CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
gemcitabine hydrochloride +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00941967
NCT00941967Phase 2Completed

Randomized Phase II Trial Assessing the Combination of Nexavar® (Sorafenib), and Gemcitabine/Oxaliplatin in Patients Treated for Advanced (Unresectable/Metastatic) Hepatocellular Carcinoma.

Institut du Cancer de Montpellier - Val d'Aurelle·interventional·Posted Jul 20, 2009·Updated Jul 10, 2019

In Brief

A Phase 2 clinical trial evaluating gemcitabine hydrochloride, oxaliplatin, and 1 other intervention for Liver Cancer. Completed, enrolled 78 participants across 1 site.

Detailed Summary

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether sorafenib tosylate is more effective when given with or without gemcitabine hydrochloride and oxaliplatin in treating patients with liver cancer. PURPOSE: This randomized phase II trial is studying sorafenib tosylate to see how well it works when given with or without gemcitabine hydrochloride and oxaliplatin in treating patients with locally advanced, unresectable, or metastatic liver cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cancer
CountriesFrance
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 20, 2009
Enrollment StartDec 1, 2008
Primary CompletionDec 1, 2010
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.9 years ago

Interventions

gemcitabine hydrochloridedrug

Given IV

oxaliplatindrug

Given IV

sorafenib tosylatedrug

Given orally.