Extracranial germ cell tumor
Conditions
Interventions
treatment group:albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin
Sponsors
Sun Yat-Sen University Cancer center
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 1-18 years; 2. ECoG PS score: 0-1; 3. Patients with malignant germ cell tumor of extracranial origin confirmed by histology at initial diagnosis or recurrence. 4. Patients who have received first-line chemotherapy and have progressed, relapsed or refractory after treatment (they have not achieved complete or partial remission after recent treatment); 5. Patients must have at least one measurable lesion defined by RECIST standard; 6. Patients whose estimated survival time is more than or equal to 6 months; 7. Patients must completely recover from all previous acute toxicity of anticancer chemotherapy (1) Myelosuppression chemotherapy: at least 21 days after the last myelosuppression chemotherapy; (2) Experimental drugs or anticancer therapies other than chemotherapy: it is necessary to make clear the complete recovery from the clinically significant toxicity of the therapy; (3) Hematopoietic growth factor: at least 14 days after the last administration of long-acting growth factor or 3 days after the last administration of short acting growth factor; (4) Immunotherapy: at least 42 days after completion of any type of immunotherapy (except steroids), such as immune checkpoint inhibitors and tumor vaccines; (5) X-ray therapy (XRT): at least 14 days after local palliative XRT (small area mouth); at least 42 days after other solid bone marrow (BM) irradiation, including 131I-MIBG; (6) Stem cell infusion without total body irradiation (TBI): there is no evidence of active graft-versus-host disease, and it must end at least 56 days after transplantation or stem cell infusion; 8. Patients whose bone marrow function meets the following criteria: (1) Absolute neutrophil count (ANC) >= 1.0 x 10^9 / L; (2) Platelet count >= 100.0 x 10^9 / L (after non platelet transfusion); Liver and kidney function should meet the following criteria (1) Patients with bilirubin (combined + unconjugated) = 70 ml / min / 1.73 m2 or normal serum creatinine (CR); 10. Adequate lung function: no dyspnea at rest, no exercise intolerance, pulse oxygen saturation > 94% (if there are clinical symptoms); 11. Cardiac function: (1) LVEF >= 50% detected by color Doppler echocardiography; (2) There was no history of arrhythmia requiring drug intervention before enrollment; 12. Patients with seizures that can be fully controlled without enzyme induced anticonvulsants; 13. Patients who were able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits during the study period; 14. 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 initiating any program related procedures; subjects have the ability to express their consent (when applicable) with the consent of parents / guardians.
Exclusion criteria
Exclusion criteria: 1. Patients with recurrent GCT treated by surgery alone; 2. Patients with simple immature teratoma (of any grade); 3. Patients with pure germ cell tumor; 4. Patients with sex cord stroma; 5. In patients without measurable lesions, only alpha fetoprotein (AFP) and / or ß - human chorionic gonadotropin (ß - hCG) were elevated; or only bone metastases were found by bone scan; 6. HBsAg positive patients; 7. Patients infected with HIV or syphilis; 8. Patients who have received organ transplantation in the past; 9. Patients with uncontrolled active systemic bacterial, viral or fungal infections; 10. Patients with previous or simultaneous active cardiovascular diseases of clinical significance, including congenital heart disease or pericardial disease, history of heart failure, myocardial infarction, coronary heart disease, heart valve disease, cardiomyopathy, arrhythmia (including persistent atrial fibrillation, complete left bundle branch block, frequent ventricular premature beat), or QT interval (QTc) extension > 480 ms after current corrected heart rate; 11. Subjects of pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactYizhuo Zhang
Sun Yat-Sen University Cancer Center
Outcome results
None listed