Prediction of Therapeutic Response of Apatinib in Recurrent Gliomas

STATUS

Recruiting
End date

Jun 1, 2025
participants needed

600
sponsor

The First Affiliated Hospital of Zhengzhou University

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Updated on 19 February 2024

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platelet count

metastasis

neutrophil count

growth factor

liver metastasis

hypertension

vegf

vascular endothelial growth factor

tyrosine

apatinib

postoperative complication

glioma

vascular endothelial growth factor receptor 2

Summary

Apatinib, also known as YN968D1, is a small-molecule tyrosine kinase inhibitor (TKI) that selectively binds to and inhibits vascular endothelial growth factor receptor 2 (VEGFR-2). This study aims to collect clinical, radiological and histopathology imaging including detailed radiological data, survival data, clinical parameters, molecular pathology and images of HE slices in patients with recurrent gliomas whose are treated with Apatinib, for evaluating the efficacy and safety of Apatinib. Moreover, by leveraging artificial intelligence, this study seeks to construct and refine MR and histopathology imaging based algorithms that are able to predict the responses to Apatinib of patients with recurrent gliomas.

Description

Effective treatment for recurrent gliomas is still challenging. Malignant gliomas are considered to be one of the most angiogenic cancers and are mostly sustained by vascular endothelial growth factor (VEGF) signaling via its endothelial tyrosine kinase receptor VEGF receptor 2 (VEGFR-2). Apatinib, also known as YN968D1, is a small-molecule tyrosine kinase inhibitor (TKI) that selectively binds to and inhibits VEGFR-2. Apatinib has been demonstrated as monotherapy that prolongs OS in patients with gastric cancers after two or more lines of chemotherapy with moderate, reversible, and easily managed adverse effects. This study aims to collect clinical, radiological and histopathology imaging including detailed radiological data, survival data, clinical parameters, molecular pathology and images of HE slices in patients with recurrent gliomas whose are treated with Apatinib, for evaluating the efficacy and safety of Apatinib. Moreover, by leveraging artificial intelligence, this study also seeks to construct and refine MR and histopathology imaging based algorithms that are able to predict the responses to Apatinib of patients with recurrent gliomas. The creation of a registry for patients with recurrent gliomas treated by Apatinib with detailed survival data, radiological data, histopathology image data and with sufficient sample size for artificial intelligence provides opportunities for personalized prediction of responses to Apatinib.

Details

Condition	Recurrent Glioma
Age	18-90 years
Treatment	Apatinib
Clinical Study Identifier	NCT04216550
Sponsor	The First Affiliated Hospital of Zhengzhou University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Adult patients with histologically-confirmed WHO Grade II-IV gliomas which have recurrent or progressive conditions
	With measurable or evaluable disease defined by RANO criteria by MRI scan
	Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of 2
	Life expectancy 3 months
	No evidence of serious cardiopulmonary function damage, postoperative complication and hemorrhage on the baseline
	No history of serious hypertension disease
	Patients have adequate organ function as defined by the following criteria
	Hemoglobin (HGB) 90g/L
	Absolute neutrophil count (ANC) 1.5109/L
	White blood cell (WBC) 3.0109/L
	Platelet count 80109/L
	Alanine aminotransferase(ALT) and Aspartate aminotransferase (AST) of 2.5 upper normal limitation (UNL) or 5 UNL in case of liver metastasis
	Creatinine (Cr) of 1.25 UNL or creatinine clearance(Ccr) > 45 ml/min
	With written informed consent signed voluntarily by patients themselves
Exclusion Criteria
	Patients with age<18 or >90 years
	Pregnant or lactating women
	Inadequately controlled hypertension (defined as systolic blood pressure > 140 and/or diastolic blood pressure > 90 mmHg on antihypertensive medications)
	New York Heart Association (NYHA) Grade II or greater congestive heart failure
	Factors that could have an effect on oral medication
	Abnormal Coagulation (international normalized ratio>1.5, prothrombin time>UNL+4s,activated partial thromboplastin time>1.5 UNL), with tendency of bleeding
	Currently receive thrombolytic and anticoagulation therapy
	History of pneumorrhagia(CTCAE grade 2 ) or other parts hemorrhage(CTCAE grade 3 ) within 4 weeks prior to treatment
	History of artery thrombosis and phlebothrombosis, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, within 6 month prior to treatment
	Medical history of clinically significant thrombosis (bleeding or clotting disorder), excluding warfarin(1mg po qd) and aspirin(80-100mg po qd) for prevention under INR1.5

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Prediction of Therapeutic Response of Apatinib in Recurrent Gliomas