Short-course targeted radiation before liver surgery for a single hepatocellular carcinoma nodule
Official title: A Pilot Study on the Feasibility and Tolerance of Neoadjuvant Hypofractionated, Stereotactic Body Radiation Therapy Prior to Surgical Resection of Uninodular Hepatocellular Carcinoma.
Run by University Hospital, Lille · NCT04587739 · Data updated 2026-11-12
This trial will test whether a short course of focused stereotactic radiation given before surgery helps patients with a single 3–8 cm hepatocellular carcinoma who are candidates for liver resection.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | January 31, 2021 |
| Main results expected | January 2028 |
| Study ends | January 2029 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT04587739 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with a single hepatocellular carcinoma 3–8 cm in size, preserved liver function (Child-Pugh A), good performance status, no portal vein thrombosis or extrahepatic metastases, and who are scheduled for curative liver resection without preoperative portal vein embolization.
✕Probably not a fit
Patients with decompensated cirrhosis (Child-Pugh B/C), multiple tumors, neoplastic portal vein thrombosis, extra-hepatic metastases, poor performance status, or recent anticancer therapy are 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
This is a phase 1 feasibility trial of neoadjuvant hypofractionated stereotactic body radiation therapy (SBRT) delivered prior to planned hepatectomy for patients with a single 3–8 cm hepatocellular carcinoma. Participants receive SBRT to the tumor followed by conventional liver resection with curative intent, and the study will monitor surgical timing, safety, drop-out, and early pathological and radiologic responses. Key eligibility limits include preserved liver function (no Child-Pugh B/C), no portal vein thrombosis or extrahepatic disease, and no recent anticancer therapy. The goal is to determine whether preoperative SBRT is practicable and safe enough to test in larger trials aimed at reducing microscopic spread and recurrence.
Why it matters
Potential benefit: If successful, preoperative SBRT could shrink or sterilize tumor edges and reduce microscopic vascular spread, potentially lowering local recurrence after surgery and allowing less extensive resections.
How similar studies have gone: SBRT is an established local treatment for unresectable HCC, but using hypofractionated SBRT specifically as a planned preoperative (neoadjuvant) approach before resection is relatively novel with limited published feasibility data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biopsy-proven hepatocellular carcinoma or EASL/AASLD criteria * Single nodule, 3 to 8 cm of largest diameter * Hepatocellular carcinoma eligible for conventional liver resection with curative intent (R0), without preoperative portal vein embolization Exclusion Criteria: * Performance status \> 2 * Severe comorbidity with contraindication for either surgery or radiation therapy * Decompensated liver cirrhosis (Child-Pugh B or C) * Neoplastic portal vein thrombosis or extra-hepatic metastases * Previous anticancer therapy within the last 5 years
Where it's running
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Hop Claude Huriez Chu Lille
Lille, France Recruiting
Study contacts
- Principal investigator: Emmanuel Boleslawski, MD,PhD — University Hospital, Lille
- Study coordinator: Emmanuel Boleslawski, MD,PhD
- Email: emmanuel.boleslawski@chru-lille.fr
- Phone: 320444260
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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.