GCTPhase 2NCT07188441
Treatment of Newly Diagnosed Central Malignant Germ Cell Tumor People With Teniposide Injection Combined With Cisplatin.
A Phase 2 study testing Teniposide Injection in people with GCT and Germ Cell Tumor, run by Chengcheng Guo at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- GCT, Germ Cell Tumor, Central Malignant Germ Cell Tumor
- What is being tested?
- Teniposide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Chengcheng Guo, 020-87343890, guochch@sysucc.org.cn
About this study
Official 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.
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.
- Conditions
- GCT, Germ Cell Tumor, Central Malignant Germ Cell Tumor
- Being tested
- Teniposide Injection
- Keywords
- Central malignant germ cell tumor, GCT, teniposide, Cisplatin
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teniposide InjectionDrug
Also called cisplatin
teniposide 300mg/m2 for 5 days, cisplatin 75mg/m2 for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Teniposide plus cisplatin | Experimental | 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. Receives: Drug: Teniposide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start13 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GCTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengcheng Guo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chengcheng Guo, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188441
- Sponsor's protocol ID
- TNBG-002
- Status last verified
- Sep 2025
- First submitted
- 23 Jul 2024
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07188441
- Acronym / sponsor ID
- TNBG-002
- Conditions
- GCT, Germ Cell Tumor, Central Malignant Germ Cell Tumor
- Keywords
- Central malignant germ cell tumor, GCT, teniposide, Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chengcheng GuoUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teniposide plus cisplatin | Experimental | Drug: Teniposide InjectionOur 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teniposide InjectionAlso: cisplatinteniposide 300mg/m2 for 5 days, cisplatin 75mg/m2 for 5 days | Drug | Teniposide plus cisplatin |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teniposide Injection in people with GCT and Germ Cell Tumor, run by Chengcheng Guo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact chengcheng Guo, Doctor of Medicine (020-87343890, guochch@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: 3 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.