STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
NCT ID: NCT03113955
Last Updated: 2021-12-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
109 participants
INTERVENTIONAL
2017-10-24
2020-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single -arm
A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
2. Male or female of age ≥18 and ≤75 years.
3. Confirmed diagnosis of HCC according to the diagnostic criteria included in the management guideline issued by China's Ministry of Health in 2017.
4. HCC is diagnosed for the first time or recurrence of tumor after surgical or ablation treatment.
5. 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.
6. no previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) for HCC
7. Preserved liver function (Child-Pugh A or B7).
8. ECOG Performance Status 0 or 1.
Exclusion Criteria
2. Macrovascular invasion of main or primary branches of portal vein at entry into the study
3. Any contraindication for TACE treatment
4. Any contraindication for Epirubicin administration
5. Advanced liver disease (bilirubin levels \>2 mg/dl, AST or ALT \>5 times upper limit of normal)
6. Renal failure or insufficient renal function (Creatinine levels \>2 mg/dl)
7. Subject unable to receive MRI examination
8. Pregnant or breast feeding woman, or plan to become pregnant during treatment or within 12 months of treatment
9. couldn't commit reliable birth control measures during treatment or within 12 months of treatment
10. Subject is participating other investigational drug or device clinical trial within 30 days of signing the informed consent
11. Subject is not suitable to participate in the study as judged by investigator
18 Years
75 Years
ALL
No
Sponsors
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Varian Medical Systems
INDUSTRY
Responsible Party
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Principal Investigators
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Cathy Peng
Role: STUDY_DIRECTOR
BSC China
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Guangdong Nanfang Hospital
Guangzhou, Guangdong, China
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
Countries
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References
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Wang W, Zhang S, Zhong B, Cai W, Gao L, Li B, Yao D, Zhao Y, Sun Z, Zhou S, Zhang T, Chen X, Ju S, Wang YC. Dynamic changes of radiological and radiomics patterns based on MRI in viable hepatocellular carcinoma after transarterial chemoembolization. Abdom Radiol (NY). 2025 May;50(5):2110-2120. doi: 10.1007/s00261-024-04676-z. Epub 2024 Nov 15.
Zhu HD, Li X, Sun JH, Zhu X, Liu ZY, Li HL, Lu J, Yan ZP, Shao GL, He XF, Chao M, Lu LG, Zhong BY, Li R, Zhang Q, Teng GJ. Transarterial Chemoembolization with Epirubicin-Loaded Microspheres for Hepatocellular Carcinoma: A Prospective, Single-Arm, Multicenter, Phase 2 Study (STOPPER Trial). Cardiovasc Intervent Radiol. 2024 Mar;47(3):325-336. doi: 10.1007/s00270-024-03666-4. Epub 2024 Feb 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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S2382
Identifier Type: -
Identifier Source: org_study_id