STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma

실험적: single -arm

A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma

장치: Tandem Microsphere loaded with Epirubicin

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)

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.

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

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.

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.

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.

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

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.

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