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Sorafenib and Bavituximab Plus SBRT in Unresectable Hepatocellular Carcinoma

NCT02989870 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-06-05

No results posted yet for this study

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

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).

Sponsors & Collaborators

Principal Investigators

  • Jessica Frakes, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-27
Primary Completion
2018-10-15
Completion
2018-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02989870 on ClinicalTrials.gov