NCT07188441RecruitingPhase 2
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.
Source: ClinicalTrials.gov · Last updated 23 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 23 Jul 2024
- Start date
- 13 Aug 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Chengcheng Guo
- Diseases
- Childhood cancers
- NCT number
- NCT07188441
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 13 Aug 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Those who need to receive live virus vaccine during administration
- Patients who have undergone organ transplantation in the past
Other illness
- 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
- Serious complications and/or underlying diseases
- Individuals with poor control of hypertension (under standardized blood pressure reduction protocols, systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg)
- Uncontrolled systemic bacterial, viral, or fungal infections
- Patients infected with Human Immunodeficiency Virus(HIV) or syphilis
Other
- Patients with Magnetic Resonance Imaging contraindications
- Pregnant or lactating women
- Researchers believe that there are other factors that are not suitable for participating in the experiment
Who the study is looking for
- 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
- Aspertate aminotransferase and alanine aminotransferase ≤2.5×Upper limit of normal
- total bilirubin ≤1.5×Upper limit of normal
- Electronic Case Report of Form≥70mL/min/1.73m\^2
- Estimated glomerular filtration rate ≥ 70 mL/min/1.73 m² or normal serum creatinine (Cr)
- Women and men with fertility must agree to use appropriate contraceptive methods (hormones or barrier therapy or abstinence) during the study period and within 3 months after the last dose; The pregnancy test of female subjects of childbearing age within 7 days before administration must be negative
- Willing and able to read, understand, and sign written informed consent, parents/guardians of child or adolescent subjects have the ability to understand, agree, and sign research informed consent forms and applicable child consent forms before initiating any protocol related procedures
Age in the registry: 5 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.