Actively Recruiting
Treatment of Newly Diagnosed Central Malignant Germ Cell Tumor People With Teniposide Injection Combined With Cisplatin.
Led by Chengcheng Guo · Updated on 2025-09-23
40
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Newly Diagnosed Central Malignant Germ Cell Tumor People With Teniposide Injection Combined With Cisplatin.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have at least one measurable lesion defined by RANO criteria
- Initial diagnosis confirmed as central malignant germ cell tumor
- Expected survival of 6 months or more
- Absolute neutrophil count at least 1.0 x 10^9/L
- Platelet count at least 100.0 x 10^9/L
- Aspartate aminotransferase and alanine aminotransferase levels no more than 2.5 times the upper limit of normal
- Total bilirubin no more than 1.5 times the upper limit of normal
- Estimated glomerular filtration rate at least 70 mL/min/1.73 m² or normal serum creatinine
- Women and men with fertility must agree to use effective contraception during the study and for 3 months after last dose
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before treatment
- Willing and able to understand and sign informed consent, with parents/guardians able to consent for children or adolescents
You will not qualify if you...
- Receiving any other experimental anti-cancer treatments
- History of severe allergies to study drugs
- Active significant cardiovascular diseases including congenital heart disease, heart failure, myocardial infarction, coronary heart disease, heart valve disease, cardiomyopathy, or arrhythmia
- Contraindications to MRI
- Need for live virus vaccination during treatment
- Serious complications or underlying diseases
- Poorly controlled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg)
- Uncontrolled systemic bacterial, viral, or fungal infections
- Infection with HIV or syphilis
- Prior organ transplantation
- Pregnancy or breastfeeding
- Other factors deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
C
chengcheng Guo, Doctor of Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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