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Oxaliplatin and Capecitabine on Top of Sorafenib Versus Sorafenib Alone in Advanced Hepatocellular Carcinoma Patients

NCT01245582 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2011-11-09

No results posted yet for this study

Summary

Primary Objective:

\- To evaluate the efficacy of SECOX regimen by adding oxaliplatin plus capecitabine to sorafenib versus sorafenib alone as palliative treatment for unresectable HCC patients to prolong overall survival (OS) for advanced HCC patients.

Secondary Objective:

* To compare the efficacy of SECOX regimen with Sorafenib alone for progression free survival (PFS)
* To compare the efficacy of SECOX regimen with Sorafenib alone for response rate (RR)
* To assess the overall safety profile of SECOX regimen in comparison of Sorafenib alone

Conditions

  • Hepatic Neoplasm Malignant

Interventions

DRUG

oxaliplatin (SR96669)

Pharmaceutical form:injection Route of administration: intravenous

DRUG

capecitabine

Pharmaceutical form:tablet Route of administration: oral

DRUG

sorafenib

Pharmaceutical form:tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-02-28
Completion
2015-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01245582 on ClinicalTrials.gov