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NCT Number: NCT07188441

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

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.

Recruiting

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Chengcheng Guo

CONTACT

[email protected]

020-87343890

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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
  • Patients with Magnetic Resonance Imaging contraindications
  • Those who need to receive live virus vaccine during administration
  • 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
  • Patients who have undergone organ transplantation in the past
  • Pregnant or lactating women
  • Researchers believe that there are other factors that are not suitable for participating in the experiment

Treatment and study plan

Teniposide Injection

Drug

teniposide 300mg/m2 for 5 days, cisplatin 75mg/m2 for 5 days

Other names: cisplatin

Primary outcomes

  1. Objective response rate(ORR)

    Time frame: 3 weeks.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

chengcheng Guo, Doctor of Medicine

CONTACT

[email protected]

020-87343890

Sponsors and collaborators

Lead sponsor

Chengcheng Guo

Other

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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