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RecruitingNCT07188441Updated Sep 23, 2025

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

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

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 1 month later.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
5 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Central malignant germ cell tumor
  • GCT
  • teniposide
  • Cisplatin
03

In context

Neoplasms, Germ Cell and Embryonal

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 →

Lead sponsor

Chengcheng Guo is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Teniposide plus cisplatin

    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

Interventions

  • DrugTeniposide Injection

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

    Also known as: cisplatin

06

What researchers measure

Primary outcomes

  1. 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.

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07188441
Lead sponsor
Chengcheng Guo
Responsible party
Chengcheng Guo (MD,Principal Investigator,Clinicial Professor, Sun Yat-sen University) — Sponsor-investigator
First posted
Sep 23, 2025
Start date
Aug 13, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 23, 2025

Study contacts

chengcheng Guo, Doctor of Medicine
Contact
guochch@sysucc.org.cn
020-87343890

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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