Clinical trial · Interventional
Radiofrequency Ablation Combined With Transcatheter Arterial Chemoembolization Versus Radiofrequency Ablation Alone for Recurrent 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)
The combination of transcatheter arterial chemoembolization (TACE) with RFA has also reported to be an effective treatment for HCC. Studies have shown TACE combined RFA to have better efficacy than RFA for medium-sized HCC (3-5 cm) and multiple-tumor HCC, but not for small HCC (≤3 cm). However, to our knowledge, there have not been any prospective studies to assess whether TACE combined sequentially with RFA is more effective than RFA alone for the treatment of HCC recurrence after curative treatment. We hypothesized that the combination of TACE and RFA might result in better patient survival than RFA alone. Thus, the purpose of this study was to prospectively compare the effects of sequential TACE-RFA with RFA alone for the treatment of recurrent HCC. Recurrent HCC in this study was defined as new tumors in the remnant liver, distant from the resection or ablation site after curative treatment of RFA or hepatectomy.
Conditions
Conditions (3)
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 |
| RFA | — | UNRESOLVED | — |
| TACE | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RFA | Procedure | — | UNRESOLVED |
| TACE-RFA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RFA
- description
- For RFA, we used a commercially available system with a 375-KHz computer-assisted radiofrequency generator (Elektrotom HiTT 106, Berchtold, Medizinelektronik, Germany) and an open-perfused electrode (Berchtold, Tuttlingen, Germany) of 15 cm (or 20 cm), 14 Ga, and a 15 mm (or 20 mm) active electrode tip with microbores.
- interventionNames
- Procedure: TACE-RFA
- type
- EXPERIMENTAL
- label
- TACE-RFA
- description
- TACE first, then RFA within 2 weeks
- interventionNames
- Procedure: RFA
Primary outcomes (1)
- measure
- overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. age 18 - 75 years; 2. Distant recurrence of HCC after initial curative treatment (including initial RFA or hepatectomy); 3. no other treatment received except for the initial RFA or hepatectomy; 4. Single tumor less than 4cm in diameter; 5. lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound; 6. no severe coagulation disorders (prothrombin activity \< 40% or a platelet count of \< 40,000 / mm3; 7. Eastern Co-operative Oncology Group performance(ECOG) status 0 - Exclusion Criteria: 1. the presence of vascular invasion or extrahepatic spread on imaging; 2. a Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity \< 40% or a platelet count of \< 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy; 3. an American Society of Anesthesiologists (ASA) score ≥ 3
References
Publications (0)
Data not yet available