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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02576964

Enrollment

Registered

2015-10-15

Start date

2005-01-31

Completion date

2008-11-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular

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.

Interventions

DRUGCapecitabine

Participants will receive oral capecitabine, 1000 mg/m\^2 twice daily on Days 1 to 14 of each 21-day cycle, for at least 6 cycles (18 weeks). Treatment may continue until disease progression, intolerable toxicity, or consent withdrawal.

DRUGPeginterferon alfa-2a

Participants will receive SC peginterferon alfa-2a, 180 mcg every week during each 21-day cycle, for at least 6 cycles (18 weeks). Treatment may continue until disease progression, intolerable toxicity, or consent withdrawal.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Objective response rate	up to post-chemotherapy follow-up ( approximately 46 months)

Secondary

Measure	Time frame
Time to disease progression	Up to approximately 46 months
Duration of response	Up to approximately 46 months
Overall survival	Up to approximately 46 months
Incidence of adverse events	Up to approximately 46 months

Countries

China, Taiwan, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026