Advanced germ cell tumor
Conditions
Interventions
Trial group:Patients who met the enrollment criteria received toripalimab 240mg, IV infusion, Q3W, nab-paclitaxel 260 mg/m^2, IV on D1, ifosfamide 1500 mg/m^2, IV on D2-5, cisplatin 25 mg/m^2, IV on D
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
13 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntary signed informed consent; 2. Age >= 12 years; 3. Histologically or cytologically confirmed advanced recurrent or metastatic germ cell tumor; 4. ECOG performance status score of 0–1; 5. Expected survival of at least 12 weeks; 6. Presence of measurable disease; 7. Adequate function of major organs (liver, kidney, hematologic system, etc.): (1) Hemoglobin >= 9.0 g/dL (may be maintained or exceeded with transfusion); (2) Red blood cell count >= 2.0 × 10^12/L; (3) Absolute neutrophil count (ANC) >= 1.0 × 10^9/L; (4) Platelet count >= 100 × 10^9/L; (5) Total serum bilirubin <= 1.5 × upper limit of normal (ULN); (6) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase <= 2.5 × ULN; (7) For patients not receiving anticoagulation therapy: prothrombin time international normalized ratio (INR) <= 1.5, and activated partial thromboplastin time (APTT) <= 1.5 × ULN; for patients receiving full-dose or parenteral anticoagulation, enrollment is permitted if anticoagulant dosage has been stable for at least 2 weeks prior to study entry and coagulation test results remain within the therapeutic range defined by local clinical practice; 8. Adequate cardiopulmonary function to tolerate surgical intervention; 9. Contraception requirements: (1) Women of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment, and must use reliable contraception (e.g., intrauterine device, oral contraceptives, or condoms) from the start of treatment until 30 days after study completion; (2) Men of childbearing potential must use condoms during the study and for 30 days after study completion.
Exclusion criteria
Exclusion criteria: 1. Patients with malignancies other than germ cell tumors within five years before the start of this trial; 2. Combined with unstable systemic diseases, such as uncontrolled hypertension, severe arrhythmia, etc.; 3. Active, known or suspected autoimmune disease, or autoimmune paraneoplastic syndrome requiring systemic treatment; 4. Allergy to the test drug; 5. Have or currently have interstitial lung disease; 6. Combined with HIV infection or active viral hepatitis; 7. Pregnant or breastfeeding women; 8. Any malabsorption; 9. Those who suffer from neurological diseases or mental illnesses and cannot cooperate; 10. Being treated with traditional Chinese medicine or Chinese patent medicine with anti-tumor effect; 11. Cases that other researchers considered unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Progression Free Survival; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed