NCT07188441

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

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chengcheng Guo · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• GCT
• Germ Cell Tumor
• Central Malignant Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	Teniposide Injection	teniposide 300mg/m2 for 5 days, cisplatin 75mg/m2 for 5 days

Timeline

• Start date: 2024-08-13
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-09-23
• Last updated: 2025-09-23

Locations

1 site across 1 country: China