Hepatic Neoplasm Malignant Clinical Trial
Official title:
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
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
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment