Phase 2
N=47
Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer
Hepatocellular Carcinoma · Liver Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01264705 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Median Radiographic Time to Progression (TTP) Calculated From Treatment Initiation to First Evidence of Disease Progression or Last Follow-up. — 6.7 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bavituximab (0.3 mg/kg) and sorafenib (Drug); bavituximab (1.0 mg/kg ) and sorafenib (Drug); bavituximab (3.0 mg/kg) and sorafenib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Radiographic Time to Progression (TTP) Calculated From Treatment Initiation to First Evidence of Disease Progression or Last Follow-up. |
6.7 | — |
| PRIMARY Number of Patients With Dose Limiting Toxicity |
0; 0; 0 | — |
| SECONDARY Safety, as Measured by the Number of Patients With Adverse Event Related to the Treatment That Experienced Grade 3 or Greater. |
0; 0; 0 | — |
| SECONDARY Median Months of Overall Survival Calculated From Treatment Initiation to Death or Last Follow-up. |
6.1 | — |
| SECONDARY Median Months of Disease Specific Survival Calculated From Treatment Initiation to Death From Advanced HCC (Hepatocellular Carcinoma) or Last Follow-up. |
8.6 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01264705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.