Clinical trial · Interventional
TACE With Thermosensitive Nanogel Versus Embosphere for HCC
Safety and Efficacy of TACE With Thermosensitive Nanogel Embolic Agent Versus Embosphere for Hepatocellular Carcinoma: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial
NCT06593964CI-TRIAL-00080488recruitingN/AClinicalTrials.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)
To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.
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 |
|---|---|---|---|
| Unresectable Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thermosensitive Nanogel Embolic Agent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TACE with Thermosensitive Nanogel Embolic Agent
- description
- Equipment: Thermosensitive Nanogel Embolic Agent
- interventionNames
- Device: Thermosensitive Nanogel Embolic Agent
- type
- ACTIVE_COMPARATOR
- label
- TACE with Embosphere Microspheres
- description
- Equipment: Embosphere Microspheres
- interventionNames
- Device: Thermosensitive Nanogel Embolic Agent
Primary outcomes (1)
- measure
- Disease control rate (DCR)
- timeFrame
- One month after the last TACE
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Chinese Liver Cancer Staging Scheme, stage IIb-Illa, as well as those with stage Ia-Ila HCC, unsuitable or unwilling to undergo surgical resection, transplantation, or ablation; 2. Liver function status: Child-Pugh A or B 3. Eastern Cooperative Oncology Group score: 0-2 points; 4. With at least one measurable, unembolized liver tumor lesion (1-10 cm) ; 5. Willing to participate in this trial and sign the informed consent. Exclusion Criteria: 1. The target lesion has been embolized before or require combined with other treatment(s); 2. Diffuse or with extrahepatic metastasis; 3. Coagulation dysfunction (PT prolonged beyond the upper limit of normal for 3 seconds); 4. Severe renal dysfunctions (creatinine clearance rate \<30 ml/min); 5. Severe liver dysfunctions (alanine aminotransferase or aspartate aminotransferase exceeding the upper limit of normal by 5 times); 6. Main portal vein was completely occluded and no collateral blood supply was established; 7. With uncorrectable arteriovenous fistula or portal vein fistula; 8. Severe cachexia or hepatic encephalopathy; 9. With active infection; 10. Significant reductions in white blood cells or platelets (white blood cells\<3.0x109/L, platelets\<50x109/L) that cannot be corrected; 11. Pregnant or lactating women; 12. Difficulty in selective catheterization; 13. With the severe risk of non-target embolization; 14. Severely allergic to contrast agents or the embolic materials; 15. Participating in ongoing trial; 16. Unsuitable judged by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.