Irinotecan Liposomes Combined With Bevacizumab in the Treatment of Recurrent Glioma

Phase 2

Recruiting

• Conditions: Glioma
• Interventions: Drug: Irinotecan liposome combined with bevacizumab

• Registration Number: NCT06801730
• Lead Sponsor: Zhifeng Tian,MD

Brief Summary

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.

Detailed Description

This study was to observe the efficacy and safety of irinotecan liposomes combined with bevacizumab in the treatment of progressive/recurrent brain glioma. The study was a single-center, single-arm, prospective study. Patients with progressive/recurrent glioma who met the inclusion criteria and did not meet the exclusion criteria were treated with irinotecan liposome combined with beizumab. The optimal ORR of patients during treatment was mainly evaluated, and the DCR, DoR, PFS, OS, and safety of patients were mainly evaluated.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-08
• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-24
• Last Update Submitted: 2025-01-24
• Study First Posted: 2025-01-30
• Last Update Posted: 2025-01-30
• Primary Completion: 2026-12-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Irinotecan liposome combined with bevacizumab	Irinotecan liposome combined with bevacizumab	Irinotecan liposomes, 50mg/m2, d1, 90 min intravenously, Q2W; Bevacizumab 10mg/kg, d1, Q2W;

Primary Outcome Measures

Name	Time	Method
Objective response rate	From date of randomization until the date of one year	The proportion of patients with optimal tumor response, complete response (CR) or partial response (PR) assessed based on the RECIST v1.1 criteria

Secondary Outcome Measures

Name	Time	Method
Overall survival	From date of randomization until the date of death from any cause, assessed up to 24 months	The time between the start of treatment and the first recorded death
Progression free survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months	The time from the start of treatment to the first recording of PD or death, whichever occurs first

Trial Locations

Locations (1)

The central Hospital of Lishui City; 🇨🇳 Lishui, Zhejiang, China