Phase I Clinical Study of Oral TG02 Capsule in the Treatment of Recurrent / Progressive High-grade Glioma Patients

Exclusion Criteria

• •1. Other cytotoxic drugs were received within 28 days prior to the start of the study, or adverse reactions from previous systematic treatment have not recovered (except alopecia and pigmentation).
• •2. Bevacizumab was treated within 6 weeks before the start of the study.
• •3. Previous treatment with carmostine sustained-release implants or intracerebral implantation of radiotherapy.
• •4. A patient with a major seizure that cannot be effectively controlled by drugs.
• •5. MRI examinations cannot be performed (e.g. pacemakers, undesirable metal dentures, etc.).
• •6. Patients with severe impairment of liver and kidney function: ALT ≥ 2.5 ULN,AST ≥ 2.5 ULN in patients without liver metastasis; ALT ≥ 5 ULN,AST ≥ 5 ULN in patients with liver metastasis; Or TBIL ≥ 1.5 ULN, or Cr ≥ 1.5 ULN, or creatinine clearance ≤ 60 ml/ min calculated by Cockcroft-Gault formula;
• •7. Unstable or uncontrollable diseases or conditions related to or affecting cardiac function (e.g. unstable angina pectoris, congestive heart failure \[NYHA \> II\], uncontrolled hypertension \[diastolic blood pressure \> 85 mmHg; systolic blood pressure \>145 mmHg\]), arrhythmia or prolonged QTc interval (male \> 450 Ms; female \> 470ms).
• •8. A history of arterial thromboembolism (such as stroke, transient ischemic attack, or myocardial infarction) within 6 months. Bleeding or hypercoagulable coagulation disorder occurred within 6 months prior to the first day of the study.
• •9. Active peptic ulcer or inflammatory bowel disease.
• •10. Active hepatitis, or HIV, Treponema pallidum infection.
• •11. Pregnant or breastfeeding.
• •12. Subjects who were unable to use adequate contraception during the study and for six months after the end of the study were unable to use adequate contraception.
• •13. Currently participating in another clinical trial or within 30 days of the last administration of the trial drug.
• •14. The subjects had conditions that affected their provision of written informed consent and / or compliance with the research process.
• •15. There were cases in which any other investigator did not consider it appropriate to join the group.