Clinical trial · Interventional
Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma
NCT01556815CI-TRIAL-00006782unknownPhase 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)
Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may benefit from sorafenib in combination with TACE.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Digestive System Neoplasms | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| DOXORUBICIN/TRASTUZUMAB [VA Drug Interaction] | — | UNRESOLVED | — |
| HBV | — | UNRESOLVED | — |
| Liver Diseases | — | UNRESOLVED | — |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasms by Histologic Type | — | UNRESOLVED | — |
| Neoplasms by Site | Neoplasm by Site | ONTOLOGY_EXACT |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib in combination with TACE | Other | — | UNRESOLVED |
| Transarterial Chemoembolization (TACE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group TACE
- description
- Patients who undergo TACE
- interventionNames
- Procedure: Transarterial Chemoembolization (TACE)
- type
- EXPERIMENTAL
- label
- Group Combination
- description
- Patients who are treated with sorafenib combined with TACE
- interventionNames
- Other: Sorafenib in combination with TACE
Primary outcomes (1)
- measure
- Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 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 * Child-Pugh class A * ECOG performance status of 0 * 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 18-80 years * Haematology:Absolute neutrophil count (ANC) \> 1 x 109/L, Platelet count \> 40 x 109/L, Haemoglobin \> 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio \< 1.5 * Biochemistry:Total bilirubin \< 2 mg/dL Serum creatinine \< 1.5 x the upper limit of normal * Life expectancy of \> 3 months Exclusion Criteria: * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5 x the upper limit of normal * Other severe concomitant disease that may reduce life expectancy * uncontrolled hypertension * Pregnancy (positive serum pregnancy test) or lactation * Uncontrolled hypertension * 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
References
Publications (0)
Data not yet available
No reference posted for this study.