SBRT Plus Systemic Therapy vs Systemic Therapy Alone in BCLC C Hepatocellular Carcinoma

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

Trial Details

NCT ID

NCT07274774

Phase

PHASE2

Sponsor

Shandong Cancer Hospital and Institute

Status

RECRUITING

Cancer Type

Liver Cancer

Interventions

Systemic therapy
Radiotherapy

Locations (sample)

Jinan, Shandong, China|36.66833,116.99722

Key Eligibility 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).

For full eligibility, visit ClinicalTrials.gov.

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