Trials / Withdrawn
WithdrawnNCT02989870
Sorafenib and Bavituximab Plus SBRT in Unresectable Hepatocellular Carcinoma
A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for 1st Line Treatment of Unresectable Hepatocellular Carcinoma
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study involves a course of radiation to up to 5 tumors in the participant's liver followed by systemic therapy. (Treatment using substances that travel through the bloodstream, reaching and affecting cells all over the body.) The type of radiation is called stereotactic body radiation therapy (SBRT). The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given along with the systemic therapies, sorafenib and bavituximab. The researchers want to see which dose of radiation will work best in stimulating the immune response and provide local control to the participant's liver. The usual treatment for hepatocellular carcinoma that is unresectable can be transarterial therapy, sorafenib alone and/or clinical trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Stereotactic Body Radiation Therapy (SBRT) | Participants will receive 3-5 fractions of radiation as determined by the dose level at time of enrollment. The starting dose level will be Dose Level 1: 8 Gy x 3 fractions for a total of 24 Gy. If sufficient treatment related toxicity is observed at the "initial starting dose", then the dose will be reduced to 16 Gy in 2 fractions of 8 Gy. The dose per fraction for each participant will be provided at the time of registration based on the toxicity experience of the previous participants on study. This will be escalated to 40 Gy in 5 fractions of 8 Gy. |
| DRUG | Sorafenib | Sorafenib by mouth (PO): 200 mg twice a day (BID) then 400 mg BID. |
| DRUG | Bavituximab | Bavituximab intravenously (IV): 3 mg/kg every week (q wk). |
Timeline
- Start date
- 2017-03-27
- Primary completion
- 2018-10-15
- Completion
- 2018-10-15
- First posted
- 2016-12-12
- Last updated
- 2020-06-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02989870. Inclusion in this directory is not an endorsement.