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The purpose is to evaluate the effectiveness and safety of albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin in the treatment of children patients with advanced, recurrent or refractory extracranial germ cell tumor.
Full description
Children patients with advanced, recurrent or refractory extracranial germ cell tumor were treated with albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin . This is a multi-center and single arm phase II clinical study.
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Inclusion criteria
Age: 1-18 years old;
ECOG PS score: 0-1;
Patients was confirmed pathologically with malignant germ cell tumor.
Patients with tumor progressed, relapsed or refractory after first-line chemotherapy, and complete or partial remission was not achieved after recent treatment.
Have at least one measurable lesion defined by RECIST standard;
The estimated survival time was more than 6 months;
Patients must fully recover from the acute toxicity of previous anticancer chemotherapy:
Bone marrow function met the following criteria:
Liver and kidney function should meet the following criteria:
Adequate pulmonary function: no dyspnea at rest, no exercise intolerance, pulse oxygen saturation > 94% (if there are clinical symptoms);
Cardiac function:
Seizures that can be fully controlled without enzyme-induced anticonvulsants;
During the study period, they were able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits;
Parents / guardians of child or adolescent subjects have the ability to understand, agree and sign the study informed consent form (ICF) and the applicable child consent form before starting any program related procedures; subject has the ability to express consent (when applicable) with the consent of parents / guardians.
Exclusion criteria
Patients with any of the following items will not be enrolled in this study:
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43 participants in 1 patient group
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Central trial contact
Yizhuo Zhang
Data sourced from clinicaltrials.gov
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