Clinical trial · Interventional
Emulsion Versus Suspension in Chemoembolization for Hepatocellular Carcinoma
Ethiodized Oil-based Transarterial Chemoembolization for Patients With Hepatocellular Carcinoma: A Randomized Controlled Trial of Aqueous Cisplatin Emulsion Versus Anhydrous Cisplatin Suspension
- 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 the study was to evaluate the safety and efficacy of using the new formulation (Lipiodol-cisplatin suspension) for TACE in the treatment of HCC as compared to the conventional formulation (Lipiodol-cisplatin emulsion). This is a prospective, parallel-group, open-label randomized, phase III study that is conducted in accordance to the Declaration of Helsinki and international standards of Good Clinical Practice, and approved by the institutional review board. Eligible patients were randomized into either a treatment arm of Lipiodol-cisplatin suspension or a control arm of Lipiodol-cisplatin emulsion with a 1:1 ratio.
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 |
|---|---|---|---|
| Lipiodol-based transarterial chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Suspension Group
- description
- Patients are treated with chemoembolization using a formulation that consists of a suspension of 100mg pure anhydrous cisplatin in 20mL Lipiodol (5mg cisplatin /mL suspension)
- interventionNames
- Procedure: Lipiodol-based transarterial chemoembolization
- type
- ACTIVE_COMPARATOR
- label
- Emulsion Group
- description
- Patients are treated with chemoembolization using a formulation that consists of 10mg aqueous cisplatin (10mL) mixed with 10mL Lipiodol to form an emulsion (0.5mg cisplatin/mL emulsion)
- interventionNames
- Procedure: Lipiodol-based transarterial chemoembolization
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria 1. Written informed consent 2. Age above 18 years 3. HCC unsuitable for resection or ablation 4. Child-Pugh A cirrhosis 5. Eastern Cooperative Oncology Group performance score 0 or 1 6. BCLC A or B 7. No previous treatment for HCC except for liver resection 8. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology. 9. No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen. 10. No invasion of portal vein or hepatic vein 11. Massive expansive tumor morphology with measurable lesion on CT (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions) 12. Total tumor mass \< 50% liver volume 13. Size of any individual tumor greater than or equal to 10cm in largest dimension 14. Serum creatinine \< 130 umol/L or Creatinine clearance \> 55 ml/min. Exclusion criteria 1. Known active malignancy within the last 3 years 2. History of acute tumor rupture presenting with hemo-peritoneum 3. Biliary obstruction not amenable to percutaneous or endoscopic drainage 4. History of hepatic encephalopathy 5. Intractable ascites not controllable by medical therapy 6. History of variceal bleeding within last 3 months 7. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules) 8. Un-correctable Arterio-portal venous shunt affecting \>1 hepatic segment on CT 9. Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
References
Publications (1)
- DERIVEDYu SCH, Chan L, Lee KF, Cho CCM, Hui EP, Chu CCM, Cheung SYS, Lok HT, Li L, Wong JKT, Wong JC, Yuen TY, Yu PSM, Wong SSM, Wong HL, Ho CHCH, Mo F, Yeo WMM. Ethiodized Oil-based Transarterial Chemoembolization for Hepatocellular Carcinoma: Randomized Clinical Trial of Anhydrous Cisplatin Suspension versus Cisplatin Emulsion. Radiology. 2025 Nov;317(2):e242982. doi: 10.1148/radiol.242982. PMID 41288481