Germ cell tumors (GCTs) are a heterogeneous group of tumors that originate from primordial germ cells (PGCs) during early embryonic development. Primary central nervous system germ cell tumors (CNS GCTs) are a specific intracranial manifestation of germ cell tumors, a group of embryonic-origin malignant tumors. Clinically, CNS GCTs most commonly occur in the pineal region (approximately 50%) and t
Conditions
Interventions
Group of Etoposide:Treated with Etoposide
Group of Teniposide:Treatment with Teniposide
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 or younger. 2. Must have at least one measurable lesion as defined by the RANO criteria. 3. Previously untreated, diagnosed with primary central nervous system germ cell tumors in children (including subtypes such as teratomas, yolk sac tumors, and embryonal carcinomas). 4. Expected survival of >=6 months. 5. Laboratory test results meet the following criteria: (1) Absolute neutrophil count >= 1.0 × 10^9/L; (2) Platelet count >= 100.0 × 10^9/L (not following platelet transfusion); (3) Total bilirubin = 70 mL/min/1.73 m^2 or normal serum creatinine (Cr). 6. Parents or guardians of child or adolescent participants who are willing and able to read, understand, and sign a written informed consent form are capable of understanding, consenting to, and signing the research informed consent form and the applicable child consent form prior to the initiation of any study-related procedures.
Exclusion criteria
Exclusion criteria: 1.Patients receiving any other anticancer trial treatment; 2.Patients with a history of severe allergies, or those allergic to any component of the investigational drug (teniposide, polyoxyethylene castor oil, dimethylacetamide, anhydrous ethanol, benzyl alcohol, and maleic acid), or to carboplatin; 3.Patients with a history of or concurrent clinically significant active cardiovascular disease, including congenital heart disease or pericardial disease, a history of heart failure, myocardial infarction, coronary artery disease, valvular heart disease, cardiomyopathy, or arrhythmias; 4.Patients with contraindications for MRI. 5.Individuals who need to receive live-virus vaccines during treatment. 6.Serious complications and/or underlying conditions, such as gastrointestinal bleeding, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary interstitial fibrosis, renal insufficiency, and diabetes with poor glycemic control (fasting blood glucose levels still =10.0 mmol/L despite standard antidiabetic therapy), etc. 7.Patients with poorly controlled hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg); 8.Patients with uncontrolled active systemic bacterial, viral, or fungal infections. 9.People with HIV or syphilis. 10.Patients who have previously undergone an organ transplant. 11.Women who are pregnant or breastfeeding. 12.Researchers believe there are other factors that make participants unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Results of the first RANO tumor assessment (proportion of patients who achieved complete remission (CR) or partial remission (PR) during treatment); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Safety Analysis;Quality of life scores;Objective response rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactYan-Lai Tang
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed