Clinical trial · Interventional
Capecitabine to Prevent Recurrence of Hepatocellular Carcinoma After Curative Resection
Capecitabine as Adjuvant Chemotherapy to Prevent Recurrence of Hepatocellular Carcinoma After Curative Resection: a Randomized Controlled Trial
NCT00561522CI-TRIAL-00003690unknownPhase 2 / Phase 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 capecitabine is effective to prevent disease recurrence after curative hepatic resection in patients with hepatocellular carcinoma.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| No other preventive treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention treatment
- description
- Capecitabine
- interventionNames
- Drug: Capecitabine
- type
- NO_INTERVENTION
- label
- No intervention treatment
- description
- No other preventive treatment
- interventionNames
- Other: No other preventive treatment
Primary outcomes (1)
- measure
- The primary end point was to determine the effect on disease-free survival and overall survival by oral capecitabine.
- timeFrame
- four years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * First curative hepatic resection * Hepatocellular Carcinoma (histologically confirmed) * Cirrhosis of Child-Pugh class A or B * A performance status ≤ 2 * Adequate bone marrow ,hepatic and renal functions (white blood cell (WBC) count \> 2.5×10\^3/μL, platelet count \> 40×10\^3/μL, a serum bilirubin level, alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2 times the upper limit of the normal value, and serum creatinine level \< 1.5 mg/dL) * Major organ (heart, lung and brain) function was normal * An age between 18 and 79 years. Exclusion Criteria: * Any active infectious process * Known hypersensitivity to capecitabine * The presence of clinically confirmed extrahepatic metastasis, macroscopic evidence of tumor thrombus in the inferior vena cava or the main portal vein or the main bile duct * Other previous or synchronous malignant disorders * Postoperative dysfunction of any organ.
References
Publications (0)
Data not yet available
No reference posted for this study.