Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prediction of Therapeutic Response of Apatinib in Recurrent Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216550
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Zhenyu Zhang, The First Affiliated Hospital of Zhengzhou University

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.

Condition or disease Intervention/treatment
Recurrent Glioma Drug: Apatinib

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 36 Months
Official Title: MR and Histopathology Images Based Prediction of Therapeutic Response of Apatinib in Recurrent Gliomas Using Artificial Intelligence
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Apatinib
Apatinib 0.5g orally daily until the untolerable toxicities, disease progression or death
Drug: Apatinib
Apatinib 0.5g orally daily until the untolerable toxicities, disease progression or death




Primary Outcome Measures :
  1. Changes of Response to Treatment [ Time Frame: From enrollment to progression of disease. Estimated about 6 months ]
    Response were evaluated with Response Assessment in Neuro-Oncology (RANO) criteria every 1 month after treament.


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: From enrollment to progression of disease. Estimated about 6 months. ]
    The length of time from enrollment until the time of progression of disease (PFS, progression-free survival)

  2. Overall Survival (OS) [ Time Frame: From enrollment to death of patients. Estimated about 1 year. ]
    The length of time from enrollment until the time of death (OS, overall survival)

  3. Incidence of treatment-related adverse events [ Time Frame: Time Frame: 0 to 1 year ]
    The incidence of treatment-related adverse events were graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.


Biospecimen Retention:   Samples With DNA
All participants have signed the informed consent. Fresh frozen tissues of participants are collected immediately after tumor resection and preserved in liquid nitrogen. Whole exome sequencing, RNA sequencing and proteomics are planed to be conducted.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects are all received anti-angiogenesis drug (Apatinib) in the First Affiliated Hospital of Zhengzhou University.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216550


Contacts
Layout table for location contacts
Contact: Zhenyu Zhang, Dr. +86 17839973727 fcczhangzy1@zzu.edu.cn

Locations
Layout table for location information
China, Henan
Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Zhenyu Zhang, Dr.    +86 17839973727    fcczhangzy1@zzu.edu.cn   
Sponsors and Collaborators
The First Affiliated Hospital of Zhengzhou University
Layout table for additonal information
Responsible Party: Zhenyu Zhang, Principal Investigator, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT04216550    
Other Study ID Numbers: GliomaAI-5
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhenyu Zhang, The First Affiliated Hospital of Zhengzhou University:
Therapeutic responses
Radiological
Histopathology Imaging
Artificial intelligence
Apatinib
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action