HepatoCellular CarcinomaPhase 1NCT02989870
Sorafenib and Bavituximab Plus SBRT in Unresectable Hepatocellular Carcinoma
A Phase 1 study testing Stereotactic Body Radiation Therapy (SBRT), Sorafenib and Bavituximab in people with HepatoCellular Carcinoma and Unresectable HepatoCellular Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HepatoCellular Carcinoma, Unresectable HepatoCellular Carcinoma, Liver Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT), Sorafenib and Bavituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2017to 15 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced, unresectable hepatocellular carcinoma (unsuitable for resection, transplant or ablation)
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Must have normal organ and marrow function
- Childs-Pugh score of A or B7
- Must have measurable/evaluable disease as per RECIST 1.1 criteria
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- Females of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both males and females, effective methods of contraception must be used throughout the study and for four months following the last dose.
- Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
- Must be able to understand and be willing to sign the written informed consent form
- No more than 10 lesions in the liver
Who cannot join
- Have received radiation therapy, major surgery, other locoregional therapy, within 4 weeks prior to the first date of SBRT
- Prior radiotherapy to the region of the liver that would result in excessive doses to normal tissues due to overlap of radiation therapy fields
- Prior selective internal radiotherapy/hepatic arterial Yttrium therapy, at any time
- Any one hepatocellular carcinoma > 15 cm
- Total maximal sum of hepatocellular carcinomas or a single conglomerate HCC > 20 cm
- Direct tumor extension into the stomach, duodenum, small bowel or large bowel
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- Measureable common or main branch biliary duct involvement with HCC
- Extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) > 3.0 cm, in sum of maximal diameters (e.g., presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions). Note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm.
- Use of regular phenytoin, carbamazepine, hypericum perforatum [also known as St. John's wort] or rifampin
- Have received sorafenib or other systemic therapies for treatment of HCC in the past.
- Active autoimmune disease; Patients with type I diabetes mellitus, hypothyroidism requiring only hormone replacement, psoriasis not requiring systemic treatment, or vitiligo are permitted for enrollment.
- No active malignancy except for nonmelanoma skin cancer or in situ cervical cancer. Patients surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before the trial are allowed.
- Myocardial infarction within past 6 months, congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia
- Congenital long QT syndrome
- Previous stroke within past 12 months
- Anti-coagulant therapy, bleeding or clotting disorder
- Symptomatic metastatic brain or meningeal tumors
- Presence of a non-healing wound, non-healing ulcer, or bone fracture
- History of organ allograft (including corneal transplant)
- Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial
- Women who are pregnant or breast-feeding
- Any condition which, in the investigator's opinion, makes the patient unsuitable for trial participation
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for 1st Line Treatment of Unresectable Hepatocellular Carcinoma
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.
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Sorafenib, Bavituximab
- Keywords
- Liver Disease, Child-Pugh Class A, Child-Pugh Class B7
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Also called radiotherapy
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.
SorafenibDrug
Also called Nexavar, Kinase inhibitor
Sorafenib by mouth (PO): 200 mg twice a day (BID) then 400 mg BID.
BavituximabDrug
Also called Immunotherapy
Bavituximab intravenously (IV): 3 mg/kg every week (q wk).
| Study group | Role | What they receive |
|---|---|---|
| SBRT, Sorafenib and Bavituximab | Experimental | 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. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: Sorafenib; Drug: Bavituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment Related Adverse Events
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.
Measured: From beginning of treatment to 30 days post-treatment, approximately 2 years
Secondary outcomes (3)
Objective Response Rate (ORR)
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.
Measured: Up to 24 months post treatment
Progression Free Survival (PFS)
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.
Measured: Up to 24 months post treatment
Overall Survival (OS)
Overall Survival following SBRT, sorafenib, and bavituximab. OS: The length of time from beginning of study treatment to death from any cause.
Measured: Up to 24 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start27 Mar 2017
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
Why it stopped: No Interest. Investigator was unable to enroll any participants on study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatoCellular CarcinomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Jessica Frakes, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989870
- Sponsor's protocol ID
- MCC-18924
- Status last verified
- Jun 2020
- First submitted
- 8 Dec 2016
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for 1st Line Treatment of Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02989870
- Acronym / sponsor ID
- MCC-18924
- Keywords
- Liver Disease, Child-Pugh Class A, Child-Pugh Class B7
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Interest. Investigator was unable to enroll any participants on study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT, Sorafenib and Bavituximab | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT), Drug: Sorafenib, Drug: BavituximabThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Advanced, unresectable hepatocellular carcinoma (unsuitable for resection, transplant or ablation)
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Must have normal organ and marrow function
- Childs-Pugh score of A or B7
Key exclusion criteria (22 listed)
- Have received radiation therapy, major surgery, other locoregional therapy, within 4 weeks prior to the first date of SBRT
- Prior radiotherapy to the region of the liver that would result in excessive doses to normal tissues due to overlap of radiation therapy fields
- Prior selective internal radiotherapy/hepatic arterial Yttrium therapy, at any time
- Any one hepatocellular carcinoma > 15 cm
- Total maximal sum of hepatocellular carcinomas or a single conglomerate HCC > 20 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)Also: radiotherapyParticipants 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. | Radiation | SBRT, Sorafenib and Bavituximab |
| SorafenibAlso: Nexavar, Kinase inhibitorSorafenib by mouth (PO): 200 mg twice a day (BID) then 400 mg BID. | Drug | SBRT, Sorafenib and Bavituximab |
| BavituximabAlso: ImmunotherapyBavituximab intravenously (IV): 3 mg/kg every week (q wk). | Drug | SBRT, Sorafenib and Bavituximab |
Primary outcome
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.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 24 months post treatment
Progression Free Survival (PFS)
Time frame: Up to 24 months post treatment
Overall Survival (OS)
Time frame: Up to 24 months post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Frakes, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stereotactic Body Radiation Therapy (SBRT), Sorafenib and Bavituximab in people with HepatoCellular Carcinoma and Unresectable HepatoCellular Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment Related Adverse Events (time frame: From beginning of treatment to 30 days post-treatment, approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.