Recurrent high-grade glioma
Conditions
Interventions
Experimental group:Irinotecan liposome combined with bevacizumab and concurrent radiotherapy
Sponsors
Anqing Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age > 18 years; 2. Patients with histologically and/or cytologically confirmed recurrent high-grade (WHO Grade III-IV) glioma; 3. If chemotherapy was administered, >=4 weeks since last chemotherapy cycle with toxicity recovery to =3 months; 5. Tumor progression following first-line therapy as determined by the clinician; 6. Bone marrow function: Absolute neutrophil count (ANC) >= 1.5 × 10?/L, hemoglobin >= 90 g/dL, platelets (PLT) >= 100 × 10?/L, white blood cells (WBC) >= 3.0 × 10?/L; 7. Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) = 60 mL/min (calculated using Cockcroft-Gault formula); 9. Coagulation function: Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) <=1.5 × ULN; 10. Patients with biliary obstruction or no evidence of persistent infection must undergo adequate biliary drainage; active or suspected infection is not permitted; 11. Non-pregnant and non-lactating females; effective contraception must be used by females of childbearing potential and males during the study and for 6 months after study treatment completion; 12. Patients must demonstrate good compliance, understand the study protocol, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Significant clinical bleeding symptoms or marked bleeding tendency within 3 months prior to treatment (bleeding > 30 mL within 3 months, presenting with hematemesis, melena, or bloody stools); hemoptysis (fresh blood > 5 mL within 4 weeks); 2. Concurrent use of potent CYP3A4 inducers within 3 weeks prior to first dose, or concurrent use of potent CYP3A4 inhibitors or potent UGT1A1 inhibitors within 3 weeks prior to first dose; 3. Active cardiac disease within 6 months prior to treatment, including myocardial infarction, severe/unstable angina pectoris. Echocardiography showing left ventricular ejection fraction =160 mmHg and/or diastolic blood pressure >=100 mmHg); 5. Active infection or unexplained fever >38.5°C during screening or prior to first dosing (tumor-related fever may be acceptable at investigator discretion); 6. Congenital or acquired immunodeficiency (e.g., stable HBV infection: HBV DNA >=1000 IU/mL; stable HCV infection: HCV RNA >=1000 IU/mL); Chronic hepatitis B virus carriers with HBV DNA < 2000 IU/ml may be included only if concurrent antiviral therapy is administered throughout the study period; 7. Any other disease, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the investigator's judgment, raises reasonable suspicion of a condition or disease rendering the subject unsuitable for study drug administration, potentially affecting study result interpretation, or placing the subject at high risk; 8. Severe increase in stoma output; limitation in instrument-assisted activities of daily living (IADL) or even self-care activities of daily living (ADL); life-threatening condition; requiring urgent treatment; 9. Patients deemed unsuitable for trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Overall Survival, OS;Duration of relief, DOR;Progression free survival, PFS; | — |
Countries
China
Contacts
Public ContactLi Chenghui
Anqing Municipal Hospital
Outcome results
None listed