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

Not Applicable

Completed

Conditions: Localized Hepatocellular Carcinoma

Interventions: Device: Tandem Microsphere loaded with Epirubicin

Registration Number: NCT03113955

Lead Sponsor: Varian Medical Systems

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

Detailed Description: It is a prospective, single-arm, multicenter study. The primary effectiveness endpoint for this clinical trial is 6-month overall objective tumor response (ORR).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 109

Inclusion Criteria

Subject is able to provide informed consent and must sign the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent Form.
Male or female of age ≥18 and ≤75 years.
Confirmed diagnosis of HCC according to the diagnostic criteria included in the management guideline issued by China's Ministry of Health in 2017.
HCC is diagnosed for the first time or recurrence of tumor after surgical or ablation treatment.
Single tumor less than 7cm in diameter or multiple tumors with maximum 3 lesions with >1cm in diameter, individual diameter <7cm and less than 10cm in total diameter.
no previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) for HCC
Preserved liver function (Child-Pugh A or B7).
ECOG Performance Status 0 or 1.

Exclusion Criteria

Presence of vascular invasion or extra-hepatic spread of disease, or diffuse HCC, defined as >50% liver involvement , or arteriovenuous fistula
Macrovascular invasion of main or primary branches of portal vein at entry into the study
Any contraindication for TACE treatment
Any contraindication for Epirubicin administration
Advanced liver disease (bilirubin levels >2 mg/dl, AST or ALT >5 times upper limit of normal)
Renal failure or insufficient renal function (Creatinine levels >2 mg/dl)
Subject unable to receive MRI examination
Pregnant or breast feeding woman, or plan to become pregnant during treatment or within 12 months of treatment
couldn't commit reliable birth control measures during treatment or within 12 months of treatment
Subject is participating other investigational drug or device clinical trial within 30 days of signing the informed consent
Subject is not suitable to participate in the study as judged by investigator

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single -arm	Tandem Microsphere loaded with Epirubicin	A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma

Primary Outcome Measures

Name	Time	Method
Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)	At 6 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.

Secondary Outcome Measures

Name	Time	Method
Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months	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	At 1month	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	from first TACE to 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	from first TACE to 12 months	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	in 12 months	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	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	At 12 month	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

Trial Locations

Locations (10): Beijing Cancer Hospital
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Beijing, Beijing, China
Shanghai Zhongshan Hospital
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Shanghai, Shanghai, China
Cancer Hospital Chinese Academy of Medical Sciences
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Beijing, Beijing, China
Second Aff. Hosp. of Zhejiang University College of Medicine
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Hangzhou, Zhejiang, China
Guangdong Nanfang Hospital
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Guangzhou, Guangdong, China
Henan Cancer Hospital
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Zhengzhou, Henan, China
Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University
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Hangzhou, Zhejiang, China
Zhongda Hospital Affiliated Southeast University
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Nanjing, Jiangsu, China
Shengjing Hospital Affiliated China Medical University
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Shenyang, Liaoning, China