recurrent high-grade glioma
Conditions
Interventions
experimental group:bevacizumab 5mg/kg ivgtt d1
temozolomide 100mg/m2 po d1-7
nanoliposomal irinotecan 50mg/m2 ivgtt d1
Sponsors
Shandong Cancer Hospital Affiliated of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Understand and be willing to sign written informed consent and be able to follow research protocols for treatment. (2) Age =18 years old and =75 years old. (3) Recurrent high-grade glioma subjects confirmed by histopathology or cytology and treated with standard treatment such as surgery, radiotherapy and / or chemotherapy ( according to the 2021 WHO classification of central nervous system tumors, and CNSWHO grade 3 and 4, confirmed by imaging evaluation as progress or recurrence ). (4) The toxicity of previous anti-tumor therapy must be restored to CTCAE V5.0 grade 1 or below except for alopecia. (5) If corticosteroids are used, the dose must be stable for at least 3 days before determining baseline imaging. ( The total daily dose of dexamethasone = 5mg is considered to be stable, and other corticosteroids are converted according to the equivalent dose of dexamethasone ). (6) According to the RANO standard, there is at least one assessable lesion. (7) ECOG performance status of 0-1. (8) Predicted survival time = 3 months. (9) Adequate organ function according to the following laboratory test values: a. Absolute neutrophil count ( ANC ) = 1.5 × 10^9 / L b. Hemoglobin ( Hb ) = 90g / L c. Platelet count ( PLT ) = 100 × 10^9 / L d. Total bilirubin ( TBIL ) = 1× ULN. e. spartate aminotransferase ( AST ) = 2.5 × ULN. Alanine aminotransferase ( ALT ) = 2.5 × ULN (AST and ALT =5×ULN in patients with liver metastasis) f. serum creatinine=1.2mg/dL,and Creatinine clearance rate = 50mL / min ( calculated according to the Cockcroft-Gault formula ) (10) LVEF=50% (11) Women who are not pregnant or lactating. During the study period and within 6 months of the end of the study treatment, childbearing age Women/men should take effective contraceptive measures.
Exclusion criteria
Exclusion criteria: (1) patients with other malignant tumors within the previous 5 years, except for cure carcinoma in situ, skin basal cell carcinoma. (2) Previous history of severe allergies, or allergies to any component of the test drug (temozolomide and nanoliposomal irinotecan) (3) Pulmonary fibrosis or interstitial pneumonia was diagnosed within 28 days before enrollment. (4) Patients with active hepatitis B, hepatitis C, syphilis (5) Patients with severe cardiac dysfunction within 6 months before enrollment, such as unstable angina, myocardial infarction, heart failure (New York Heart Association functional class >II) (6) Patients inability to take oral medication or lack of absorption of gastrointestinal tract (7) Uncontrolled hypertension by antihypertensive medication (systolic blood pressure >150 mmHg or diastolic pressure >100 mmHg). (8) Received strong inhibitors or inducers of CYP3A4 and CYP2C8, or UGT1A1. (9) Prolonged chronic diarrhea (10) There were seizures that could not be controlled by drugs (11) History of a definite mental disorder. (12) Patients who have participated in other clinical trials in the past 4 weeks. (13) The researchers believe that there are other factors that are not suitable for the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;Disease Control Rate, DCR;Overall Survival, OS;safety; | — |
Countries
China
Contacts
Public ContactTingyong Fan/Xiuping Ding
Cancer Hospital Affiliated of Shandong First Medical University
Outcome results
None listed