Prediction of Therapeutic Response of Apatinib in Recurrent Gliomas

NCT ID: NCT04216550

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2025-06-01

Brief 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.

Detailed 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.

Conditions

Recurrent Glioma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Apatinib

Apatinib 0.5g orally daily until the untolerable toxicities, disease progression or death

Apatinib

Intervention Type: DRUG

Apatinib 0.5g orally daily until the untolerable toxicities, disease progression or death

Interventions

Apatinib

Apatinib 0.5g orally daily until the untolerable toxicities, disease progression or death

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adult patients with histologically-confirmed WHO Grade II-IV gliomas which have recurrent or progressive conditions.

2. With measurable or evaluable disease defined by RANO criteria by MRI scan.

3. Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2

4. Life expectancy ≥3 months.

5. No evidence of serious cardiopulmonary function damage, postoperative complication and hemorrhage on the baseline.

6. No history of serious hypertension disease.

7. Patients have adequate organ function as defined by the following criteria:

• Hemoglobin (HGB) ≥90g/L
• Absolute neutrophil count (ANC) ≥1.5×109/L
• White blood cell (WBC) ≥3.0×109/L
• Platelet count ≥80×109/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.

8. With written informed consent signed voluntarily by patients themselves.

Exclusion Criteria

1. Patients with age<18 or >90 years.

2. Pregnant or lactating women.

3. Inadequately controlled hypertension (defined as systolic blood pressure > 140 and/or diastolic blood pressure > 90 mmHg on antihypertensive medications).

4. New York Heart Association (NYHA) Grade II or greater congestive heart failure.

5. Factors that could have an effect on oral medication.

6. Abnormal Coagulation (international normalized ratio>1.5, prothrombin time>UNL+4s,activated partial thromboplastin time>1.5 UNL), with tendency of bleeding.

7. Currently receive thrombolytic and anticoagulation therapy

8. History of pneumorrhagia(CTCAE grade ≥2 ) or other parts hemorrhage(CTCAE grade ≥3 ) within 4 weeks prior to treatment.

9. 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.

10. Medical history of clinically significant thrombosis (bleeding or clotting disorder), excluding warfarin(1mg po qd) and aspirin(80-100mg po qd) for prevention under INR≤1.5.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: lead

Responsible Party

Zhenyu Zhang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhenyu Zhang, Dr.

Role: CONTACT

fcczhangzy1@zzu.edu.cn

+86 17839973727

Facility Contacts

Zhenyu Zhang, Dr.

Role: primary

fcczhangzy1@zzu.edu.cn

+86 17839973727

Other Identifiers

GliomaAI-5

Identifier Type: -

Identifier Source: org_study_id