Spots Global Cancer Trial Database for Oxaliplatin and Capecitabine on Top of Sorafenib Versus Sorafenib Alone in Advanced Hepatocellular Carcinoma Patients

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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