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

Phase 3

Withdrawn

• Conditions: Hepatic Neoplasm Malignant
• Interventions: Drug: oxaliplatin (SR96669); Drug: capecitabine; Drug: sorafenib

• Registration Number: NCT01245582
• Lead Sponsor: Sanofi

Brief 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

Detailed Description

For each patient, the study consists of a baseline period of screening up to 2 weeks, a treatment period with 2 weeks as one study treatment cycle.

Each patient will be randomly assigned to receive either SECOX (Sorafenib, Oxaliplatin with Capecitabine) or Sorafenib alone every 2 weeks until disease progression, intolerable toxicity, or patient's refusal of further study treatment. There will be a 30-day follow-up visit after the last study treatment.

All patients will be follow-up every 2 months until death is observed during post-treatment follow-up period.

Study Timeline

• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Study Start: 2011-07
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-08
• Last Update Posted: 2011-11-09
• Primary Completion: 2014-02
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SECOX regimen	oxaliplatin (SR96669)	Oxaliplatin (Eloxatin) 85mg/m2 , 2 hour infusion, day 1 Capecitabine (Xeloda) 850 mg/m2 BID orally daily, from day 1 to 7 Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)
SECOX regimen	capecitabine	Oxaliplatin (Eloxatin) 85mg/m2 , 2 hour infusion, day 1 Capecitabine (Xeloda) 850 mg/m2 BID orally daily, from day 1 to 7 Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)
SECOX regimen	sorafenib	Oxaliplatin (Eloxatin) 85mg/m2 , 2 hour infusion, day 1 Capecitabine (Xeloda) 850 mg/m2 BID orally daily, from day 1 to 7 Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)
Sorafenib alone	sorafenib	Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From the date of randomization to the date of death due to any cause.	defined as the time from randomization to the date of death due to any cause. If death is not observed at the cut off date, data on OS will be censored at the last date when patient is known to be alive or the cut-off date, whichever comes first.

Secondary Outcome Measures

Name	Time	Method
Response Rate (RR)	From the date of randomization to the end of study.	defined as the proportion of patients with confirmed complete response (CR) or confirmed partial response (PR), defined by RECIST 1.1 criteria
Progression Free Survival (PFS)	From the date of randomization to the date of documentation of progression or death.	defined as the time interval from the date of randomization to the date of first observation of disease progression or the date of death (due to any cause). If death or progression is not observed, data on PFS will be censored at the earlier date of last tumor assessment without evidence of progression and the cut-off date.