This trial is active, not recruiting.

Conditions hepatocellular carcinoma, liver cancer
Treatment bavituximab and sorafenib
Phase phase 1/phase 2
Sponsor University of Texas Southwestern Medical Center
Start date January 2011
End date December 2016
Trial size 56 participants
Trial identifier NCT01264705, STU 062010-150


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 activated at the UT Southwestern Medical Center, comprised of The Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Hospitals-St. Paul and Parkland Memorial Hospital System. Advanced HCC is defined as disease that is not amenable to surgical resection or orthotopic liver transplantation or is metastatic in nature.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
bavituximab and sorafenib
Bavituximab:0.3,1.0,and 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily

Primary Outcomes

Safety as measured by the number of participants with adverse events.
time frame: The phase I component is expected to be complete within 3 months.
Time to Progression (phase II)as measured by abdominal magnetic resonance imaging.
time frame: The phase II component is expected to be complete within 2 years.

Secondary Outcomes

Overall Survival.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. 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. 2. Locally advanced or metastatic disease. 3. 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. 4. 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. 5. Child-Pugh Score A. 6. Age ≥ 18 years. 7. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2. 8. Absolute neutrophil count ≥ 1,500 cells/mm3. 9. Platelet count ≥ 75,000 cells/mm3. 10. Total bilirubin ≤ 3.0 mg/dl. 11. Hemoglobin ≥ 8.5 g/dl. 12. AST and ALT ≤ 5.0 times upper limit of normal. 13. D-dimer ≤ 3 times upper limit of normal. 14. INR ≤ 1.8 (therapeutic anticoagulation allowed as long as medically indicated. Exclusion Criteria: 1. History of bleeding diathesis or coagulopathy. 2. Symptomatic or clinically active brain metastases. 3. Major surgery within previous 4 weeks. 4. History of thromboembolic events (including both pulmonary embolisms and deep vein thrombosis); central venous catheter-related thrombosis > 6 months prior is allowed. 5. 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.

Additional Information

Official title A Phase I/II Study of Bavituximab and Sorafenib In Patients With Advanced Hepatocellular Carcinoma
Principal investigator Adam C Yopp, MD
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 but not limited to transarterial chemoembolization (TACE), radiofrequency ablation (RFA) or ethanol injection is allowed as long as the treatment was 4 weeks previous. Patients must be Child-Pugh A with no previous treatment with sorafenib or other vascular endothelial growth factor (VEGF) inhibitors.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center.
Location data was received from the National Cancer Institute and was last updated in March 2016.