Localized Hepatocellular CarcinomaNCT03113955
STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
A study testing Tandem Microsphere loaded with Epirubicin in people with Localized Hepatocellular Carcinoma, run by Varian Medical Systems at 10 sites in China.
Trial summary
A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Localized Hepatocellular Carcinoma
- What is being tested?
- Tandem Microsphere loaded with Epirubicin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 10 sitesChina
- Study dates
- 24 Oct 2017to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Guangdong Nanfang Hospital
Guangzhou, Guangdong
Second Aff. Hosp. of Zhejiang University College of Medicine
Hangzhou, Zhejiang
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Zhongda Hospital Affiliated Southeast University
Nanjing, Jiangsu
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality
Shengjing Hospital Affiliated China Medical University
Shenyang, Liaoning
Henan Cancer Hospital
Zhengzhou, Henan
About this study
Official title: A Single-arm Trial of Transcatheter Arterial Chemoembolization 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
Read the 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).
- Conditions
- Localized Hepatocellular Carcinoma
- Being tested
- Tandem Microsphere loaded with Epirubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tandem Microsphere loaded with EpirubicinDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| single -arm | Experimental | A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Receives: Device: Tandem Microsphere loaded with Epirubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months
Secondary outcomes (7)
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
Measured: At 12 months
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.
Measured: At 1month
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.
Measured: from first TACE to 12 months
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.
Measured: from first TACE to 12 months
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
Measured: in 12 months
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.
Measured: At 3 months
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
Measured: At 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start24 Oct 2017
- Primary completion28 Jun 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Localized Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Varian Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cathy Peng, Study director, BSC China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113955
- Sponsor's protocol ID
- S2382
- Status last verified
- Nov 2021
- First submitted
- 6 Mar 2017
- Last updated
- 1 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang S, Wang W, Zhang X, Zhong B, Feng F, Cai W, Li B, Menon VA, Zhou S, Zhang T, Chen X, Ju S, Wang YC. The nVR model: prediction of LI-RADS treatment response nonviable recurrence of hepatocellular carcinoma after primary transarterial chemoembolization. Abdom Radiol (NY). 2025 Nov;50(11):5197-5210. doi: 10.1007/s00261-025-04924-w. Epub 2025 Apr 11.
PubMed 40214697Wang 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.
PubMed 39542948Zhu 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.
PubMed 38413420
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Trial of Transcatheter Arterial Chemoembolization With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03113955
- Acronym / sponsor ID
- S2382
- Conditions
- Localized Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Varian Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Posted 19 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single -arm | Experimental | Device: Tandem Microsphere loaded with EpirubicinA Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tandem Microsphere loaded with EpirubicinThe 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) | Device | single -arm |
Primary outcome
Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)
Time frame: 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.
7 secondary outcomes
Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months
Time frame: At 12 months
Number of Participants With Objective Tumor Response at 30-day
Time frame: At 1month
Kaplan-Meier Analyses the Percent of Participants for PPF(Proportion Progression-Free) at 12 Months
Time frame: from first TACE to 12 months
Kaplan-Meier Analyses the Percent of Participants for Overall Survival
Time frame: from first TACE to 12 months
Number of Adverse Events Relate to Study Device in 12 Months Post Procedure
Time frame: in 12 months
Number of Participants With Objective Tumor Response at 3 Months
Time frame: At 3 months
Kaplan-Meier Analyses the Percent of Participants for Time to Extrahepatic Spread
Time frame: At 12 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40214697Zhang S, Wang W, Zhang X, Zhong B, Feng F, Cai W, Li B, Menon VA, Zhou S, Zhang T, Chen X, Ju S, Wang YC. The nVR model: prediction of LI-RADS treatment response nonviable recurrence of hepatocellular carcinoma after primary transarterial chemoembolization. Abdom Radiol (NY). 2025 Nov;50(11):5197-5210. doi: 10.1007/s00261-025-04924-w. Epub 2025 Apr 11.
- Derived from this study: PubMed 39542948Wang 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.
- Derived from this study: PubMed 38413420Zhu 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.
- Individual participant dataSharing planned: No
Related trials for Localized Hepatocellular Carcinoma
RecruitingPhase 4
Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study
Advanced Biliary Tract Carcinoma, Advanced Head and Neck Squamous Cell Carcinoma
Recruiting
Prevention of Bile Leakage After Liver Resection in Children
Postoperative Bile Leak, Focal Liver Lesions
RecruitingPhase 2
Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis
Hepatocellular Carcinoma
RecruitingPhase 2
Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria
Hepatocellular Carcinoma (HCC), Radioembolization
Not yet recruiting
Pragmatic RCT of AI-Assisted Reading for Malignant Hepatic Lesions on CE-CT
Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy Peng study director
BSC China
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tandem Microsphere loaded with Epirubicin in people with Localized Hepatocellular Carcinoma, run by Varian Medical Systems at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging) (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03113955, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.