Clinical trial · Interventional
Irinotecan Liposomes Combined With Bevacizumab in the Treatment of Recurrent Glioma
Exploratory Study of Irinotecan Liposomes Combined With Bevacizumab in the Treatment of Progressive or Recurrent Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
With the optimization of the dosage form of irinotecan, the replacement of ordinary irinotecan with irinotecan liposomes should improve the safety and the expected efficacy. Therefore, an exploratory study on the treatment progress of irinotecan liposomes combined with bevacizumab for recurrent brain glioma should be conducted. To evaluate the efficacy and safety of irinotecan liposomes combined with bevacizumab in the treatment of progressive/recurrent brain glioma, so as to provide more treatment options for patients with brain glioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan liposome combined with bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Irinotecan liposome combined with bevacizumab
- description
- Irinotecan liposomes, 50mg/m2, d1, 90 min intravenously, Q2W; Bevacizumab 10mg/kg, d1, Q2W;
- interventionNames
- Drug: Irinotecan liposome combined with bevacizumab
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- From date of randomization until the date of one year
- description
- The proportion of patients with optimal tumor response, complete response (CR) or partial response (PR) assessed based on the RECIST v1.1 criteria
Secondary outcomes (2)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-75 years old; * Patients diagnosed with glioma by histology, patients with progress in first-line therapy, including postoperative recurrence, progress in first-line standard therapy, and patients unable to undergo surgery/radiotherapy; * no previous treatment with irinotecan or irinotecan liposomes; * At least one measurable or evaluable lesion according to RANO criteria; * ECOG score is 0\~1; * Good bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L, white blood cells (WBC) ≥3.0×109/L, albumin (ALB) ≥32 g/L, and no bleeding tendency; ② AST, ALT and alkaline phosphatase (ALP) were all ≤2.5× upper limit of normal range (ULN), and ≤5×ULN when liver metastases occurred; Total bilirubin ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 ml/min (calculated according to Cockroft-Gault); * Expected survival ≥3 months; * Can understand the situation of this study, patients and (or) legal representatives voluntarily agree to participate in this study and sign informed consen; Exclusion Criteria: * Patients allergic to the investigational drug and its excipients; * Known or suspected central nervous system metastasis; * The use of potent depressants or inducers of CYP3A, CYP2C8, and UGT1A1 (anticonvulsants \[phenytoin, phenobarbital, or carbamazepine\], rifampicin, rifambutin, St.John's.) could not be discontinued or were not discontinued within 2 weeks prior to enrollment Wort\], grapefruit juice, clarithromycin, itraconazole, Lopinavir, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Terrapivir, voriconazole, Azanavir, Gefilozil, indinavir, etc.); * There are signs and symptoms of intestinal obstruction; * have had other malignant tumors within the past 5 years or currently, except for cured cervical carcinoma in situ, uterine carcinoma in situ and non-melanoma skin cancer; * Pregnant or lactating female patients, patients of childbearing age who refuse to accept contraceptive measures; * Patients considered by the investigator to be unsuitable for this study.
References
Publications (0)
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