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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Teniposide Injection
Drugteniposide 300mg/m2 for 5 days, cisplatin 75mg/m2 for 5 days
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Teniposide plus cisplatinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate(ORR)
The proportion of patients who achieved complete response (CR) or partial response (PR) ( i.e. CR PR) from the first use of the investigational drug to the period of withdrawal from the trial, compared to the total number of evaluable cases.
Time frame
3 weeks.Sponsors and contacts
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Chengcheng Guo
Lead sponsor
Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov