Targeted radiation (SBRT) after TACE for liver cancer
Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | RWTH Aachen University Academic / other |
| Locations | 1 site (Aachen, North Rhine-Westphalia) |
| Trial ID | NCT04996914 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Smaller and non-randomized studies have suggested SBRT after TACE can improve local control, but high-quality randomized evidence remains limited.
Eligibility criteria
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 this trial is running
Aachen, North Rhine-Westphalia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.