Back to resultsSTOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Primary Purpose
Localized Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tandem Microsphere loaded with Epirubicin
Sponsored by
About this trial
This is an interventional treatment trial for Localized Hepatocellular Carcinoma
Eligibility Criteria
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
Sites / Locations
- Beijing Cancer Hospital
- Cancer Hospital Chinese Academy of Medical Sciences
- Guangdong Nanfang Hospital
- Henan Cancer Hospital
- Zhongda Hospital Affiliated Southeast University
- Shengjing Hospital Affiliated China Medical University
- Shanghai Zhongshan Hospital
- Second Aff. Hosp. of Zhejiang University College of Medicine
- The First Affiliated Hospital, Zhejiang University
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single -arm
Arm Description
A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Outcomes
Primary Outcome Measures
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.
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.
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
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.
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.
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.
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.
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
Full Information
NCT ID
NCT03113955
First Posted
March 6, 2017
Last Updated
November 29, 2021
Sponsor
Varian Medical Systems
1. Study Identification
Unique Protocol Identification Number
NCT03113955
Brief Title
STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Official Title
A Single-arm Trial of Transcatheter Arterial Chemoembolization With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Varian Medical Systems
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single -arm
Arm Type
Experimental
Arm Description
A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Intervention Type
Device
Intervention Name(s)
Tandem Microsphere loaded with Epirubicin
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)
Description
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.
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.
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
Secondary Outcome Measure Information:
Title
Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months
Description
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
Title
Number of Participants With Objective Tumor Response at 30-day
Description
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.
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.
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 1month
Title
Kaplan-Meier Analyses the Percent of Participants for PPF(Proportion Progression-Free) at 12 Months
Description
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
Title
Kaplan-Meier Analyses the Percent of Participants for Overall Survival
Description
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
Title
Number of Adverse Events Relate to Study Device in 12 Months Post Procedure
Description
Number and documents of adverse events relate to study device in 12 months post procedure
Time Frame
in 12 months
Title
Number of Participants With Objective Tumor Response at 3 Months
Description
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.
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.
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
Title
Kaplan-Meier Analyses the Percent of Participants for Time to Extrahepatic Spread
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathy Peng
Organizational Affiliation
BSC China
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Guangdong Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Zhongda Hospital Affiliated Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Shengjing Hospital Affiliated China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Second Aff. Hosp. of Zhejiang University College of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
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