Hepatocellular CarcinomaNCT03268499
Emulsion Versus Suspension in Chemoembolization for Hepatocellular Carcinoma
A study testing Lipiodol-based transarterial chemoembolization in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Lipiodol-based transarterial chemoembolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Sep 2016to 28 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
About this study
Official title: Ethiodized Oil-based Transarterial Chemoembolization for Patients With Hepatocellular Carcinoma: A Randomized Controlled Trial of Aqueous Cisplatin Emulsion Versus Anhydrous Cisplatin Suspension
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.
Read the 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
- Being tested
- Lipiodol-based transarterial chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipiodol-based transarterial chemoembolizationProcedure or surgery
Also called Conventional chemoembolization, cTACE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: Lipiodol-based transarterial chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: within 30 days of the treatment
Secondary outcomes (10)
Number of Paticipants With Complete Tumour Response 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.
Measured: At 3 months after the first treatment
Number of Participants With Complete or Partial Tumour Response at 6 Months
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
Measured: At 6 months after the first treatment
Number of Participants With Intralesional Tumour Progression From Randomization Date 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;
Measured: throughout follow-up period, up to 78 months
Number of Participants With Extralesional Tumour Progression From Randomization Date up to 78 Months
Extralesional tumor progression is defined as occurrence of new tumor at a new site of the liver;
Measured: throughout follow-up period, up to 78 months
Number of Participants With Extrahepatic Tumour Progression up to 78 Months
Extrahepatic tumor progression is defined as occurrence of venous invasion by tumor or extrahepatic tumor metastasis;
Measured: throughout follow-up period, up to 78 months
Time Interval in Months From Randomization Date to Occurrence of Any Kind of Tumor Progression up to 78 Months
Any kind of tumor progression include intralesional progression, extralesional progression, or extrahepatic progression
Measured: throughout follow-up period, up to 78 months
Progression Free Survival in Number of Months 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;
Measured: throughout follow-up period, up to 78 months
Overall Survival in Months 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;
Measured: throughout follow-up period, up to 78 months
Adverse Event
Number of participants with the specific adverse event that occurred within 30 days after the first treatment
Measured: Within 30 days after the first treatment
Serious Adverse Event
Serious adverse event that occurs within 30 days after all treatments
Measured: Within 30 days after all treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start9 Sep 2016
- Primary completion28 Feb 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, multi-center, parallel-group, open-label, phase III randomized control trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Yu, Chinese University of Hong Kong
- Investigators
- Simon Yu, Principal investigator, DIIR, CUHK, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268499
- Sponsor's protocol ID
- VIR-14-07
- Status last verified
- Mar 2024
- First submitted
- 29 Aug 2017
- Last updated
- 15 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41288481
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethiodized Oil-based Transarterial Chemoembolization for Patients With Hepatocellular Carcinoma: A Randomized Controlled Trial of Aqueous Cisplatin Emulsion Versus Anhydrous Cisplatin Suspension
- ClinicalTrials.gov ID
- NCT03268499
- Acronym / sponsor ID
- VIR-14-07
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 9 Sep 2016 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Posted 15 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, multi-center, parallel-group, open-label, phase III randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Suspension Group | Experimental | Procedure: Lipiodol-based transarterial chemoembolizationPatients are treated with chemoembolization using a formulation that consists of a suspension of 100mg pure anhydrous cisplatin in 20mL Lipiodol (5mg cisplatin /mL suspension) |
| Emulsion Group | Active comparator | Procedure: Lipiodol-based transarterial chemoembolizationPatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipiodol-based transarterial chemoembolizationAlso: Conventional chemoembolization, cTACEArterial 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. | Procedure or surgery | Emulsion Group, Suspension Group |
Primary outcome
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.
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.
10 secondary outcomes
Number of Paticipants With Complete Tumour Response After the First Treatment
Time frame: At 3 months after the first treatment
Number of Participants With Complete or Partial Tumour Response at 6 Months
Time frame: At 6 months after the first treatment
Number of Participants With Intralesional Tumour Progression From Randomization Date up to 78 Months
Time frame: throughout follow-up period, up to 78 months
Number of Participants With Extralesional Tumour Progression From Randomization Date up to 78 Months
Time frame: throughout follow-up period, up to 78 months
Number of Participants With Extrahepatic Tumour Progression up to 78 Months
Time frame: throughout follow-up period, up to 78 months
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
Progression Free Survival in Number of Months up to 78 Months
Time frame: throughout follow-up period, up to 78 months
Overall Survival in Months up to 78 Months
Time frame: throughout follow-up period, up to 78 months
Adverse Event
Time frame: Within 30 days after the first treatment
Serious Adverse Event
Time frame: Within 30 days after all treatments
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41288481Yu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Yu principal investigator
DIIR, CUHK, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipiodol-based transarterial chemoembolization in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Paticipants With Complete Tumor Response After the First 3 Treatments (time frame: Within 6 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03268499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.