Breast Cancer, Cervical Cancer, Esophageal Cancer, Malignancies, Non-small Cell Lung Cancer, Ovary Cancer, Stomach Cancer
Conditions
Keywords
RGD PET-CT, Apatinib
Brief summary
This is an open-label, single arm study to explore whether 18F-ALF-NOTA-PRGD2 PET/CT scan can predict the efficacy and adverse events of apatinib in patients with malignancies. Integrin αvβ3 has been shown to play an important role in angiogenesis and up-regulated obviously in various types of tumor cells and activated endothelial cells. The arginine-glycine-aspartic acid (RGD) tripeptide sequence can bind to integrin αvβ3 with high affinity and specificity. The 18F-ALF-NOTA-PRGD2 will highly combine with αvβ3, and thus will monitor the antiangiogenic status.In the current study, investigators propose to evaluate the feasibility of 18F-RGD PET/CT in monitoring efficacy and adverse events of apatinib in malignancies.
Detailed description
This is an open-label, single arm study to explore whether 18F-ALF-NOTA-PRGD2 positron emission tomography/computed tomography (18F-RGD PET/CT) scan can predict the efficacy and adverse events of apatinib in patients with malignancies. Angiogenesis, the formation of new blood vessels, is the process of generating neovascularization from preexisting vessels. It can promote tumor growth and metastasis by providing nutrients and oxygen. Integrin αvβ3 has been shown to play an important role in angiogenesis and up-regulated obviously in various types of tumor cells and activated endothelial cells. Since the arginine-glycine-aspartic acid (RGD) tripeptide sequence can bind to integrin αvβ3 with high affinity and specificity, RGD PET/CT may be helpful to evaluate the biological and metabolic activity status during angiogenesis. However, 18F-ALF-NOTA-PRGD2 PET/CT as response biomarker for antiangiogenic therapy has not been fully proved and is still without universal understanding according to current publications. Apatinib (YN968D1) is the first orally antiangiogenic drug targeting VEGFR-2 tyrosine kinase.In the current study, investigators propose to evaluate the feasibility of 18F-RGD PET/CT in monitoring efficacy and adverse events of apatinib in malignancies. Patients confirmed malignancies histopathologically will be prospectively enrolled in the study. All patients provided written informed consent prior to enrollment. Patients will receive apatinib therapy, and undergo 18F-RGD PET/CT scans berore and after first cycle of therapy.
Interventions
DRUGApatinib
Patients will accept apatinib therapy and undergo baseline 18F-ALF-NOTA-PRGD2 PET/CT scans of the whole body after having met all eligibility criterias.
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Apatinib at oral dose of 250 mg twice daily (500 mg/day) for a minimum of 30 days
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of malignancies * Scheduled for second- or third-line apatinib therapy * Karnofsky performance status (KPS) ≥70 * Measurable primary tumors according to Response Evaluation Criteria in Solid Tumors (RECIST)
Exclusion criteria
* Active infection, myocardial infarction within 6 months, symptoms of heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive therapy * The claustrophobic patients and patients with implanted metal objects * The pregnancy * Inability to complete the required examinations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response defined by RECIST criteria | At 1 month of the study | Tumor response will be evaluated as complete response or partial response or stable disease or PD according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days from the start of therapy to disease progression or death due to any cause | At 6 months of the study | Progression free survival (evaluated by RECIST criteria), defined as the interval from start of therapy to investigator-assessed progression or death due to any cause, whichever occurs first or lost of follow-up. |
| Days from the start of therapy to death due to any cause | Up to 12 months | Overall survival is the time interval from the start of therapy to death due to any reason or lost of follow-up. |
| Treatment-Related Adverse Events as Assessed by CTCAE | Through study completion, an average of 6 months | Common Terminology Criteria for Adverse Events （CTCAE） |
Countries
China
Outcome results
None listed