Emulsion Versus Suspension in Chemoembolization for Hepatocellular Carcinoma

NCT03268499 | Completed Results DMC

• 1 other identifier: VIR-14-07
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Number of Paticipants With Complete Tumor Response After the First 3 Treatments

  Complete tumor response is defined according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria as well as DSA findings during the second and third treatment, it is defined as the absence of enhancing tumor on CT and/ or absence of residual tumor on selective DSA of the feeding arteries to the tumors and absence of enhancing tumor on the subsequent CT.

  Within 6 months after randomization

• Number of Participants With Severe Adverse Events of All Treatment Procedures Occurring Within 30 Days of the Treatment

  Severe adverse events is defined as any undesirable symptom, sign or medical condition which was fatal or life-threatening, required or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or was medically significant, might jeopardize the patient and might require medical or surgical intervention.

  within 30 days of the treatment

Secondary Outcomes (10)

• Number of Paticipants With Complete Tumour Response After the First Treatment

  At 3 months after the first treatment

• Number of Participants With Complete or Partial Tumour Response at 6 Months

  At 6 months after the first treatment

• Number of Participants With Intralesional Tumour Progression From Randomization Date up to 78 Months

  throughout follow-up period, up to 78 months

• Number of Participants With Extralesional Tumour Progression From Randomization Date up to 78 Months

  throughout follow-up period, up to 78 months

• Number of Participants With Extrahepatic Tumour Progression up to 78 Months

  throughout follow-up period, up to 78 months

Study Arms (2)

Suspension Group

EXPERIMENTAL

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)

Procedure: Lipiodol-based transarterial chemoembolization

Emulsion Group

ACTIVE COMPARATOR

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)

Procedure: Lipiodol-based transarterial chemoembolization

Interventions

Lipiodol-based transarterial chemoembolization 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.

Also known as: Conventional chemoembolization, cTACE

Emulsion Group; Suspension Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 50% liver volume
• Size of any individual tumor greater than or equal to 10cm in largest dimension
• Serum creatinine \< 130 umol/L or Creatinine clearance \> 55 ml/min.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

Location

Related Publications (1)

• Yu SCH, Chan L, Lee KF, Cho CCM, Hui EP, Chu CCM, Cheung SYS, Lok HT, Li L, Wong JKT, Wong JC, Yuen TY, Yu PSM, Wong SSM, Wong HL, Ho CHCH, Mo F, Yeo WMM. Ethiodized Oil-based Transarterial Chemoembolization for Hepatocellular Carcinoma: Randomized Clinical Trial of Anhydrous Cisplatin Suspension versus Cisplatin Emulsion. Radiology. 2025 Nov;317(2):e242982. doi: 10.1148/radiol.242982.

  PMID: 41288481 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Limitations and Caveats

The number of subjects was relatively small, although the power of study was 85%. Using CT in assessing tumor response in the presence of intratumoral ethiodized oil may suffer a higher risk of missing minute tumors hidden among the ethiodized oil cast and over-diagnosing complete tumor response, however, the study outcomes were unlikely significantly affected, because viable tumors that were missed would have been captured at the study endpoint of intralesional tumor progression.

Results Point of Contact

• Title: Simon Chun Ho Yu
• Organization: The Chinese University of Hong Kong

simonyu@cuhk.edu.hk

+852 35051035

Study Officials

• Simon Yu

  DIIR, CUHK, Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients, doctors and other caretakers are not blinded to group allocation. Data collectors and analysts who assessed the study outcome and radiologists who assessed tumor response are blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: prospective, multi-center, parallel-group, open-label, phase III randomized control trial

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 31, 2017
• Study Start: September 9, 2016
• Primary Completion: February 28, 2023
• Study Completion: April 28, 2023
• Last Updated: November 15, 2024
• Results First Posted: November 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)