NCT07274774SuspendedPhase 2
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
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Reason given: Difficult to recruit patients
Brief summary (registry, in English)
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.
- Status (registry)
- Suspended
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 184 (estimated)
- First submitted
- 22 Nov 2025
- Start date
- 30 Nov 2025
- Primary completion date
- 10 Nov 2027
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07274774
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Tumor thrombus/metastases judged not amenable to radiotherapy.
- Prior systemic anticancer therapy for current HCC (prior local therapy permitted per rules).
Other illness
- Second primary malignancy (exceptions apply).
- Uncontrolled comorbidities (e.g., uncontrolled diabetes, active peptic ulcer, severe cardiopulmonary disease).
- Active uncontrolled infection or active autoimmune disease requiring systemic therapy.
- Known hypersensitivity to planned drugs.
- Any other condition making participation unsuitable per investigator.
Other
- Severe organ dysfunction precluding treatment.
- Significant neurologic dysfunction.
- Pregnant or breastfeeding women; no effective contraception.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong Cancer Hospital and Institute | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.