Using irinotecan liposomes with bevacizumab to treat recurrent glioma

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

This study is testing if a new combination of irinotecan liposomes and bevacizumab can help people with recurrent brain glioma feel better and live longer after their first treatment didn’t work.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Central Hospital of Lishui City (Academic / other)
• Drugs / interventions: bevacizumab, beizumab
• Locations: 1 site (Lishui, Zhejiang)
• Trial ID: NCT06801730 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of irinotecan liposomes combined with bevacizumab for patients with progressive or recurrent brain glioma. It is a single-center, single-arm, prospective study focusing on patients who have experienced progression after first-line therapy. The primary goal is to assess the overall response rate (ORR) during treatment, while also monitoring disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed glioma who have progressed after first-line therapy and have measurable lesions.

Not a fit: Patients who have previously received irinotecan or irinotecan liposomes will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent glioma, potentially improving their outcomes.

How similar studies have performed: While this approach is exploratory, similar studies combining targeted therapies with chemotherapy have shown promise in treating various cancers.

Eligibility criteria

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.

Where this trial is running

Lishui, Zhejiang

• The central Hospital of Lishui City — Lishui, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Zhifeng Tian

Conditions Glioma; Irinotecan liposomes; Bevacizumab; Recurrent