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A Phase I/II Study of Bavituximab and Sorafenib In Patients With Advanced Hepatocellular Carcinoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma, Liver Cancer

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Trial Information

A Phase I/II Study of Bavituximab and Sorafenib In Patients With Advanced Hepatocellular Carcinoma

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.

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety as measured by the number of participants with adverse events.

Outcome Time Frame:

The phase I component is expected to be complete within 3 months.

Safety Issue:


Principal Investigator

Adam C Yopp, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT Southwestern Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2010

Completion Date:

December 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Cancer
  • Cirrhosis
  • GI Cancer
  • Hepatitis
  • Oncology
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



Ut Southwestern Medical CenterDallas, Texas  75390