Glioma
Conditions
Interventions
Treatment group:Irinotecan liposomal cisplatin bevacizumab, repeated every 4 weeks until disease progression or intolerable toxicity. Imaging (MRI) is recommended every 2-3 cycles of treatment.
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~75 years old; 2. Patients with recurrent high-grade (WHO grade IV) glioma confirmed by histopathology, cytopathology or imaging; 3. If chemotherapy has been received, the toxicity has recovered to =4 weeks from the last chemotherapy; 4. ECOG 0-2 points; 5. Expected survival time>=3 months; 6. Presence of at least one measurable target lesion according to RANO criteria; 7. Bone marrow function: absolute neutrophil count (ANC) >=1.5×10^9/L, hemoglobin >=90g/dL, platelets (PLT) >=100×10^9/L, white blood cells (WBC) >=3.0×10^9/L; 8. Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) = 60 mL/min (according to the Cockcroft-Gault formula); 10. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) <=1.5×ULN; 11. Patients with biliary obstruction or no evidence of ongoing infection should receive adequate biliary drainage; No active or suspected infection is allowed; 12. Non-pregnant or lactating females; Females/males of childbearing potential should use effective contraception during the study and for 6 months after the end of study treatment; 13. Patient compliance is good, can understand the study process of this study, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.History of other malignancies within the past 5 years (except adequately treated carcinoma in situ or basal cell skin carcinoma) 2.Factors significantly affecting oral drug absorption (e.g., dysphagia, chronic diarrhea, intestinal obstruction) 3.Clinically significant bleeding symptoms/hemorrhagic tendency within 3 months prior to treatment: Blood loss >30 mL with hematemesis, melena, or hematochezia; Hemoptysis (>5 mL fresh blood within 4 weeks) 4.Concomitant use of: Strong CYP3A4 inducers within 3 weeks or Strong CYP3A4/UGT1A1 inhibitors within 3 weeks before first dose 5.Active cardiac disease within 6 months prior to treatment: Myocardial infarction; Severe/unstable angina; LVEF =160 mmHg and/or DBP >=100 mmHg) despite antihypertensive medications 7.Active infection or unexplained fever >38.5°C during screening except tumor-related fever per investigator's judgment 8.Immunodeficiency conditions: Active hepatitis (ALT/AST exceeding inclusion criteria): HBV DNA >=1000 IU/mL (hepatitis B); HCV RNA >=1000 IU/mL (hepatitis C); Chronic HBV carriers (HBV DNA 1 diarrhea with: 4 daily bowel movements vs baseline; Significant ostomy output increase; ADL limitations; Life-threatening complications requiring urgent intervention 11.Participation in other clinical trials within 4 weeks prior to enrollment 12.Other exclusion criteria determined by investigator's discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival;Quality of life score; | — |
Countries
China
Contacts
Public ContactJiang Xin
The First Hospital of Jilin University
Outcome results
None listed