A Study of Capecitabine (Xeloda) and Peginterferon Alfa-2a (Pegasys) in Treatment-Naive Participants With Advanced Liver Cancer
Phase 2
Completed
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- Registration Number
- NCT02576964
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Capecitabine + Peginterferon alfa-2a Capecitabine 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. Capecitabine + Peginterferon alfa-2a Peginterferon alfa-2a 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.
- Primary Outcome Measures
Name Time Method Objective response rate up to post-chemotherapy follow-up ( approximately 46 months)
- Secondary Outcome Measures
Name Time Method Duration of response Up to approximately 46 months Time to disease progression Up to approximately 46 months Overall survival Up to approximately 46 months Incidence of adverse events Up to approximately 46 months