Emulsion Versus Suspension in Chemoembolization for Hepatocellular Carcinoma
- Registration Number
- NCT03268499
- Lead Sponsor
- Chinese University of Hong Kong
- 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 Assuming 10 subjects to be withdrawn from the study or lost to follow-up, the final sample size is estimated to be 80.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lipiodol-cisplatin suspension Cisplatin - Lipiodol-cisplatin emulsion Cisplatin -
- Primary Outcome Measures
Name Time Method Number of Paticipants With Complete Tumor Response After the First 3 Treatments 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 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 Outcome Measures
Name Time Method Number of Paticipants With Complete Tumour Response After the First Treatment 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.
Time Interval in Months From Randomization Date to Occurrence of Any Kind of Tumor Progression up to 78 Months throughout follow-up period, up to 78 months Any kind of tumor progression include intralesional progression, extralesional progression, or extrahepatic progression
Number of Participants With Complete or Partial Tumour Response at 6 Months 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
Number of Participants With Intralesional Tumour Progression From Randomization Date up to 78 Months 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;
Number of Participants With Extralesional Tumour Progression From Randomization Date up to 78 Months 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;
Number of Participants With Extrahepatic Tumour Progression up to 78 Months throughout follow-up period, up to 78 months Extrahepatic tumor progression is defined as occurrence of venous invasion by tumor or extrahepatic tumor metastasis;
Serious Adverse Event Within 30 days after all treatments Serious adverse event that occurs within 30 days after all treatments
Progression Free Survival in Number of Months up to 78 Months 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;
Overall Survival in Months up to 78 Months 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;
Adverse Event Within 30 days after the first treatment Number of participants with the specific adverse event that occurred within 30 days after the first treatment
Trial Locations
- Locations (1)
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
ðŸ‡ðŸ‡°Hong Kong, Hong Kong