Recruiting

Teniposide and Cisplatin for Central Malignant Germ Cell Tumors

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What is being tested

Teniposide Injection

Drug
Who is being recruted

Neoplasms

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

Over 5 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorChengcheng Guo
Study Contactchengcheng Guo, Doctor of Medicine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 13, 2024

Actual date on which the first participant was enrolled.

This study is focused on testing a combination of two drugs, Teniposide and Cisplatin, to treat newly diagnosed patients with central malignant germ cell tumors. These types of tumors occur in the brain or spinal cord and are particularly challenging to treat. The study aims to find out if this drug combination can effectively reduce or control the tumor, offering a new treatment option for patients facing this serious condition. Understanding how these drugs work together could lead to better treatment strategies for people with this rare and aggressive type of tumor. Participants in the study receive the treatment through an injection. Teniposide is given with Cisplatin every three weeks, and each cycle lasts between three to five days. The treatment involves a specific dosage of the drugs delivered through an intravenous drip, mixed with saline solution. Patients undergo up to six cycles of this combination therapy. After completing the chemotherapy cycles, standard radiation therapy is applied to further target tumor cells. The study does not list specific outcomes being measured, but the main goal is to evaluate the effectiveness and safety of this drug combination in managing the tumors.

Official TitleA 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.
NCT07188441
Principal SponsorChengcheng Guo
Study Contactchengcheng Guo, Doctor of Medicine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 5 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and Embryonal

Criteria

10 inclusion criteria required to participate
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

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12 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Sun Yat-sen University Cancer Center

Guangzhou, ChinaOpen Sun Yat-sen University Cancer Center in Google Maps
Recruiting
One Study Center