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Emulsion Versus Suspension in Chemoembolization for Hepatocellular Carcinoma

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Completed

Conditions

Hepatocellular Carcinoma

Treatments

Procedure: Lipiodol-based transarterial chemoembolization

Study type

Interventional

Funder types

Other

Identifiers

NCT03268499
VIR-14-07

Details and patient eligibility

About

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.

Full description

Randomization with 1:1 ratio is centralized and performed by an independent statistician, it is stratified by the diameter of largest tumor less than or equal to 5cm or > 5cm, and total number of tumors less than or equal to 3 or > 3. Random permuted block method with block size of 4 to 6 is used according to a computer-generated allocation sequence. The patients, doctors and other caretakers are not blinded to group allocation. Data collectors and analysts who assess the study outcome and radiologists who assess tumor response are blinded to group allocation.

Assuming the complete response rates in the Suspension Group and Emulsion Group are 70% and 35% respectively, 85% power and 5% level of confidence, the sample size is estimated to be 70 (35 for each arm). Assuming 10 subjects to be withdrawn from the study or lost to follow-up, the final sample size is estimated to be 80.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

Suspension Group
Experimental 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)
Treatment:
Procedure: Lipiodol-based transarterial chemoembolization
Emulsion Group
Active Comparator 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)
Treatment:
Procedure: Lipiodol-based transarterial chemoembolization

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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