Actively Recruiting
SBRT Plus Systemic Therapy vs Systemic Therapy Alone in BCLC C Hepatocellular Carcinoma
Led by Shandong Cancer Hospital and Institute · Updated on 2026-04-28
184
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SBRT Plus Systemic Therapy vs Systemic Therapy Alone in BCLC C Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Histologically or clinically diagnosed hepatocellular carcinoma per national guidelines
- BCLC stage C disease, including portal vein tumor thrombus and/or extrahepatic metastases suitable for study procedures
- Child-Pugh class A or B liver function with a score of 7 or less
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Expected survival of at least 6 months
- Adequate organ function as defined by study protocol
- For participants in the experimental arm: 10 or fewer active lesions when PET-CT is used
- Stable intrahepatic disease for 3 months or more if prior initial systemic therapy was given
- Use of effective contraception from consent through one year after treatment ends
- Ability to understand and sign informed consent
You will not qualify if you...
- Presence of a second primary cancer (with some exceptions)
- Tumor thrombus or metastases that cannot be treated with radiotherapy
- Prior systemic anticancer therapy for current hepatocellular carcinoma (prior local therapies allowed under rules)
- Severe organ dysfunction preventing treatment
- Uncontrolled medical conditions such as diabetes, active peptic ulcer, or severe heart or lung disease
- Active uncontrolled infection or autoimmune disease requiring systemic therapy
- Significant neurological problems
- Pregnancy or breastfeeding without effective contraception
- Known allergy to planned study drugs
- Any other condition deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Actively Recruiting
Research Team
J
Jinbo Yue, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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