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Irinotecan Liposomes Combined With Bevacizumab in the Treatment of Recurrent Glioma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06801730•Zhifeng Tian,MD

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

The central Hospital of Lishui City

Lishui, Zhejiang, China

Key Dates

Start Date

January 8, 2025

Primary Completion Date

December 15, 2026

Completion Date

December 15, 2026

Last Updated

January 30, 2025

Enrollment

ESTIMATED participants

Conditions

Glioma

Interventions

Irinotecan liposome combined with bevacizumab

DRUG

Contacts

Zhifeng Tian

CONTACT

0086-13515789419 tzf419@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Irinotecan Liposomes Combined With Bevacizumab in the Treatment of Recurrent Glioma

Inclusion Criteria

Exclusion Criteria

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

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