TACE Emulsion Versus Suspension

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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 II 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Cisplatin; Ethiodized Oil

Criteria

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 <= 12cm 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. Child-Pugh B or C cirrhosis

5. History of hepatic encephalopathy

6. Intractable ascites not controllable by medical therapy

7. History of variceal bleeding within last 3 months

8. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)

9. Incorrectable Arterio-portal venous shunt affecting >1 hepatic segment on CT

10. Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT