Status:
COMPLETED
Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Hepatocellular Carcinoma
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a non-randomized, open-label, single-institution phase I/II therapeutic trial of bavituximab and sorafenib in patients with advanced hepatocellular carcinoma (HCC). This study will be activate...
Detailed Description
The investigators are looking for men or women aged 18 years or older with hepatocellular carcinoma not suitable for surgical resection or hepatic transplantation. Prior locoregional therapy including...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:
- Histologically confirmed.
- MRI or CT consistent with liver cirrhosis and at least one solid liver lesion \>2 cm with early enhancement and delayed enhancement washout regardless of AFP.
- AFP \>400 ng/ml and evidence of at least one solid liver lesion \>2 cm regardless of specific imaging characteristics on CT or MRI.
- Locally advanced or metastatic disease.
- Patients with locally advanced disease must have disease deemed to be unresectable or not eligible for hepatic transplantation. Determination will occur in the weekly GI DMT meeting by surgical oncologists and transplant surgeons.
- Measurable disease, as defined as lesions that can accurately be measured in at least one dimension (longest diameter to be measured) according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at least 2 cm with conventional techniques or at least 1 cm with spiral computed tomography.
- Child-Pugh Score A.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
- Absolute neutrophil count ≥ 1,500 cells/mm3.
- Platelet count ≥ 75,000 cells/mm3.
- Total bilirubin ≤ 3.0 mg/dl.
- Hemoglobin ≥ 8.5 g/dl.
- AST and ALT ≤ 5.0 times upper limit of normal.
- D-dimer ≤ 3 times upper limit of normal.
- INR ≤ 1.8 (therapeutic anticoagulation allowed as long as medically indicated.
Exclusion
- History of bleeding diathesis or coagulopathy.
- Symptomatic or clinically active brain metastases.
- Major surgery within previous 4 weeks.
- History of thromboembolic events (including both pulmonary embolisms and deep vein thrombosis); central venous catheter-related thrombosis \> 6 months prior is allowed.
- Prior adjuvant therapy with sorafenib or other Raf/MEK/RAS or VEGFR inhibitors. Prior adjuvant therapy is allowed provided it was completed \> 6 months ago and there is documented recurrence of hepatocellular carcinoma.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01264705
Start Date
January 1 2011
End Date
April 1 2018
Last Update
November 12 2020
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390