Clinical trial · Interventional
RCT of TAE Simultaneously Combined Thermal Ablation for Large Hepatocellular Carcinoma
Randomized Controlled Trial of Transarterial Embolization Simultaneously Combined Thermal Ablation for Large Hepatocellular Carcinoma
- 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)
This study intends to evaluate the efficacy and safety of Transarterial embolization (TAE) simultaneously combined with thermal ablation for large hepatocellular carcinoma (HCC). Half participants will receive TAE simultaneously combined with thermal ablation and the other half receive TACE sequentially combined with thermal ablation, which is a conventional treatment for HCC patients.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma, Adult | Adult Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ablation | Device | — | UNRESOLVED |
| Chemotherapy drug | Drug | — | UNRESOLVED |
| Embolic agents | Drug | — | UNRESOLVED |
| Sequentially | Procedure | — | UNRESOLVED |
| Simultaneously | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TAE combined ablation simultaneously
- description
- TAE simultaneously combined with ablation.The treatment interval is 1-3 days between two procedures. TAE using embolic agents(Lipiodol/Gelatin sponge/PVA particles(300～500μm)/Blank microspheres).
- interventionNames
- Drug: Embolic agents
- Procedure: Simultaneously
- Device: Ablation
- type
- OTHER
- label
- TACE combined ablation sequentially
- description
- TACE sequentially combined thermal ablation.The treatment interval is 1 month between two procedures. TACE using chemotherapy drug(Doxorubicin/platinum agents) and embolic agents(Lipiodol/Gelatin sponge/PVA particles(300～500μm)/Blank microspheres).
- interventionNames
- Drug: Chemotherapy drug
- Drug: Embolic agents
- Procedure: Sequentially
- Device: Ablation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 to 70 years with estimated survival over 3 months * Number of tumors \< 3 * Diameter of tumor between 5cm to 15cm * No portal vein trunk tumoral thrombus or inferior vena cava tumoral thrombus * With arteriovenous fistula or arterioportal shunt fistula that can be completely embolized * Child-Pugh class A or B/Child score \> 7;ECOG score \< 2 * Tolerable coagulation function or reversible coagulation disorders * Laboratory examination test: WBC≥3.0×10E9/L; Hb≥3.0×10E9/L; PLT ≥50×10E9/L; INR \< 2.3 or PT\< 16.5s; Cr ≤ 145.5 umul/L * Signed informed consent before recruiting Exclusion Criteria: * Diffused HCC * With portal vein trunk tumoral thrombus * With inferior vena cava tumoral thrombus or hepatic vein tumor thrombus * With lymphatic metastasis or extra hepatic metastasis * Child-Pugh class C and can't be improved by expectant treatment * Untreatable coagulation disorders, severe hemogram abnormal and bleeding tendency * Massive intractable ascites * ECOG score \> 2
References
Publications (0)
Data not yet available