A Randomized Phase III Study of Oxaliplatin (Eloxatin) and Capecitabine on Top of Sorafenib Versus Sorafenib Alone as First-line Palliative Treatment in Advanced Hepatocellular Carcinoma Patients
Overview
- Phase
- Phase 3
- Intervention
- oxaliplatin (SR96669)
- Conditions
- Hepatic Neoplasm Malignant
- Sponsor
- Sanofi
- Primary Endpoint
- Overall Survival (OS)
- Status
- Withdrawn
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SECOX regimen
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)
Intervention: oxaliplatin (SR96669)
SECOX regimen
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)
Intervention: capecitabine
SECOX regimen
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)
Intervention: sorafenib
Sorafenib alone
Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)
Intervention: sorafenib
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: 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 Outcomes
- Progression Free Survival (PFS)(From the date of randomization to the date of documentation of progression or death.)
- Response Rate (RR)(From the date of randomization to the end of study.)