Phase
Condition
Testicular Cancer
Treatment
N/AClinical Study ID
Ages 1-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 anticancerchemotherapy:
Bone marrow function met the following criteria:
Absolute neutrophil count (ANC) ≥ 1.0 × 109 / L;
Platelet count ≥ 100.0 × 109 / L (not after platelet transfusion);
Liver and kidney function should meet the following criteria:
Bilirubin (the sum of bound and unconjugated) ≤ 1.5 × upper limit of normal value (ULN) (corresponding to age). Patients with confirmed Gilbert's syndrome can beclassified according to the researcher;
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
Estimated glomerular filtration rate ≥ 70 ml / min / 1.73 m2 or normal serumcreatinine (CR);
Adequate pulmonary function: no dyspnea at rest, no exercise intolerance, pulse oxygensaturation > 94% (if there are clinical symptoms);
Cardiac function:
LVEF ≥ 50% was detected by echocardiography;
There was no history of arrhythmia requiring drug intervention before enrollment;
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 consentform before starting any program related procedures; subject has the ability toexpress consent (when applicable) with the consent of parents / guardians.
Exclusion
Exclusion Criteria: Patients with any of the following items will not be enrolled in this study:
Patients with recurrent germ cell tumor were treated by surgery alone previously;
Patients with immature teratoma (any grade);
Patients with sex cord stroma;
HBsAg positive patients;
Patients with HIV or syphilis infection;
Patients who had received organ transplantation before;
Uncontrolled active systemic bacterial, viral or fungal infections;