A Single-center, Single-arm, Open-label Study of the Combination of Teniposide Injection and Cisplatin in the Treatment of Newly Diagnosed Patients With Central Malignant Germ Cell Tumors.
This trial is a prospective single arm intervention study, conducting clinical research on marketed drugs. Adverse drug reactions are controllable and the risk is low, with an estimated total of 40 cases. The main objective is to evaluate the safety and efficacy of teniposide combined with cisplatin in the treatment of newly diagnosed central malignant germ cell tumors, and to conduct drug monitoring on subjects to explore potential biomarkers for predicting therapeutic efficacy. It is expected to ultimately achieve the goal of prolonging the overall survival of patients, while providing more guidance for the screening of the best treatment population and biological predictive markers.
• Must have at least one measurable lesion defined by RANO criteria
• The initial diagnosis has been confirmed as central malignant germ cell tumor
• Expected survival period ≥ 6 months
• Absolute neutrophil ≥1.0×10\^9/L; Platelet ≥100.0×10\^9/L
• Aspertate aminotransferase and alanine aminotransferase ≤2.5×Upper limit of normal
• total bilirubin ≤1.5×Upper limit of normal
• Electronic Case Report of Form≥70mL/min/1.73m\^2
• Estimated glomerular filtration rate ≥ 70 mL/min/1.73 m² or normal serum creatinine (Cr)
• Women and men with fertility must agree to use appropriate contraceptive methods (hormones or barrier therapy or abstinence) during the study period and within 3 months after the last dose; The pregnancy test of female subjects of childbearing age within 7 days before administration must be negative
• Willing and able to read, understand, and sign written informed consent, parents/guardians of child or adolescent subjects have the ability to understand, agree, and sign research informed consent forms and applicable child consent forms before initiating any protocol related procedures