SBRT Plus Systemic Therapy vs Systemic Therapy Alone in BCLC C Hepatocellular Carcinoma
Systemic Therapy Combined With Stereotactic Body Radiotherapy Versus Systemic Therapy Alone in BCLC Stage C Hepatocellular Carcinoma (SCRATCH): A Prospective, Multicenter, Phase II, Randomized Controlled Trial
Shandong Cancer Hospital and Institute
184 participants
Nov 30, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria12
- 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.
- For experimental arm candidates: active lesion count (when PET-CT used) ≤10.
- If prior initial systemic therapy given: intrahepatic disease stable ≥3 months.
- Effective contraception from consent through 1 year after treatment end.
- Ability to understand and sign consent.
Exclusion Criteria10
- 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).
- Severe organ dysfunction precluding treatment.
- Uncontrolled comorbidities (e.g., uncontrolled diabetes, active peptic ulcer, severe cardiopulmonary disease).
- Active uncontrolled infection or active autoimmune disease requiring systemic therapy.
- Significant neurologic dysfunction.
- Pregnant or breastfeeding women; no effective contraception.
- Known hypersensitivity to planned drugs.
- Any other condition making participation unsuitable per investigator.
Interventions
Systemic therapy will consist of the continuation of the guideline-recommended systemic treatment received prior to enrollment, in accordance with approved labels and national guidelines
portal vein tumor thrombus (PVTT, if present) and/or limited extrahepatic active lesions. For patients presenting with more than 10 lesions at baseline (including extrahepatic metastases with or without portal vein tumor thrombus), a comprehensive FDG-PET/CT reassessment of the whole body is required after 3 months of systemic therapy. Patients who demonstrate ≤10 active lesions at this reassessment may then be considered eligible for SBRT. Dose and fractionation: total dose 25-40 Gy delivered in 5 fractions (5-8 Gy per fraction). Dose selection individualized based on tumor size, location and nearby organ-at-risk constraints; sequential or staged SBRT allowed.
Locations(1)
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NCT07274774