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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.
The subjects received an injection of teniposide combined with cisplatin every 3 weeks for one cycle. The teniposide dosage was 300 mg/m2, administered continuously over 3 to 5 days, each time with 500 ml of normal saline through intravenous drip; the cisplatin dosage was 75 mg/m2, also administered continuously over 3 to 5 days, for a total of 4-6 cycles. Radiation therapy was conducted according to standard practices after chemotherapy.
Age
5 - No limit years
Sex
ALL
Healthy Volunteers
No
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Start Date
August 13, 2024
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2026
Last Updated
September 23, 2025
40
ESTIMATED participants
Teniposide Injection
DRUG
Lead Sponsor
Chengcheng Guo
NCT03067181
NCT07218913
Data Source & Attribution
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