Clinical trial · Interventional
SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC
A Combination of Sorafenib, Capecitabine and Oxaliplatin (SECOX) as Neoadjuvant Therapy in Patients With Locally Advanced Hepatocellular Carcinoma: A Phase II Study
NCT03578874CI-TRIAL-00044569completedPhase 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)
The purpose of this study is to evaluate the resectability after treatment with SECOX (sorafenib, capecitabine, oxaliplatin) as neoadjuvant therapy in patients with locally advanced hepatocellular carcinoma
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 |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SECOX
- description
- Sorafenib 400 mg twice daily from Day 1 to 14, Capecitabine 850 mg/m2 twice daily from Day 1 to 7, Oxaliplatin 85 mg/m2 on Day 1
- interventionNames
- Drug: Sorafenib
- Drug: Capecitabine
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Resectability
- timeFrame
- At the end of Cycle 4 (each cycle is 14 days)
- description
- Proportion of patients deemed resectable as assessed by designated hepatobiliary surgeons
Secondary outcomes (3)
- measure
- Objective response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * HCC confined to single lobe of non-cirrhotic liver (locally advanced) and not suitable for surgery or loco-regional therapies at the time of study entry, but can become resectable after treatment * Diagnosis of HCC confirmed by histology * Child-Pugh class A cirrhosis with adequate remnant liver parenchyma * Measurable disease * Fit enough to undergo surgery to resect the primary liver tumour Exclusion Criteria: * Prior systemic therapy for HCC * Presence of extrahepatic metastasis * History of liver transplantation * Peripheral sensory neuropathy with functional impairment * Uncontrolled hypertension/ cardiac disease
References
Publications (0)
Data not yet available
No reference posted for this study.