Clinical trial · Interventional
A Study of Capecitabine (Xeloda) and Peginterferon Alfa-2a (Pegasys) in Treatment-Naive Participants With Advanced Liver Cancer
An Open-Label Phase II Study of Capecitabine in Combination With Pegylated Interferon Alfa-2a in Patients With Advanced Hepatocellular Carcinoma
NCT02576964CI-TRIAL-00024666completedPhase 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)
This study will evaluate the efficacy and safety of capecitabine (Xeloda) in combination with peginterferon alfa-2a (Pegasys) in participants with advanced liver cancer who have had no prior treatment. The anticipated time on study treatment is until disease progression, and the target sample size is 43 individuals.
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Peginterferon alfa-2a | Drug | Peginterferon Alfa-2a | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine + Peginterferon alfa-2a
- description
- Treatment-naive participants with advanced liver cancer will receive combination treatment with capecitabine (1000 milligrams per meter-squared \[mg/m\^2\] twice daily orally on Days 1 to 14 of each 21-day cycle) and peginterferon alfa-2a (180 micrograms (mcg) subcutaneous \[SC\] every week during each 21-day cycle) until at least 6 cycles (18 weeks) or disease progression, intolerable toxicity, or consent withdrawal.
- interventionNames
- Drug: Capecitabine
- Drug: Peginterferon alfa-2a
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- up to post-chemotherapy follow-up ( approximately 46 months)
Secondary outcomes (4)
- measure
- Time to disease progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Adults 18 to 75 years of age * Locally advanced or metastatic liver cancer with measurable disease and not eligible for any standard therapy Exclusion Criteria: * Previous treatment for liver cancer * Main portal vein involvement * Bone, brain, or leptomeningeal metastasis * Clinically significant cardiac disease * Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract * History of other cancer, except basal cell skin cancer or in situ cancer of the cervix
References
Publications (0)
Data not yet available
No reference posted for this study.