Clinical trial · Interventional
Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma
NCT03662841CI-TRIAL-00066132terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor patient accrual
Summary
Brief summary (as posted)
The objective of this study is to study the safety and tumor response of ACE for large HCC.
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ablative chemoembolization (ACE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ACE for HCC of size >10cm
- description
- Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin
- interventionNames
- Procedure: Ablative chemoembolization (ACE)
Primary outcomes (1)
- measure
- Time to progression
- timeFrame
- 3 to 6 months after treatment
- description
- the interval between the first treatment date and the date of radiological progression, including intralesional progression, extralesional progression, or extra-hepatic progression
Secondary outcomes (1)
- measure
- Tumor response
- timeFrame
- 3 to 6 months after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signage of a written informed consent 2. Age above 18 years 3. HCC unsuitable for resection 4. Child-Pugh A or B cirrhosis 5. Eastern Cooperative Oncology Group performance score 0 or 1 6. No previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy), 7. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology. 8. No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen. 9. No invasion of portal vein or hepatic vein 10. 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) 11. Total tumor mass \< 50% liver volume 12. Size of any individual tumor \>10cm in largest dimension Exclusion Criteria: 1. History of acute tumor rupture presenting with hemo-peritoneum 2. Biliary obstruction not amenable to percutaneous or endoscopic drainage 3. Child-Pugh C cirrhosis 4. History of hepatic encephalopathy 5. Intractable ascites not controllable by medical therapy 6. History of variceal bleeding within last 3 months 7. Serum total bilirubin level \> 50 umol/L 8. Serum albumin level \< 25g/L 9. INR \> 1.7 10. Serum creatinine level \> 150 mmol/L. 11. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules) 12. Arterio-portal venous shunt affecting \>1 hepatic segment on CT 13. Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
References
Publications (0)
Data not yet available
No reference posted for this study.