Clinical trial · Interventional
Transarterial Radioembolization Versus Chemoembolization for the Treatment of Hepatocellular Carcinoma
Transarterial Radioembolization Versus Chemoembolization for the Treatment of Advanced 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)
Hepatocellular Carcinoma (HCC) is a primary liver cancer. It is the 6th most common malignancy and the 3rd killers of all tumors worldwide with an incidence of 626,000 new patients a year. The intermediate stage of HCC is controlled by radiological interventions such as Transarterial Chemoembolization (TACE) or Radioembolization. Although 90Y radioembolization is increasingly being used in clinical practice, there is no high quality clinical evidence to justify this. To date, no prospective studies have been performed comparing both treatment modalities (TACE vs 90Y) in a randomized setting. This randomized controlled trial is designed to prospectively compare TACE and 90Y for treatment of patients with unresectable (BCLC intermediate stage) HCC. This will be done by recruiting 75 patients in each arm from. Investigators will compare between the two groups the time to progression (TTP) as the primary outcome and also examine time to local progression (TLP) as well as other factors like overall survival, response to therapy, toxicities and adverse events, quality of life and treatment-related costs.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transarterial Chemoembolization using drug-eluting beads | Procedure | — | UNRESOLVED |
| Transarterial Radioembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Intervention: Yttrium-90 Transarterial Radioembolization * Patients with measurable, locally advanced HCC those are not suitable to have or have failed potentially curable intervention (Radio frequency ablation for small tumor, resection or transplantation). * The diagnosis of HCC should be established either by cyto/histology; or, by characteristic imaging studies in patients with cirrhosis of the liver and/or chronic viral hepatitis B or C infection. * Patients must not be less than 18 and not more than 80 and can be either gender. * Patients must have a performance status of ECOG score equal to or less than 2. * Child-Pugh's A or Early B, score 8 and above
- interventionNames
- Procedure: Transarterial Radioembolization
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Intervention: Trans-arterial chemo-embolization using Drug-eluting beads * Patients with measurable, locally advanced HCC those are not suitable to have or have failed potentially curable intervention (Radio frequency ablation for small tumor, resection or transplantation). * The diagnosis of HCC should be established either by cyto/histology; or, by characteristic imaging studies in patients with cirrhosis of the liver and/or chronic viral hepatitis B or C infection. * Patients must not be less than 18 and not more than 80 and can be either gender. * Patients must have a performance status of ECOG score equal to or less than 2. * Child-Pugh's A or Early B, score 8 and above
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with measurable, locally advanced HCC those are not suitable to have or have failed potentially curable intervention (Radio frequency ablation for small tumor, resection or transplantation). * The diagnosis of HCC should be established either by cyto/histology; or, by characteristic imaging studies in patients with cirrhosis of the liver and/or chronic viral hepatitis B or C infection. * Patients must not be less than 18 and not more than 80 and can be either gender. * Patients must have a performance status of ECOG score equal to or less than 2. * Child-Pugh's A or Early B, score 8 and above (see table) * Patients must have adequate organ function as evidenced by: Absolute neutrophil count (ANC) ≥1.5 x 109/L Platelet count ≥50 x 109/L Hg \>9 g/d. AST or ALT ≤5 x ULN Serum creatinine ≤2 x ULN OR creatinine clearance ≥50 mL/min (estimated by Cockcroft Gault or measured) Normal mg and K Bleeding diathesis or on Vit. K therapy. * Patients must fulfill Child-Pugh's Score * Life expectancy equal to or more than 12 weeks. * Signed informed consent. * Sexually active patients, in conjunction with their partner, must practice birth control during, and for 2 months after therapy. * Female patients at child-bearing age must have negative pregnancy test. * No known HIV infection. Exclusion Criteria: * Patients with metastases outside the liver. * Patients with co-morbid condition that will be aggravated by the investigational drug or by the intervention. * Patients with severe cardiopulmonary diseases (including history of stable, effort-induced or unstable angina pectoris or myocardiac infarction) and other systemic diseases under poor control. * Patients with active infection. * Patients with history of psychiatric disorder. * Patients with concomitant active secondary malignancies, except for surgically cured carcinoma in situ of the cervix and basal or adequately treated squamous cell carcinoma of the skin. Disease-free of malignancies \< 2 years before the study, are not eligible. * Clinically significant third space fluid accumulation (i.e., ascites requiring paracentesis despite use of diuretics) or pleural effusion that either requires thoracocentesis or is associated with shortness of breath * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection. * Concurrent usage of hormonal or chemotherapeutic agents. * Patients who received surgery, radiotherapy except to bone, chemotherapy, immunotherapy, or other investigational drug within 4 weeks before initiating study are not eligible. * Patients who are pregnant, breast-feeding or not using appropriate birth control during the course of the study. * Patients with partner of child bearing age who are not willing to use appropriate contraceptives during and 8 week after therapy. * Non compliance. * Unwilling to disclose medical information.
References
Publications (33)
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- RESULTEl-Serag HB. Hepatocellular carcinoma: recent trends in the United States. Gastroenterology. 2004 Nov;127(5 Suppl 1):S27-34. doi: 10.1053/j.gastro.2004.09.013. PMID 15508094
- RESULTLiapi E, Geschwind JF. Transcatheter and ablative therapeutic approaches for solid malignancies. J Clin Oncol. 2007 Mar 10;25(8):978-86. doi: 10.1200/JCO.2006.09.8657. PMID 17350947
- RESULTLlovet JM, Fuster J, Bruix J; Barcelona-Clinic Liver Cancer Group. The Barcelona approach: diagnosis, staging, and treatment of hepatocellular carcinoma. Liver Transpl. 2004 Feb;10(2 Suppl 1):S115-20. doi: 10.1002/lt.20034. PMID 14762851
- RESULTBruix J, Llovet JM. Major achievements in hepatocellular carcinoma. Lancet. 2009 Feb 21;373(9664):614-6. doi: 10.1016/S0140-6736(09)60381-0. No abstract available. PMID 19231618
- RESULTBREEDIS C, YOUNG G. The blood supply of neoplasms in the liver. Am J Pathol. 1954 Sep-Oct;30(5):969-77. No abstract available. PMID 13197542
- RESULTLiapi E, Georgiades CC, Hong K, Geschwind JF. Transcatheter arterial chemoembolization: current technique and future promise. Tech Vasc Interv Radiol. 2007 Mar;10(1):2-11. doi: 10.1053/j.tvir.2007.08.008. PMID 17980314
- RESULTBuijs M, Vossen JA, Frangakis C, Hong K, Georgiades CS, Chen Y, Liapi E, Geschwind JF. Nonresectable hepatocellular carcinoma: long-term toxicity in patients treated with transarterial chemoembolization--single-center experience. Radiology. 2008 Oct;249(1):346-54. doi: 10.1148/radiol.2483071902.