Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT02848794
Eligibility Criteria:
Inclusion Criteria:
1. Patients with histologically-confirmed, high-grade glioma(WHO Ⅲ/Ⅳ) who have progressed on temozolomide, or radiotherapy alone, or combined with chemotherapy within 3 months after surgery .
2. With measurable or evaluable disease defined by RECIST 1.1 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 cerebral embolism, cerebral hemorrhage and serious hypertension disease.
7. Recovery from the effects of prior therapy, including the following: 4 weeks from cytotoxic agents (except 6 weeks from nitrosoureas and mitomycin), radiotherapy and surgery.
8. 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.
9. Patients will take contraceptive measures for the duration of the treatments and 8 weeks after the last treatment.
10. With written informed consent signed voluntarily by patients themselves.
Exclusion Criteria:
1. Pregnant or lactating women.
2. Inadequately controlled hypertension (defined as systolic blood pressure \> 140 and/or diastolic blood pressure \> 90 mmHg on antihypertensive medications).
3. New York Heart Association (NYHA) Grade II or greater congestive heart failure.
4. Coronary heart disease greater than ClassⅠ;Ⅰ-level arrhythmia (including QT interval prolongation≥440 ms) together with ClassⅠcardiac dysfunction
5. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction).
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
75 Years
Study:
NCT02848794
Study Brief:
Protocol Section:
NCT02848794