Predicting how well Apatinib works for patients with recurrent gliomas
MR and Histopathology Images Based Prediction of Therapeutic Response of Apatinib in Recurrent Gliomas Using Artificial Intelligence
This study is testing how well Apatinib works for people with recurring gliomas and using advanced technology to predict their responses to the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Zhengzhou University Academic / other |
| Drugs / interventions | Apatinib, chemotherapy |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT04216550 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with recurrent gliomas who are treated with Apatinib, a tyrosine kinase inhibitor targeting VEGFR-2. It aims to collect various clinical, radiological, and histopathological data to evaluate the efficacy and safety of Apatinib. Additionally, the study will utilize artificial intelligence to develop algorithms that predict patient responses to the treatment based on imaging and pathology data. The creation of a comprehensive registry will facilitate personalized treatment approaches for glioma patients.
Who should consider this trial
Good fit: Ideal candidates include adult patients with histologically-confirmed recurrent or progressive WHO Grade II-IV gliomas who meet specific health criteria.
Not a fit: Patients with serious cardiopulmonary issues, uncontrolled hypertension, or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment strategies for patients with recurrent gliomas.
How similar studies have performed: While the use of Apatinib has shown promise in other cancers, this specific approach utilizing AI for predicting responses in gliomas is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Zhengzhou, Henan
- Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Zhenyu Zhang, Dr.
- Email: fcczhangzy1@zzu.edu.cn
- Phone: +86 17839973727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.