NCT02576964

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2005

Typical duration for phase_2

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.8 years

First QC Date

October 14, 2015

Last Update Submit

November 1, 2016

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    up to post-chemotherapy follow-up ( approximately 46 months)

Secondary Outcomes (4)

  • 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

Study Arms (1)

Capecitabine + Peginterferon alfa-2a

EXPERIMENTAL

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.

Drug: CapecitabineDrug: Peginterferon alfa-2a

Interventions

CapecitabineDRUG

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.

Also known as: Xeloda
Capecitabine + Peginterferon alfa-2a
Peginterferon alfa-2aDRUG

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.

Also known as: Pegasys
Capecitabine + Peginterferon alfa-2a

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 to 75 years of age
  • Locally advanced or metastatic liver cancer with measurable disease and not eligible for any standard therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Beijing, 100050, China

Location

Unknown Facility

Guangzhou, 510060, China

Location

Unknown Facility

Kueishan, 333, Taiwan

Location

Unknown Facility

Tainan, 704, Taiwan

Location

Unknown Facility

Bangkok, 10400, Thailand

Location

Unknown Facility

Bangkok, 10700, Thailand

Location

Unknown Facility

Chiang Mai, 50202, Thailand

Location

Unknown Facility

Songkhla, 90112, Thailand

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Capecitabinepeginterferon alfa-2a

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 15, 2015

Study Start

January 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

CN(2)TW(2)TH(4)