A Phase 2 interventional study of Teniposide Injection in GCT, Germ Cell Tumor and Central Malignant Germ Cell Tumor, sponsored by Chengcheng Guo. Recruiting at 1 site in China. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Chengcheng Guo · Phase 2, Interventional, and Treatment
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.
291 studies on the registry are indexed under Neoplasms, Germ Cell and Embryonal; 51 are open to participants now.
This study's planned enrollment of 40 is close to the median of 37 across 211 interventional studies indexed under Neoplasms, Germ Cell and Embryonal.
Browse Neoplasms, Germ Cell and Embryonal studies →Chengcheng Guo is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Our study set up only one experimental group without a control group, and all subjects received the same intervention, namely the combination of Teniposide injection and Cisplatin for the treatment of newly diagnosed central malignant germ cell tumor patients. The effectiveness was assessed by observing the results and comparing them with historical data.
Drug: Teniposide Injection
teniposide 300mg/m2 for 5 days, cisplatin 75mg/m2 for 5 days
Also known as: cisplatin
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.
Plan to share: No
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Neoplasms, Germ Cell and Embryonal→
Chengcheng Guo