Clinical trial · Observational
Prospective Study to Evaluate Safety of Deb-TACE With 100µ Beads in Patients With Non Resectable HCC
Prospective, Multicenter, Non Randomized, Single Arm Study to Evaluate Safety of Transarterial Chemoembolization (TACE) With Doxorubicin Eluting 100 µ Microspheres in Patients With Non Resectable Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an observational, multicenter, single arm, prospective study to evaluate safety and tolerability of selective and ultraselective drug eluting beads transcatheter intraarterial chemoembolization (DEB-TACE) with up to 3 ml of well calibrated 100 µ microspheres and up to 150 mg of doxorubicin, for the treatment of non resectable hepatocellular carcinoma (HCC). The hypothesis is that 100 µ beads penetrate deeper into the tumor than those eluting beads with larger volumes without increasing the risk and complications of DEB-TACE.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEB-TACE | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with non resectable HCC
- description
- DEB-TACE with doxorubicin eluting 100 µ microspheres
- interventionNames
- Device: DEB-TACE
Primary outcomes (1)
- measure
- Safety and Tolerability
- timeFrame
- 30 days
- description
- Major and minor complications, procedure related mortality and post-embolisation syndrome after DEB-TACE of non-resectable HCC, using 100-µm doxorubicin-loaded microspheres
Secondary outcomes (2)
- measure
- Tumor Response
- timeFrame
- 6 months, 1 year, 2 year
- description
- Devascularization pattern in the treated tumor, assessed with the modified RECIST (mRECIST), in the contrast enhanced liver CT or MR obtained during FU.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a diagnosis of HCC according to European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD) criteria and staged by BCLC criteria 2. Indication for receiving transarterial chemoembolization DEB-TACE with 100 µ microspheres according to usual clinical practice. 3. Able and willing to participate and give their written informed consent. 4. Both genders and ≥ 18 years old. 5. Eastern Cooperative Oncology Group (ECOG) 0 6. Preserved hepatic function (Child-Pugh ≤ B7). 7. No evidence of tumoral invasion in portal vein or main biliary ducts. 8. Able to go through image diagnostic techniques such as CT or MRI. 9. Preserved cardiac and renal function. 10. No concomitant active infections that require antibiotic treatment. 11. Measurable disease according to mRECIST criteria. 12. Life expectancy over 6 months. Exclusion Criteria: 1. ECOG ≥ 1 2. Child-Pugh ≥B8. 3. Presence of ascitis or encephalopathy 4. Extrahepatic tumoral disease. 5. Tumoral vascular invasion 6. Serum bilirubin\>3 mg/dl. 7. Cr Clearance ≤ 60 ml/min 8. If any of the following is contraindicated: 1. Administration of doxorubicin 2. Iodated contrasts 3. CT or MRI procedures 4. Transarterial embolization procedures 5. White blood cells (WBC) \< 2000 /mm3 6. Neutrophil count \< 1500 /mm3 7. Ejection fraction \< 50 % 8. Platelet count \< 5 x 104/mm3, international normalized ratio (INR) \> 2,0) 9. Transaminases (AST and/or ALT) \> 5x upper limit of normal or \>250 u/l 10. Known hepatofugal portal vein flow 11. A-V intrahepatic macroscopic fistula 9. Pregnant or breast feeding women. 10. Tumor burden involving more than 50% of the liver. 11. Active bacterial or fungal infection. 12. Other concomitant tumors. 13. Any other condition that according to investigator criteria, contraindicates DEB-TACE. 14. Patients not willing to participate and/or give their written informed consent.
References
Publications (1)
- DERIVEDUrbano J, Echevarria-Uraga JJ, Ciampi-Dopazo JJ, Sanchez-Corral JA, Cobos Alonso J, Anton-Ladislao A, Pena-Baranda B, Nacarino-Mejias V, Gonzalez-Costero R, Munoz Ruiz-Canela JJ, Perez-Cuesta J, Lanciego C, de Gregorio MA. Multicentre prospective study of drug-eluting bead chemoembolisation safety using tightly calibrated small microspheres in non-resectable hepatocellular carcinoma. Eur J Radiol. 2020 May;126:108966. doi: 10.1016/j.ejrad.2020.108966. Epub 2020 Mar 19. PMID 32278280