SBRT Plus Systemic Therapy vs Systemic Therapy Alone in BCLC C Hepatocellular Carcinoma (NCT07274774) | Clinical Trial Compass
RecruitingPhase 2
SBRT Plus Systemic Therapy vs Systemic Therapy Alone in BCLC C Hepatocellular Carcinoma
China184 participantsStarted 2025-11-30
Plain-language summary
This prospective, multicenter, phase II randomized controlled trial compares the efficacy and safety of SBRT combined with systemic therapy versus systemic therapy alone in BCLC stage C hepatocellular carcinoma (HCC). The primary objective is to compare overall survival (OS) between the two arms. Secondary objectives include progression-free survival (PFS), objective response rate (ORR), quality of life (QoL), and incidence and severity of adverse events (AEs). Eligible patients will be randomized 2:1 to an experimental arm (SBRT + systemic therapy) or control arm (systemic therapy alone). Key inclusion criteria include BCLC C disease, Child-Pugh A-B liver function, ECOG ≤2, measurable disease per RECIST 1.1, and stable intrahepatic disease after initial systemic therapy for ≥3 months when applicable. The trial will also include predefined safety monitoring, QoL assessments (EORTC QLQ-C30 and QLQ-HCC18), and exploratory biomarker analyses.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age 18-70 years.
✓. Histologically or clinically diagnosed HCC per national guidelines.
✓. BCLC stage C (CNLC IIIA/IIIB), including PVTT and/or extrahepatic metastases amenable to protocol procedures.
✓. Child-Pugh class A or B (score ≤7).
✓. At least one measurable lesion per RECIST 1.1 (criteria specified).
✓. ECOG ≤2.
✓. Expected survival ≥6 months.
✓. Adequate organ function per protocol thresholds.
Exclusion criteria
✕. Second primary malignancy (exceptions apply).
✕. Tumor thrombus/metastases judged not amenable to radiotherapy.
✕. Prior systemic anticancer therapy for current HCC (prior local therapy permitted per rules).
What they're measuring
1
Overall Survival (OS)
Timeframe: subjects will be followed up for a minimum combined accrual + follow-up period of 48 months (24-month enrollment + 24-month follow-up planned)