malignant ovarian germ cell tumor
Conditions
Interventions
Test group:Trastuzumab + BEP chemotherapy regimen
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old, = 75 years old, gender not restricted; 2. Diagnosis of germ cell tumors confirmed by imaging or laboratory tests, including spermatocytic tumors, non-spermatocytic tumors or mixed types, primary intra-glandular or extra-glandular primary tumors are acceptable; 3. No previous related anti-tumor treatment; 4. At least one measurable lesion that meets the RECIST 1.1 criteria; 5. Laboratory tests meet the following standards: - Hemoglobin >= 100 g/L (female), 110 g/L (male) - Neutrophil count >= 2×10^9/L - Platelet count >= 100×10^9/L; - Creatinine = 60 mL/min (Cockcroft-Gault formula); - Total bilirubin = 30 g/L; 6. ECOG PS score 0 - 1; 7. Expected survival time >= 3 months; 8. For females: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and must take reliable contraceptive measures from the time of signing the informed consent form until 3 months after the last administration; 9. Understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with the following conditions: Known HIV infection, active hepatitis B (defined as HBV DNA positive) and hepatitis C (HCV RNA positive); Interstitial lung disease/pulmonary inflammation; Had active, suspected autoimmune disease requiring systemic treatment in the past 2 years; 2. Received live attenuated vaccines within 4 weeks before enrollment, or are expected to need to receive live attenuated vaccines during the study; 3. Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA grade III or IV); 4. Stroke or cerebrovascular events within 6 months before enrollment; 5. QTcF interval > 480 msec at screening, for patients with implanted ventricular pacemakers, QTcF > 500 msec; 6. Previously received hematopoietic stem cell or bone marrow transplantation; 7. Allergic to the study drug or its components; 8. Subjects considered not suitable to participate in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade >= 3 neutropenia in the first cycle of chemotherapy treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of grade 3/4 neutropenia during chemotherapy treatment;objective response rate;Disease Control Rate;The incidence of grade 3/4 thrombocytopenia during chemotherapy treatment;The incidence of grade 3/4 anemia during chemotherapy treatment;Progression-free survival;Overall survival;The usage rate of granulocyte colony-stimulating factor (G-CSF); | — |
Countries
China
Contacts
Public ContactDongyuan Zhu
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed