Using irinotecan liposomes with bevacizumab to treat recurrent glioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The central Hospital of Lishui City
  Lishui, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Zhifeng Tian
• Email: tzf419@hotmail.com
• Phone: 0086-13515789419

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.