Status:
WITHDRAWN
Oxaliplatin and Capecitabine on Top of Sorafenib Versus Sorafenib Alone in Advanced Hepatocellular Carcinoma Patients
Lead Sponsor:
Sanofi
Conditions:
Hepatic Neoplasm Malignant
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 pr...
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 e...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects with histologically or cytologically or clinically diagnosed advanced HCC not amenable to surgical or local treatment. Documentation of original pathology for diagnosis is acceptable if tumor tissue is unavailable at screening.
- Signed written informed consent
- Exclusion criteria:
- Clinically diagnosed subjects who did not meet two following criteria:
- cirrhotic patients with focal lesion \> 2cm with arterial hypervascularization demonstrated by 2 coincident imaging techniques
- cirrhotic patients with focal lesion \> 2cm with arterial hypervascularization demonstrated by 1 imaging technique and associated with Alpha Fetoprotein (AFP) level \> 400 ng/mL
- Subjects who are receiving or previously received any other investigational therapy or any other systemic anti-cancer treatment for HCC including chemotherapy, immunotherapy or targeted agents, except radiotherapy to non-target lesion (bone metastasis, etc) and HCC adjuvant therapy which was completed more than 6 months prior to randomization. Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior to randomization.
- Subjects with main portal vein thrombosis.
- Subjects with encephalopathy or history of encephalopathy, ascites uncontrolled by medication, active or history of variceal or gastrointestinal bleeding within 30 days
- Subjects with Central Nervous System (CNS) metastasis
- Subjects without one target tumor lesion that be measurable at baseline according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria
- Subjects who have received local therapy such as surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection within 4 weeks prior to randomization
- Subjects with Child-Pugh \> A
- Eastern Cooperative Oncology Group (ECOG) \> 2
- Subjects with inadequate bone marrow, liver and renal function
- Subjects with previous liver transplantation
- Subjects with other serious diseases or medical conditions within 6 months that might be associated with a life expectancy of less than 3 months
- Subjects with other malignant disease previously or concurrently, except cured basal cell carcinoma of skin, cervical carcinoma in situ or any cancer curatively treated \> 3 years prior to study entry
- Subjects with known severe hypersensitivity to sorafenib or any other component of sorafenib
- Pregnant or lactating women, or women of child bearing potential without contraceptive method or unwilling to take effective contraception during the study
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01245582
Start Date
July 1 2011
End Date
August 1 2015
Last Update
November 9 2011
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