Clinical trial · Interventional
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
NCT03113955CI-TRIAL-00055318completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tandem Microsphere loaded with Epirubicin | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single -arm
- description
- A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
- interventionNames
- Device: Tandem Microsphere loaded with Epirubicin
Primary outcomes (1)
- measure
- Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)
- timeFrame
- At 6 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. 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is able to provide informed consent and must sign the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent Form. 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: 1. Presence of vascular invasion or extra-hepatic spread of disease, or diffuse HCC, defined as \>50% liver involvement , or arteriovenuous fistula 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
References
Publications (3)
- DERIVEDZhang 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. PMID 40214697
- DERIVEDWang 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. PMID 39542948
- DERIVEDZhu 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. PMID 38413420