Irinotecan Liposomes Combined With Bevacizumab in the Treatment of Recurrent Glioma

NCT06801730 | Recruiting Phase 2

• 1 other identifier: 2024(I)-107-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Keywords

Irinotecan liposomes; Bevacizumab; Recurrent; Glioma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  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 Outcomes (2)

• 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

• Overall survival

  From date of randomization until the date of death from any cause, assessed up to 24 months

Study Arms (1)

Irinotecan liposome combined with bevacizumab

EXPERIMENTAL

Irinotecan liposomes, 50mg/m2, d1, 90 min intravenously, Q2W; Bevacizumab 10mg/kg, d1, Q2W;

Drug: Irinotecan liposome combined with bevacizumab

Interventions

Irinotecan liposome combined with bevacizumab DRUG

Irinotecan liposomes, 50mg/m2, d1, 90 min intravenously, Q2W; Bevacizumab 10mg/kg, d1, Q2W;

Irinotecan liposome combined with bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhifeng Tian,MD: lead

Study Sites (1)

The central Hospital of Lishui City

Lishui, Zhejiang, 323000, China

RECRUITING

MeSH Terms

Conditions

Glioma; Recurrence

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Zhifeng Tian

  The Central Hospital of Lishui City

  STUDY CHAIR

Central Study Contacts

Zhifeng Tian

CONTACT

0086-13515789419; tzf419@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head and neck esophageal Center

Model Details: Single-arm prospective exploratory study

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: January 8, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

CN (1)