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A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
It is a prospective, single-arm, multicenter study. The primary effectiveness endpoint for this clinical trial is 6-month overall objective tumor response (ORR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single -arm | Experimental | A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tandem Microsphere loaded with Epirubicin | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cathy Peng | BSC China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | China | |||
| Cancer Hospital Chinese Academy of Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40214697 | Derived | 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. | |
| 39542948 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.
| Total enrolled 109 subjects , 7 subjects were not completed 6 months primary endpoint follow up visit and were not included in the per protocol group for analysis. So overall Number of Participants Analyzed were 102. | Posted | Number | participants | At 6 months |
12 months
Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver abscess | Hepatobiliary disorders | Systematic Assessment | There was 6 cases of hepatic abscess reported in the per protocol group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Investigations | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gaojun Teng | Zhongda Hospital Southeast University | 13805171500 | +86 | gjteng@vip.sina.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 23, 2018 | Dec 14, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2019 | Dec 14, 2020 | SAP_001.pdf |
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|
| 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.
| 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:
| 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:
| 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 | 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.
| 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:
| At 12 month |
| 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 |
| 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. |
| 38413420 | Derived | 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. |
| Count of Participants |
| Participants |
| No |
|
| Age, Continuous | A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis. | Geometric Mean | Standard Deviation | years |
|
| Sex: Female, Male | A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis. | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis | Count of Participants | Participants | No |
|
| Region of Enrollment | Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis. | Number | participants |
|
| Child-Pugh Score | Child-Pugh, classification standard is a commonly used clinically to quantitative assessment of the liver reserve function classification standard. when the Child will be five patient's indicators (including the general situation, ascites, the concentration of serum bilirubin, serum albumin, and prothrombin time) of the different states are divided into three levels, 1 point, 2 and 3 points. Five indicators score together, combined the lowest is 5 points, the highest is 15 points, Class A=5 points, Class B=7-9, Class C=10-15, the higher score, the worse the liver reserve function. | A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis. | Count of Participants | Participants | No |
|
| Disease History | Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis. | Count of Participants | Participants | No |
|
| ECOG Performance Status | ECOG Performance: 0 point is fully active, able to carry on all pre-disease performance without restriction; 1 point is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 points is ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 points is Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 points is completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 points is dead. | Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis. | Count of Participants | Participants | No |
|
|
|
|
| Secondary | 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:
| Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis. | Posted | Number | Percent of participants | At 12 months |
|
|
|
| Secondary | 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.
| Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis. | Posted | Count of Participants | Participants | At 1month |
|
|
|
| Secondary | 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:
| Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis. | Posted | Number | Percent of participants | from first TACE to 12 months |
|
|
|
| Secondary | 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:
| Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment, 1 subject withdrew consent from study participation at 6 month, 1 subject withdrew consent from study participation at 12 month. All 3 subjects are not included in the group for overall survival analysis. | Posted | Number | Percent of participants | from first TACE to 12 months |
|
|
|
| Secondary | 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 | Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis. | Posted | Number | adverse events | in 12 months |
|
|
|
| Secondary | 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.
| Total enrolled 109 subjects , 4 subjects were not completed 3 months primary endpoint follow up visit and were not included in the per protocol group for analysis. So overall Number of Participants Analyzed were 105. | Posted | Count of Participants | Participants | At 3 months |
|
|
|
| Secondary | 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:
| Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis. | Posted | Number | Percent of participants | At 12 month |
|
|
|
| 7 |
| 108 |
| 13 |
| 108 |
| 75 |
| 108 |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Hepatic cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Jaundice hepatocellular | Hepatobiliary disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Post embolisation syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| General disorders and administration site conditions | General disorders | Systematic Assessment |
|
| Hepatobiliary disorders | Hepatobiliary disorders | Systematic Assessment |
|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
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