Malignant Ovarian Germ Cell Tumor
Conditions
Interventions
nintedanib group (experimental group):standard BEP regimen chemotherapy with nintedanib 150mg bid po till the end of treatment
placebo group (control group):standard BEP regimen chemotherapy with plabeco 150mg bid po till the end of treatment
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
14 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Women with malignant germ cell tumor and patients treated with chemotherapy regimen containing bleomycin; 2. Aged >= 14 years; 3. Can complete lung function examination; 4. FVC is greater than 45% of the normal predicted value and DLCO is greater than 60% of the normal predicted value; 5. Informed consent and signed informed consent; 6. Good compliance.
Exclusion criteria
Exclusion criteria: 1. Patients with preexisting pulmonary interstitial disease; 2. Patients with severe medical diseases, severe liver function impairment (aminotransferase increased to 2.5 times or more of the normal upper limit), and severe renal function impairment (creatinine clearance <30mL/min); 3. Patients with malignant tumors of other reproductive system; 4. Complicated with deep vein thrombosis, pulmonary embolism, myocardial infarction and cerebral infarction; 5. Patients with other diseases requiring long-term hormone therapy or who were considered unsuitable for inclusion by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute decline value in forced vital capacity (ml);Percent decline in predicted forced vital capacity (ml);Carbon monoxide dispersion (DLCO) decline rate (%); | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety and adverse effects of nintedanib in the treatment of malignant ovarian germ cell tumors;Onlogical outcomes of patients between two groups;Fertility outcomes of patients between two groups;Quality of life patients between two groups; | — |
Countries
China
Contacts
Public ContactYang Jiaxin
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed