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OpenTrials
Completed

NCT Number: NCT02576964

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

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

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.

Other names: Xeloda

Peginterferon alfa-2a

Drug

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.

Other names: Pegasys

Primary outcomes

  1. Objective response rate

    Time frame: up to post-chemotherapy follow-up ( approximately 46 months)

Secondary outcomes

  1. Time to disease progression

    Time frame: Up to approximately 46 months

  2. Duration of response

    Time frame: Up to approximately 46 months

  3. Overall survival

    Time frame: Up to approximately 46 months

  4. Incidence of adverse events

    Time frame: Up to approximately 46 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-Label Phase II Study of Capecitabine in Combination With Pegylated Interferon Alfa-2a in Patients With Advanced Hepatocellular Carcinoma

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 15, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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