Sorafenib and Bavituximab Plus SBRT in Unresectable Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT02989870|
Recruitment Status : Withdrawn (No Interest. Investigator was unable to enroll any participants on study.)
First Posted : December 12, 2016
Last Update Posted : October 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|HepatoCellular Carcinoma Unresectable HepatoCellular Carcinoma Liver Cancer||Radiation: Stereotactic Body Radiation Therapy (SBRT) Drug: Sorafenib Drug: Bavituximab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for 1st Line Treatment of Unresectable Hepatocellular Carcinoma|
|Actual Study Start Date :||March 27, 2017|
|Actual Primary Completion Date :||October 15, 2018|
|Actual Study Completion Date :||October 15, 2018|
Experimental: SBRT, Sorafenib and Bavituximab
This will be a 3+3 design with 3 dose cohorts. Following the dose escalation phase, an additional 6 patients will be enrolled as part of the dose expansion cohort.
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.
Other Name: radiotherapy
Sorafenib by mouth (PO): 200 mg twice a day (BID) then 400 mg BID.
Bavituximab intravenously (IV): 3 mg/kg every week (q wk).
Other Name: Immunotherapy
- Occurrence of Treatment Related Adverse Events [ Time Frame: From beginning of treatment to 30 days post-treatment, approximately 2 years ]Safety and tolerability, as assessed by presence of adverse events, serious adverse events, dose limiting toxicity (DLTs), abnormal laboratory parameters, vital signs. A DLT is defined as any toxicity not attributable to the disease or disease-related processes under investigation, which occurs from the start of radiation up to 42 days and is considered by the Investigators to be definitely, probably, or possibly related to the treatment. A DLT will be defined as any Grade 3 or higher treatment-related toxicity that occurs during the DLT evaluation period.
- Objective Response Rate (ORR) [ Time Frame: Up to 24 months post treatment ]Tumor response data will be summarized for dosed participants with measurable disease at baseline. Response will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. In addition, the immune response criteria will be utilized.
- Progression Free Survival (PFS) [ Time Frame: Up to 24 months post treatment ]PFS following SBRT, sorafenib, and bavituximab, will be summarized in the expansion phase arm. Progression will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.) In addition, the immune response criteria will be utilized.
- Overall Survival (OS) [ Time Frame: Up to 24 months post treatment ]Overall Survival following SBRT, sorafenib, and bavituximab. OS: The length of time from beginning of study treatment to death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989870
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Jessica Frakes, M.D.||H. Lee Moffitt Cancer Center and Research Institute|