Ethiodized Oil-based Transarterial Chemoembolization for Patients With Hepatocellular Carcinoma: A Randomized Controlled Trial of Aqueous Cisplatin Emulsion Versus Anhydrous Cisplatin Suspension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of Paticipants With Complete Tumor Response After the First 3 Treatments
研究概览
简要总结
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.
详细描述
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 Assuming 10 subjects to be withdrawn from the study or lost to follow-up, the final sample size is estimated to be 80.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Paticipants With Complete Tumor Response After the First 3 Treatments
时间窗: 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
时间窗: 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.
次要结局
- Number of Paticipants With Complete Tumour Response After the First Treatment(At 3 months after the first treatment)
- 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)
- 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)
- Serious Adverse Event(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)
- Overall Survival in Months up to 78 Months(throughout follow-up period, up to 78 months)
- Adverse Event(Within 30 days after the first treatment)
研究者
Simon Yu
Professor
Chinese University of Hong Kong