Clinical trial · Interventional
Combine TACE and RFA Versus TACE Alone for HCC With PVTT
Combine Transcatheter Arterial Embolization and Radiofrequency Ablation Versus Transcatheter Arterial Embolization Alone for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
NCT02301091CI-TRIAL-00021745CORTTunknownPhase 3ClinicalTrials.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)
The purpose of this study is to determine whether combined radiofrequency ablation and transcatheter chemoembolization (TACE) result in better survival outcomes than TACE alone in patients with HCC and portal vein tumor thrombus.
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 | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pirarubicin,mitomycin and lobaplatin | Drug | — | UNRESOLVED |
| RFA | Procedure | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TACE-RFA
- description
- 2 times TACE first, RFA for residual viable tumors and PVTT within 1 month.
- interventionNames
- Procedure: TACE
- Procedure: RFA
- Drug: pirarubicin,mitomycin and lobaplatin
- type
- ACTIVE_COMPARATOR
- label
- TACE alone
- description
- repeated TACE and 1 to 2 months interval between two sessions of TACE.
- interventionNames
- Procedure: TACE
- Drug: pirarubicin,mitomycin and lobaplatin
Primary outcomes (1)
- measure
- Overall survival rates
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * HCC with portal vein tumor thrombus in the first or second branch * Refused sorafenib or could not tolerate the adverse effect of sorafenib * A solitary HCC ≤ 5.0 cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 5.0 cm in diameter * Eastern Cooperative Oncology Group Performance Status 0-1 * Child-Pugh Score ≤ 8 * A platelet counts of \> 60,000/mm3, hemoglobin\>8.5 g/dL, prothrombin time prolong \<6s * Albumin \>2.8 g/dL, total bilirubin \<51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）\<5 times of upper limit * Sign the informed consent. Exclusion Criteria: * Presence of extrahepatic metastasis except lymph node metastasis * The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed * Uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy; * Severe heart, brain or kidney diseases * Previous or concurrent cancer that is distinct in primary site or histology from HCC * Pregnant women or lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.