Targeted radiation (SBRT) after TACE for liver cancer
Official title: Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma
Run by RWTH Aachen University · NCT04996914 · Data updated 2026-11-12
This study tests whether adding stereotactic body radiation therapy (SBRT) after trans-arterial chemoembolization (TACE) helps people with early or intermediate hepatocellular carcinoma who cannot have surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | RWTH Aachen University Academic / other |
| Locations | 1 site (Aachen, North Rhine-Westphalia) |
| Status | Recruiting |
| Started | May 5, 2026 |
| Main results expected | May 5, 2028 |
| Study ends | May 5, 2029 |
| Registry record updated | May 11, 2026 |
| Trial ID | NCT04996914 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–80 with 1–3 non-resectable HCC lesions (single or combined size ≥4 cm), Child–Pugh A or selected B, BCLC A–B, adequate non-tumor liver volume and lab values, who are ineligible for or have declined surgery or transplant.
✕Probably not a fit
Patients with extrahepatic metastases, macroscopic vascular invasion, arterio-portal or arterio-venous fistulas, prior SIRT, recent sorafenib, prior other malignancies, or who are pregnant or breastfeeding are excluded and unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial enrolls adults with early or intermediate stage hepatocellular carcinoma (BCLC A or B) who are not candidates for surgical resection or transplant and have one to three liver lesions totaling at least 4 cm. Participants receive trans-arterial chemoembolization (TACE) followed by stereotactic body radiation therapy (SBRT) targeted to the treated lesions. Eligibility requires adequate liver reserve (Child–Pugh A5–6 or selected B7–8), sufficient non-tumor liver volume, and acceptable blood counts and kidney function, while patients with extrahepatic disease or macroscopic vascular invasion are excluded. Patients will be followed for local tumor control, liver-related toxicity, and clinical outcomes over time.
Why it matters
Potential benefit: If successful, adding SBRT after TACE could improve local tumor control and delay disease progression, potentially extending time before systemic therapy is needed.
How similar studies have gone: Smaller and non-randomized studies have suggested SBRT after TACE can improve local control, but high-quality randomized evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * HCC (diagnosis: histological or radiological) * Age: 18-80 * Number of lesions 1-3 lesions * Size of the lesion (or sum of 2-3 lesions) ≥ 4 cm * Sufficient non-tumorous liver volume (≥ 800 cm3) * Child Pugh Score: A5-6 or B7-8 * BCLC A or B * Patient is illegible or refused surgical resection or orthotopic liver transplant * Blood work (within 2 weeks before registration): * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³) * Platelets ≥50,000 cells/mm³ * AST (and ALT) \< 5 times ULN * Serum creatinine ≤ ULN or creatinine clearance ≥ 50 mL/min Exclusion Criteria: * Evidence of extrahepatic disease (lymph node or distant metastases) * Evidence of macroscopic vascular invasion * Evidence of an arterio-portal or arterio-venous fistulas * History of previous malignancy * Previous SIRT * Previous Sorafenib in the last 8 weeks * Pregnant and lactating females
Where it's running
-
RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, Germany Recruiting
Study contacts
- Study coordinator: Ahmed Allam Mohamed, MBBS,MSc, MD
- Email: amohamed@ukaachen.de
- Phone: +49241 80-8926
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.