A Phase 3 interventional study of oxaliplatin (SR96669) and capecitabine in Hepatic Neoplasm Malignant, sponsored by Sanofi. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-11-09.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Primary Objective:
Secondary Objective:
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
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Exclusion criteria:
Clinically diagnosed subjects who did not meet two following criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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)
Drug: oxaliplatin (SR96669) · Drug: capecitabine · Drug: sorafenib
Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)
Drug: sorafenib
Pharmaceutical form:injection Route of administration: intravenous
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Overall Survival (OS)
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.
Time frame: From the date of randomization to the date of death due to any cause.
Progression Free Survival (PFS)
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.
Time frame: From the date of randomization to the date of documentation of progression or death.
Response Rate (RR)
defined as the proportion of patients with confirmed complete response (CR) or confirmed partial response (PR), defined by RECIST 1.1 criteria
Time frame: From the date of randomization to the end of study.
No study locations are listed for this record.
This study is withdrawn, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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