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NCT Number: NCT03268499

Emulsion Versus Suspension in Chemoembolization for Hepatocellular Carcinoma

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hong Kong

About this study

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 Assuming 10 subjects to be withdrawn from the study or lost to follow-up, the final sample size is estimated to be 80.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 < 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.

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

Treatment and study plan

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.

Other names: Conventional chemoembolization, cTACE

Primary outcomes

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

    Time frame: Within 6 months after randomization

    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.

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

    Time frame: 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.

Secondary outcomes

  1. Number of Paticipants With Complete Tumour Response After the First Treatment

    Time frame: At 3 months after the first treatment

    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.

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

    Time frame: At 6 months after the first treatment

    Objective tumor response was defined as complete response or partial response. Partial response was defined by the modified RECIST criteria as at least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions

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

    Time frame: throughout follow-up period, up to 78 months

    Intralesional tumor progression is defined as tumor recurrence at the site of treated tumor after initial complete tumor response, or any degree of enlargement of treated tumor after initial partial response;

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

    Time frame: throughout follow-up period, up to 78 months

    Extralesional tumor progression is defined as occurrence of new tumor at a new site of the liver;

  5. Number of Participants With Extrahepatic Tumour Progression up to 78 Months

    Time frame: throughout follow-up period, up to 78 months

    Extrahepatic tumor progression is defined as occurrence of venous invasion by tumor or extrahepatic tumor metastasis;

  6. Time Interval in Months From Randomization Date to Occurrence of Any Kind of Tumor Progression up to 78 Months

    Time frame: throughout follow-up period, up to 78 months

    Any kind of tumor progression include intralesional progression, extralesional progression, or extrahepatic progression

  7. Progression Free Survival in Number of Months up to 78 Months

    Time frame: throughout follow-up period, up to 78 months

    Progression free survival is defined as the interval between the randomization date and the date of any kind of tumor progression or death from any cause;

  8. Overall Survival in Months up to 78 Months

    Time frame: throughout follow-up period, up to 78 months

    Overall survival Overall survival is defined as the interval between the randomization date and the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive;

  9. Adverse Event

    Time frame: Within 30 days after the first treatment

    Number of participants with the specific adverse event that occurred within 30 days after the first treatment

  10. Serious Adverse Event

    Time frame: Within 30 days after all treatments

    Serious adverse event that occurs within 30 days after all treatments

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Ethiodized Oil-based Transarterial Chemoembolization for Patients With Hepatocellular Carcinoma: A Randomized Controlled Trial of Aqueous Cisplatin Emulsion Versus Anhydrous Cisplatin Suspension

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2017
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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