Treatment of Newly Diagnosed Central Malignant Germ Cell Tumor People With Teniposide Injection Combined With Cisplatin.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5+
SponsorChengcheng Guo

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Patients undergoing any other anti-cancer experimental treatment

Individuals with a history of severe allergies or allergies to any component of the drugs in the past

Previous or concurrent active cardiovascular diseases with clinical significance, including congenital heart disease or pericardial disease, history of heart failure, myocardial infarction, coronary heart disease, heart valve disease, cardiomyopathy, and arrhythmia

Patients with Magnetic Resonance Imaging contraindications

Trial design

Treatments tested in this trial

  • Teniposide Injection

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Chengcheng Guo

Lead sponsor

Sun Yat-sen University

Sponsor institution