Irinotecan Liposomes Combined With Bevacizumab in the Treatment of Recurrent Glioma (NALIRIBVRG)

January 24, 2025 updated by: Zhifeng Tian,MD

Exploratory Study of Irinotecan Liposomes Combined With Bevacizumab in the Treatment of Progressive or Recurrent Glioma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Lishui, Zhejiang, China, 323000
        • Recruiting
        • The Central Hospital of Lishui City
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Irinotecan liposome combined with bevacizumab
Irinotecan liposomes, 50mg/m2, d1, 90 min intravenously, Q2W; Bevacizumab 10mg/kg, d1, Q2W;
Drug: Irinotecan liposome combined with bevacizumab
Irinotecan liposomes, 50mg/m2, d1, 90 min intravenously, Q2W; Bevacizumab 10mg/kg, d1, Q2W;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 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
From date of randomization until the date of one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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
From date of randomization until the date of death from any cause, assessed up to 24 months
Progression free survival
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhifeng Tian,MD

Investigators

  • Study Chair: Zhifeng Tian, The Central Hospital of Lishui City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2025

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 24, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024(I)-107-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

At the end of the test, the decision is made according to the test results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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