Clinical trial · Interventional
TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma
Transarterial Embolization and Microwave Ablation Combination Therapy in Early-stage Hepatocellular Carcinoma: A Randomized Trial
NCT02704130CI-TRIAL-00057973terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
This is a single-center, prospective RCT to study the effectiveness of TACE and MWA combination therapy with MWA monotherapy for the treatment of early HCC. Primary outcome is 2-year intrahepatic disease-free survival.
Conditions
Conditions (5)
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 | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatoma | Hepatocellular Carcinoma | ALIAS | 0.90 |
| Liver Cancer, Adult | Malignant Liver Neoplasm | CURATED_EXACT | 0.85 |
| Liver Cell Carcinoma | Hepatocellular Carcinoma | ALIAS | 0.90 |
| Liver Cell Carcinoma, Adult | Hepatocellular Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microwave Ablation | Procedure | — | UNRESOLVED |
| Transarterial embolization | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TAE + MWA combination therapy
- description
- In patients randomized to receive the experimental therapy, transarterial embolization (TAE) treatments will be initiated within one week of randomization. Blunt embolization will be performed with LC beads with a maximum size of 700 µm. Microwave ablation (MWA) will be performed up to one month following randomization. The LC beads will be admixed with 8-15 mL of contrast and injected into the arterial branch at a rate of 1-2 mL/min. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request.
- interventionNames
- Device: Transarterial embolization
- Procedure: Microwave Ablation
- type
- ACTIVE_COMPARATOR
- label
- MWA monotherapy
- description
- Microwave ablation (MWA) will be performed up to one month following randomization. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request. All operative MWAs will be performed in a laparoscopic or robot-assisted laparoscopic setting. All ablations will be guided by intraoperative ultrasound. Ablations will be performed with a 2.45-GHz generator with a 1.8-mm-diameter transcutaneous antenna.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Primary diagnosis of hepatocellular carcinoma (HCC) * HCC classification of stage 0 (very early) or stage A (early) according to Barcelona Clinic Liver Cancer (BCLC) staging system criteria * Adequate clinical condition to undergo laparoscopic or robot-assisted laparoscopic transarterial embolization (TAE) and/or microwave ablation (MWA) as treatment for HCC * Willing and able to give informed consent Exclusion Criteria: * Radiologic (computed tomography or magnetic resonance imaging) evidence of invasion into major portal/hepatic venous branches and no extrahepatic metastases * Evidence of residual disease at first post-MWA computed tomography examination * Body Mass Index (BMI) \> 35 * Previous history of hepatic resections * Severe renal dysfunction (creatinine clearance of \<40 mL/min) * Pregnant or nursing women
References
Publications (0)
Data not yet available
No reference posted for this study.