Clinical trial · Interventional
TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma
Phase II Trail of TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma
NCT01605734CI-TRIAL-00006990unknownPhase 2ClinicalTrials.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)
TACE is widely used in patients with unresectable HCC. However, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed. Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that the combination of TACE with sorafenib could improve the survival of patients with unresectable HCC.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| PHENYTOIN/SORAFENIB [VA Drug Interaction] | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sorafenib combined with TACE | Drug | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group TACE
- description
- TACE will be carried out with chemotherapeutic agents and lipiodol; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated if clinically indicated
- interventionNames
- Procedure: TACE
- type
- EXPERIMENTAL
- label
- Group Combination
- description
- All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study
- interventionNames
- Drug: sorafenib combined with TACE
Primary outcomes (1)
- measure
- Time to Progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria. * BCLC stage B or C * Child-Pugh class score≤8 * ECOG performance status ≤2 * Etiology: Hepatitis B virus(HBV) infection * Written informed consent (approved by the Institutional Review Board \[IRB\]obtained prior to any study specific screening procedures * Patient must be able to comply with the protocol * Age 18-75 years * Haematology:Absolute neutrophil count (ANC) \> 1.5 x 109/L, Platelet count \> 50 x 109/L, Haemoglobin \> 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio \< 1.5 * Biochemistry:Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\< 5 x the upper limit of normal,Total bilirubin \< 3 x the upper limit of normal,Serum creatinine \< 1.5 x the upper limit of normal,Cholinesterase\>0.5x the lower limit of normal，Prealbumin\>0.5x the lower limit of normal. * Life expectancy of \> 3 months Exclusion Criteria: * BCLC stage D * Child-Pugh Score≥9 * Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment * Preexisting or history of hepatic encephalopathy * uncontrolled hypertension * Pregnancy (positive serum pregnancy test) or lactation * Serious, non-healing wound, ulcer, or bone fracture * Currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study * Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication * Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Sorafenib/TACE or patient at high risk from treatment complications * Other severe concomitant disease that may reduce life expectancy * Risk of allergic reactions to the study drugs * Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results
References
Publications (0)
Data not yet available
No reference posted for this study.