NCT00703365

Brief Summary

This study is to evaluate the efficacy and safety of Sorafenib in combination with Gemcitabine in patients with advanced/unresectable HCC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2008

Typical duration for phase_2

Geographic Reach
1 country

3 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

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 23, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 29, 2011

Status Verified

August 1, 2011

Enrollment Period

1.9 years

First QC Date

May 20, 2008

Last Update Submit

August 25, 2011

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy (progression free survival (PFS)) of sorafenib in patients with advanced/unresectable HCC.

    2.5 years

Secondary Outcomes (1)

  • To evaluate overall, survival, overall response rate (RECIST), time to progression (TTP), disease control rate (DCR) and side-effect profile of sorafenib in combination with gemcitabine in patients suffering from HCC.

    2.5 years

Study Arms (1)

1

EXPERIMENTAL

Sorafenib

Drug: Sorafenib and Gemcitabine

Interventions

Sorafenib and GemcitabineDRUG

Sorafenib 400 mg po bid daily and Gemcitabine IV 1,000 mg/m2 on day 1,8, 15 of a 28-day cycle (up to 6 cycles), then followed by Sorafenib 400 mg po bid daily maintenance until disease progression.

Also known as: Nexavar and Gemzar
1

Eligibility Criteria

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

You may qualify if:

  • patient at least 18 years of age with written informed consent prior to enrollment into the study.
  • histologically or cytologically confirmed advanced unresectable and/or metastasis) HCC
  • Child-Pugh class A or B
  • Have measurable disease according to RECIST criteria
  • life expectancy of at least 12 weeks, ECOG 0-2
  • Have adequate bone marrow reserve and liver and renal function at screening
  • Practice adequate contraception during study participation

You may not qualify if:

  • Exclude medical conditions including history of cardiac disease, HIV infection,active infection,brain metastastasis or intracranial metastasis,seizure disorder requiring medication, history of organ allograft,evidence of or history of bleeding diathesis,previous or concurrent cancer with distinct in primary site or histology (with exception of cervical carcinoma in situ and treated basal cell carcinoma
  • Excluded therapies and medications, previous and concomitant : prior systemic anticancer chemotherapy or immunotherapy or targeted therapy,hormonal therapy within 2 weeks,local treatment modality within 4 weeks,radiotherapy within 3 weeks,major surgery and unhealed wound within 4 weeks,autologous bone marrow transplant or stem cell rescue within 4 months
  • other condition that may interfere with the patient's participation in the study or evaluation of the results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Medicine, Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Medical Oncology Unit, Chulalongkorn Hospital

Patumwan, Bangkok, 10330, Thailand

Location

Horizon Regional Cancer Center, Bamrungrad Hospital

Sukhumvit, Bangkok, 10110, Thailand

Location

Related Publications (1)

  • Louafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taieb J. Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study. Cancer. 2007 Apr 1;109(7):1384-90. doi: 10.1002/cncr.22532.

    PMID: 17330837BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

SorafenibGemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingDeoxycytidineCytidinePyrimidine NucleosidesPyrimidines

Study Officials

  • Vichien Srimuninnimit, Assist.Prof.

    Siriraj Hospital, Bangkok, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 20, 2008

First Posted

June 23, 2008

Study Start

February 1, 2008

Primary Completion

January 1, 2010

Study Completion

August 1, 2011

Last Updated

August 29, 2011

Record last verified: 2011-08

Locations

TH(3)