A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
It is a prospective, single-arm, multicenter study. The primary effectiveness endpoint for this clinical trial is 6-month overall objective tumor response (ORR).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
109
The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Guangdong Nanfang Hospital
Guangzhou, Guangdong, China
Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)
The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR. 1. Per Response Evaluation Criteria In Solid Tumors Criteria (mRECIST ) for target lesions : Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. 2. Per Response Evaluation Criteria In Solid Tumors Criteria (EASL) for target lesions: Complete Response (CR), Disappearance of all known disease and no new lesions determined by two observations not less than 4 weeks apart; Partial Response (PR), At least 50% reduction in total tumor load of all measurable lesions determined by two observations not less than 4 weeks apart.
Time frame: At 6 months
Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months
Kaplan-Meier analyses the percent of participants for TTP which is defined as the length of time from the treatment initiation to either the date of the first disease progression occurred, as assessed by the investigators, or the date of the subject died due to any cause, whichever comes earlier. EASL and mRECIST response assessment of target lesion for HCC. TTP (also referred as "time to treatment failure") will be measured by a few data items list below: * The date of the disease progression in the Overall Response form * The date of lost-to-follow due to: * Adverse events * Progressive disease/insufficient therapeutic response * Death * Failure to return * Refusing treatment/being unwilling to cooperate/withdrawing consent * The very last date by scanning all available dates in the database * The desired cut-off days
Time frame: At 12 months
Number of Participants With Objective Tumor Response at 30-day
The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR. 1. Per Response Evaluation Criteria In Solid Tumors Criteria (mRECIST ) for target lesions : Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. 2. Per Response Evaluation Criteria In Solid Tumors Criteria (EASL) for target lesions: Complete Response (CR), Disappearance of all known disease and no new lesions determined by two observations not less than 4 weeks apart; Partial Response (PR), At least 50% reduction in total tumor load of all measurable lesions determined by two observations not less than 4 weeks apart.
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Henan Cancer Hospital
Zhengzhou, Henan, China
Zhongda Hospital Affiliated Southeast University
Nanjing, Jiangsu, China
Shengjing Hospital Affiliated China Medical University
Shenyang, Liaoning, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Second Aff. Hosp. of Zhejiang University College of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Time frame: At 1month
Kaplan-Meier Analyses the Percent of Participants for PPF(Proportion Progression-Free) at 12 Months
Kaplan-Meier analyses the percent of participants for PPF which is defined as the length of time from the treatment initiation, that treated subjects are still progression-free. EASL and mRECIST response assessment of target lesion for HCC. The data items to be captured will include: * The date of the disease progression in the Overall Response form * The very last date by scanning all available dates in the database * The desired cut-off days The proportion of any time point will be determined by the Kaplan-Meier estimates.
Time frame: from first TACE to 12 months
Kaplan-Meier Analyses the Percent of Participants for Overall Survival
Kaplan-Meier analyses the percent of participants for Overall survival which is defined as the length of time from the treatment initiation, that treated subjects are still alive. The Kaplan-Meier analysis is aimed to capture the all-cause death for each subject. Subjects who are lost-to-follow will be considered being censored. There are three critical data items to be captured: * Death date * The very last date in the database (e.g. follow-up visit date and/or site reported AE date) * The desired cut-off days (e.g. 6-month OS at 182 days, 12-month OS at 365 days) In addition to the Kaplan-Meier survival curve, the median survival time (mOS) will also be used to represent the study cohort.
Time frame: from first TACE to 12 months
Number of Adverse Events Relate to Study Device in 12 Months Post Procedure
Number and documents of adverse events relate to study device in 12 months post procedure
Time frame: in 12 months
Number of Participants With Objective Tumor Response at 3 Months
The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR. 1. Per Response Evaluation Criteria In Solid Tumors Criteria (mRECIST ) for target lesions : Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. 2. Per Response Evaluation Criteria In Solid Tumors Criteria (EASL) for target lesions: Complete Response (CR), Disappearance of all known disease and no new lesions determined by two observations not less than 4 weeks apart; Partial Response (PR), At least 50% reduction in total tumor load of all measurable lesions determined by two observations not less than 4 weeks apart.
Time frame: At 3 months
Kaplan-Meier Analyses the Percent of Participants for Time to Extrahepatic Spread
Kaplan-Meier analyses the percent of participants for Time to Extrahepatic Spread which the length of time from the treatment initiation to the development of extrahepatic spread of the disease via imaging assessment. The data items to be considered will include: * The date of the extrahepatic spread in the Overall Response form * The very last date by scanning all available dates in the database * The desired cut-off days
Time frame: At 12 month