Clinical trial · Interventional
Transarterial Chemoembolization Versus Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma
Transarterial Chemoembolization With Drug-Eluting Beads (Standard Arm) Versus Stereotactic Body Radiation Therapy (Experimental Arm) for Hepatocellular Carcinoma: A Multicenter Randomized Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
Rationale: This study will compare head to head in patients with hepatocellular carcinoma (HCC) ineligible for surgery or radiofrequency ablation, the standard treatment arm, transarterial chemoembolization with drug-eluting beads (TACE-DEB), with the experimental arm, stereotactic body radiation therapy (SBRT). The investigators hypothesis is that the time to progression is more favorable after SBRT than after TACE-DEB. The expected time to include the required patients for this trial will be four years. To the best of the investigators knowledge this study will be the first in the world that will compare both techniques in a randomized trial. Objective: To assess the time to progression after TACE-DEB and after SBRT in a comparable population of patients diagnosed with HCC. Study design: Randomized, prospective, open-label, and phase II study. Study population: Patients diagnosed with HCC, Child-Pugh grade A, one to three tumors, cumulative diameter ≤ 6cm, and ≥ 18 years old. Intervention: Patients with HCC will be randomized to receive the standard treatment, TACE-DEB loaded with doxorubicin or the experimental arm, SBRT. Main study parameters/endpoints: The primary endpoint of this study will be time to progression, defined as time from randomization to radiological progression. Secondary endpoints will be: * Time to local recurrence * Response rate (complete and partial response) * Overall survival * Toxicity * Quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemoembolization | Device | — | UNRESOLVED |
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Transarterial chemoembolization
- description
- Chemoembolization will be performed through a transarterial route delivering drug eluting beads, i.e. hydrogel-based microspheres (Biocompatibles UK, Ltd, HepaSphere Biosphere Medical) loaded with the chemotherapeutic agent doxorubicin.
- interventionNames
- Device: chemoembolization
- type
- EXPERIMENTAL
- label
- Stereotactic body radiation therapy
- description
- Risk-adapted dose prescription for delivering the highest possible tumor dose not exceeding the maximum dose in 6 fractions of 8-9 Gy, while hepatic normal tissue complication probability (NTCP) \< of 5%
- interventionNames
- Radiation: Radiation therapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with HCC Patients can be included if they require treatment prior to liver transplantation. * Barcelona Clinic Liver Cancer Stage System class A-B * One to three tumors of maximum cumulative diameter ≤ 6 cm measured in all 3 axes. * Measurable disease to be selected as a target on CT/MRI-scan, according to mRECIST criteria for HCC within 6 weeks prior to randomization (≥ 1cm at least in one dimension, suitable for repeated measurement, and arterial enhancement) \[44\]. * Tumor visibility on CT * Child-Pugh A cirrhosis * Age ≥ 18 years * ECOG performance status 0-1 * Albumin\> 28 g/l, bilirubin \< 50 µmol/l, INR \< 2.3, AST/ALT \< 5 times ULN, within 6 weeks prior to randomization * Platelets will be preferably ≥ 50x10E9/ l (if not, thrombocytes transfusion is allowed to ensure a safe procedure at the discretion of the interventional radiologist and gastroenterologist). Leukocytes \> 1.5x10E9/l, Hb \> 6 mmol/l, within 6 weeks prior to randomization * Written informed consent * Willing and able to comply to the follow-up schedule * Planned to start treatment within 6 weeks from randomization. Exclusion Criteria: * Eligibility for resection or RFA * More than three tumors in the liver * Ascites * Any signs of acute viral or non-viral hepatitis * Encephalopathy * Vascular tumor invasion (contact with the vessel will not be considered contraindication). * Previous radiotherapy to the liver * Known current pregnancy * Distance from the tumor to the esophagus, stomach, duodenum, small bowel or large bowel \< 0.5 cm on CT or on MRI (randomization imaging). Depending on the SBRT technique used, the minimum acceptable distance may vary and be larger for one technique compared to the other * Uncontrolled portal hypertension (high bleeding risk). If gastroscopy has been performed, untreated esophageal varices grade III or IV.
References
Publications (0)
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