Irinotecan Liposomes Combined With Bevacizumab in the Treatment of Recurrent Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06801730
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Zhifeng Tian,MD
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Zhifeng Tian
Principal Investigator Affiliation	The Central Hospital of Lishui City
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Irinotecan liposome combined with bevacizumab

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

Interventions

Drug: - Irinotecan liposome combined with bevacizumab

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

Contact a Trial Team

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International Sites

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

Status

Recruiting

Address

The central Hospital of Lishui City

Lishui, Zhejiang, 323000

Site Contact

Zhifeng Tian

[email protected]

0086-13515789419

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