N/A
Completed N=80
Emulsion Versus Suspension in Chemoembolization for Hepatocellular Carcinoma
Source: ClinicalTrials.gov NCT03268499 ↗Enrolled (actual)
80
Serious AEs
11.7%
Results posted
Nov 2024
Primary outcomePrimary: Number of Paticipants With Complete Tumor Response After the First 3 Treatments — 35; 18 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Paticipants With Complete Tumor Response After the First 3 Treatments |
35; 18 | — |
| PRIMARY Number of Participants With Severe Adverse Events of All Treatment Procedures Occurring Within 30 Days of the Treatment |
2; 7 | — |
| SECONDARY Number of Paticipants With Complete Tumour Response After the First Treatment |
22; 4 | — |
| SECONDARY Number of Participants With Complete or Partial Tumour Response at 6 Months |
39; 27 | — |
| SECONDARY Number of Participants With Intralesional Tumour Progression From Randomization Date up to 78 Months |
5; 17 | — |
| SECONDARY Number of Participants With Extralesional Tumour Progression From Randomization Date up to 78 Months |
12; 20 | — |
| SECONDARY Number of Participants With Extrahepatic Tumour Progression up to 78 Months |
3; 3 | — |
| SECONDARY Time Interval in Months From Randomization Date to Occurrence of Any Kind of Tumor Progression up to 78 Months |
24.6; 10.7 | — |
| SECONDARY Progression Free Survival in Number of Months up to 78 Months |
21.1; 10.4 | — |
| SECONDARY Overall Survival in Months up to 78 Months |
53.3; 36 | — |
| SECONDARY Adverse Event |
30; 32; 14; 8; 13; 10 | — |
| SECONDARY Serious Adverse Event |
2; 7 | — |
Eligibility Criteria
Inclusion criteria
- Written informed consent
- Age above 18 years
- HCC unsuitable for resection or ablation
- Child-Pugh A cirrhosis
- Eastern Cooperative Oncology Group performance score 0 or 1
- BCLC A or B
- No previous treatment for HCC except for liver resection
- HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.
- No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen.
- No invasion of portal vein or hepatic vein
- 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)
- Total tumor mass 55 ml/min.
Exclusion criteria
- Known active malignancy within the last 3 years
- History of acute tumor rupture presenting with hemo-peritoneum
- Biliary obstruction not amenable to percutaneous or endoscopic drainage
- History of hepatic encephalopathy
- Intractable ascites not controllable by medical therapy
- History of variceal bleeding within last 3 months
- Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
- Un-correctable Arterio-portal venous shunt affecting >1 hepatic segment on CT
- Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
Data sourced from ClinicalTrials.gov (NCT03268499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.