- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03113955
STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
A Single-arm Trial of Transcatheter Arterial Chemoembolization With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China
- Beijing Cancer Hospital
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Beijing, Beijing, China
- Cancer Hospital Chinese Academy of Medical Sciences
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Guangdong
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Guangzhou, Guangdong, China
- Guangdong Nanfang Hospital
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Henan
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Zhengzhou, Henan, China
- Henan Cancer Hospital
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Jiangsu
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Nanjing, Jiangsu, China
- Zhongda Hospital Affiliated Southeast University
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Liaoning
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Shenyang, Liaoning, China
- Shengjing Hospital Affiliated China Medical University
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Shanghai
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Shanghai, Shanghai, China
- Shanghai Zhongshan Hospital
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Zhejiang
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Hangzhou, Zhejiang, China
- Zhejiang Cancer hospital
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Hangzhou, Zhejiang, China
- The First Affiliated Hospital, Zhejiang University
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Hangzhou, Zhejiang, China
- Second Aff. Hosp. of Zhejiang University College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single -arm
A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)
Time Frame: At 6 months
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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.
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At 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months
Time Frame: At 12 months
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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:
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At 12 months
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Number of Participants With Objective Tumor Response at 30-day
Time Frame: At 1month
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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.
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At 1month
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Kaplan-Meier Analyses the Percent of Participants for PPF(Proportion Progression-Free) at 12 Months
Time Frame: from first TACE to 12 months
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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:
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from first TACE to 12 months
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Kaplan-Meier Analyses the Percent of Participants for Overall Survival
Time Frame: from first TACE to 12 months
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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:
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from first TACE to 12 months
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Number of Adverse Events Relate to Study Device in 12 Months Post Procedure
Time Frame: in 12 months
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Number and documents of adverse events relate to study device in 12 months post procedure
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in 12 months
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Number of Participants With Objective Tumor Response at 3 Months
Time Frame: At 3 months
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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.
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At 3 months
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Kaplan-Meier Analyses the Percent of Participants for Time to Extrahepatic Spread
Time Frame: At 12 month
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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:
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At 12 month
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Cathy Peng, BSC China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Epirubicin
Other Study ID Numbers
- S2382
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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