophil count ≥1,500/uL; Platelet count ≥100,000/L
Kidney function
Calculated creatinine clearance (eGFR) ≥45 mL/minute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance
Liver function
Total bilirubin ≤2.0 x ULN; Albumin ≥2.8 g/dL; ALT ≤3 x ULN; INR ≤1.6; Child Pugh (CP) score of A5-B7; Indocyanine green test >15% [unresectable]; Liver volume minus intrahepatic gross tumour volume (GTV) with >700cc
Adequate organ and marrow functions, as listed below: Haemoglobin ≥9 g/dL; Absolute neutrophil count ≥1,500/uL; Platelet count ≥100,000/L; Total bilirubin ≤2.0 x ULN; Albumin ≥2.8 g/dL; ALT ≤3 x ULN; INR ≤1.6; Calculated creatinine clearance (eGFR) ≥45 mL/minute
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07293468 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.
What disease stage is eligible?
Stage B2 or B3 or B4 is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
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