Clinical trial · Interventional
Sorafenib With Capecitabine and Oxaliplatin for Advanced or Metastatic Hepatocellular Carcinoma
A Phase IIa Trial of Sorafenib With Capecitabine and Oxaliplatin in Patients With Locally Advanced or Metastatic 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)
HCC is an aggressive, largely chemo-resistant cancer with a poor prognosis, currently there is no effective systemic chemotherapy for HCC. Epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) are both overexpressed in HCC and thought to contribute to tumor development. Oxaliplatin in combination with other chemotherapies or biologic agents have been shown to be an effective and safe treatment in advanced HCC patients. Sorafenib, an oral multi-kinase inhibitor, blocks tumor cell proliferation by targeting multiple growth factor pathways and also exerts an anti-angiogenic effect. Clinically, single agent Sorafenib has been shown to have some efficacy in patients with advanced HCC and the primary result of prolonged overall survival seems to have been achieved in the phase III trial.
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 |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib with Capecitabine and Oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- All subjects will receive Sorafenib with Capecitabine and Oxaliplatin
- interventionNames
- Drug: Sorafenib with Capecitabine and Oxaliplatin
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 4 cycles
Secondary outcomes (1)
- measure
- Tumor response rate, overall survival and safety of the regimen in HCC patients
- timeFrame
- 8 cycles
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with locally advanced or metastatic HCC not suitable surgical or locoregional therapies * Age more than 18 years * Performance status 0 or 1 * Life expectancy of 3 months * Prior radiotherapy more than 3 weeks prior to study entry * No prior systemic therapy * Hb more than 8.5 g/dl * ANC more than 1,500/mm3 * PLT more than 75 x 109/L * PT-INR/PTT less than 1.5 x upper limit of normal * Total bilirubin of less than 1.5 x upper limit of normal * Serum creatinine less than 1.5 x upper limit of normal * Serum AST and ALT less than 2.5 x upper limit of normal Exclusion Criteria: * History of cardiac disease * Symptomatic metastatic brain or meningeal tumors * Main portal vein tumor thrombosis * Ascites uncontrolled by medication * Variceal or gastrointestinal bleeding within three months prior to start of treatment * Seizure disorder requiring medication * Patients undergoing renal dialysis * Previous or concurrent cancer that is distinct in primary site * Prior use of any systemic anti-cancer treatment * Prior use of Raf-kinase inhibitors (RKI), VEGF inhibitors, MEK inhibitors or Farnesyl transferase inhibitors * Patients on any local ablative treatment or TACE within 6 weeks * Radiotherapy during study or within 3 weeks * Major surgery within 4 weeks * Concomitant treatment of rifampin or St John's Wort * Pregnant or breast-feeding patients
References
Publications (0)
Data not yet available