Clinical trial NCT03384511: The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
Official title: Whether 18F-ALF-NOTA-PRGD2 PET/CT Scan Can Predict the Efficacy and Adverse Events of Apatinib in Patients With Malignancies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malignancies
Stomach Cancer
Non-small Cell Lung Cancer
Esophageal Cancer
Breast Cancer
Ovary Cancer
Cervical Cancer
Keywords: RGD PET-CT
Apatinib
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Apatinib at oral dose of 250 mg twice daily (500 mg/day) for a minimum of 30 days
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor response defined by RECIST criteria
timeFrame: At 1 month of the study
Secondary outcomes:
measure: Days from the start of therapy to disease progression or death due to any cause
timeFrame: At 6 months of the study
measure: Days from the start of therapy to death due to any cause
timeFrame: Up to 12 months
measure: Treatment-Related Adverse Events as Assessed by CTCAE
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Jinan
country: China
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Shuanghu Yuan, MD;PhD
role: PRINCIPAL_INVESTIGATOR
References: