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

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Teniposide Injection
  teniposide 300mg/m2 for 5 days, cisplatin 75mg/m2 for 5 days

Первичные конечные точки

• Objective response rate(ORR) [Срок оценки: 3 weeks.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07188441 · TNBG-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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