A Study of Capecitabine (Xeloda) and Peginterferon Alfa-2a (Pegasys) in Treatment-Naive Participants With Advanced Liver Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Capecitabine; Drug: Peginterferon alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT02576964

ML18269

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Capecitabine + Peginterferon alfa-2a

Experimental group

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.

Treatment:

Drug: Peginterferon alfa-2a

Drug: Capecitabine