Emulsion Versus Suspension in Chemoembolization for Hepatocellular Carcinoma

NCT ID: NCT03268499

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-09
• Study Completion Date: 2023-04-28

Brief 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.

Detailed 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 Assuming 10 subjects to be withdrawn from the study or lost to follow-up, the final sample size is estimated to be 80.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Suspension Group

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)

Group Type: EXPERIMENTAL

Lipiodol-based transarterial chemoembolization

Intervention Type: PROCEDURE

Arterial catheterization to segmental, subsegmental, or sub-subsegmental level was achieved depending on the tumor size, to gain arterial access as close to the tumors as possible. The formulation was delivered under fluoroscopic control until the vasculature of all tumors was entirely filled, or until the maximum dose was reached.

Emulsion Group

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)

Group Type: ACTIVE_COMPARATOR

Lipiodol-based transarterial chemoembolization

Intervention Type: PROCEDURE

Arterial catheterization to segmental, subsegmental, or sub-subsegmental level was achieved depending on the tumor size, to gain arterial access as close to the tumors as possible. The formulation was delivered under fluoroscopic control until the vasculature of all tumors was entirely filled, or until the maximum dose was reached.

Interventions

Lipiodol-based transarterial chemoembolization

Arterial catheterization to segmental, subsegmental, or sub-subsegmental level was achieved depending on the tumor size, to gain arterial access as close to the tumors as possible. The formulation was delivered under fluoroscopic control until the vasculature of all tumors was entirely filled, or until the maximum dose was reached.

Intervention Type: PROCEDURE

Other Intervention Names

Conventional chemoembolization; cTACE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Simon Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon Yu

Role: PRINCIPAL_INVESTIGATOR

DIIR, CUHK, Hong Kong

Locations

Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

VIR-14-07

Identifier Type: -

Identifier Source: org_study_id