Clinical trial · Interventional
Effectiveness of Drug Eluting TACE in Primary HCC
Effectiveness of Drug Eluting & Conventional Trans-arterial Chemo-embolization in Treatment of Primary Hepatic Cell Carcinoma
NCT04048317CI-TRIAL-00039950unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
the aim of this work to compare effectiveness of drug-eluting bead trans-arterial chemo-embolization and conventional trans-arterial chemo-embolization of hepatic cell carcinoma in the aspect of (Tumor response via m-RECIST criteria), (liver injury via Liver function tests and tumor markers) and (survival outcome) of patients treated in Assiut university .
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 |
|---|---|---|---|
| Hepatic Cell Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HepaSphere Microspheres/Doxorubicin Hydrochloride | Drug | — | UNRESOLVED |
| Lipiodol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- drug eluting bead trans arterial chemo embolization
- description
- the international arm is the patients embolized with drug eluting bead trans arterial chemo embolization using Hepasphere
- interventionNames
- Drug: HepaSphere Microspheres/Doxorubicin Hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- conventional trans arterial chemo embolization
- description
- the control arm is the patients embolized with drug eluting bead trans arterial chemo embolization using Lipiodol
- interventionNames
- Drug: Lipiodol
Primary outcomes (1)
- measure
- Evaluate the effectiveness of drug-eluting bead trans-arterial chemo-embolization in patients of hepatocellular carcinoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * patients must be 18 to 75 years old. * patients must be diagnosed as primary Hepatocellular carcinoma (HCC) by radiologic imaging revealed angiogenicity pattern . * All of the patient have Child-Pugh status A or B . * All of the patient have BCLC stage A or B. * patients must have adequate renal and liver function accepting the maneuver. * patients must have adequate coagulation profile (platelets count ≥ 80 000), (prothrombin concentration ≥ 70 %). * patients must haven't previous history of resection of other ablation (alcohol, radio frequency or micro wave ablation). Exclusion Criteria: * patients have previous history of resection of other ablation (alcohol, radio frequency or micro wave ablation). * patients with impaired coagulation profile (platelets count \< 80 000), (prothrombin concentration \< 70 %). * patients with decompensated liver cell failure having ascites which impedes the maneuver . * patients with past history of reaction to the drug used in maneuver * patients with poor image quality. * patients with lost follow up .
References
Publications (10)
- BACKGROUNDFerlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9. PMID 25220842
- BACKGROUNDKudo M, Izumi N, Kokudo N, Matsui O, Sakamoto M, Nakashima O, Kojiro M, Makuuchi M; HCC Expert Panel of Japan Society of Hepatology. Management of hepatocellular carcinoma in Japan: Consensus-Based Clinical Practice Guidelines proposed by the Japan Society of Hepatology (JSH) 2010 updated version. Dig Dis. 2011;29(3):339-64. doi: 10.1159/000327577. Epub 2011 Aug 9. PMID 21829027
- BACKGROUNDZhang BH, Yang BH, Tang ZY. Randomized controlled trial of screening for hepatocellular carcinoma. J Cancer Res Clin Oncol. 2004 Jul;130(7):417-22. doi: 10.1007/s00432-004-0552-0. PMID 15042359
- BACKGROUNDYang HJ, Lee JH, Lee DH, Yu SJ, Kim YJ, Yoon JH, Kim HC, Lee JM, Chung JW, Yi NJ, Lee KW, Suh KS, Lee HS. Small single-nodule hepatocellular carcinoma: comparison of transarterial chemoembolization, radiofrequency ablation, and hepatic resection by using inverse probability weighting. Radiology. 2014 Jun;271(3):909-18. doi: 10.1148/radiol.13131760. Epub 2014 Feb 8. PMID 24520944
- BACKGROUNDSalem R, Lewandowski RJ. Chemoembolization and radioembolization for hepatocellular carcinoma. Clin Gastroenterol Hepatol. 2013 Jun;11(6):604-11; quiz e43-4. doi: 10.1016/j.cgh.2012.12.039. Epub 2013 Jan 26. PMID 23357493
- BACKGROUNDHsu CY, Huang YH, Chiou YY, Su CW, Lin HC, Lee RC, Chiang JH, Huo TI, Lee FY, Lee SD. Comparison of radiofrequency ablation and transarterial chemoembolization for hepatocellular carcinoma within the Milan criteria: a propensity score analysis. Liver Transpl. 2011 May;17(5):556-66. doi: 10.1002/lt.22273. PMID 21506244