A Prospective, Single-arm Clinical Study on the Safety and Efficacy of Ivoximab Combined With Temozolomide in the Treatment of Relapsed/Refractory Glioma
This study is a prospective, single-arm clinical trial aimed at evaluating the safety and efficacy of ivoximab combined with temozolomide in the treatment of relapsed/refractory glioma. The study plans to enroll 29 patients with relapsed/refractory glioma. After signing informed consent and meeting the inclusion/exclusion criteria through screening, patients will receive treatment with ivoximab combined with temozolomide. Efficacy evaluation will be conducted every two treatment cycles using the Response Assessment in Neuro-Oncology (RANO 2.0) criteria, and treatment will continue until disease progression or intolerance to the combined regimen.
• Relapsed/refractory glioma confirmed by histology and clinical imaging; ECOG performance status score of 0-1; Expected survival time ≥ 6 months; Adequate organ function, as demonstrated by meeting the following laboratory parameters; For female subjects of childbearing potential, a urine or serum pregnancy test must be performed within 3 days prior to the first dose of study drug (Cycle 1, Day 1), and the result must be negative. If the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required. A female of non-childbearing potential is defined as being postmenopausal for at least one year, or having undergone surgical sterilization or hysterectomy； If there is a risk of pregnancy, all subjects (both male and female) must use contraceptive measures with a failure rate of less than 1% per year throughout the entire treatment period until 120 days after the last dose of the study drug (or 180 days after the last dose of chemotherapy).