Toripalimab Plus Etoposide and Platinum-based Chemotherapy for Genitourinary Small Cell Carcinoma

Who cannot join

• Received treatment for small cell carcinoma of the urinary system within 2 weeks before enrollment.
• Once diagnosed with prostate adenocarcinoma, received endocrine therapy (such as enzalutamide, apalutamide, abiraterone, etc.) and chemotherapy (docetaxel) for prostate adenocarcinoma, and is currently considering neuroendocrine differentiation of prostate cancer.
• Mixed small cell carcinoma, in which the small cell carcinoma component is less than 50%.
• Medical history and comorbidities:
• Anti-tumor vaccine or cellular immunotherapy has been used before the first dose of the study drug; (2) Previously received systemic therapy for metastatic lesions; (3) The patient is participating in other interventional clinical studies or less than 4 weeks before the end of the previous clinical study; (4) Those who have been less than 4 weeks away from the last anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy or local-regional treatment). The adverse reactions related to anti-tumor treatment (except hair loss) after the previous systemic anti-tumor treatment have not recovered to NCI-CTC AE≤level 1; (5) Live vaccines have been vaccinated within 4 weeks before administration of the study drug. Inactivated virus vaccines for seasonal influenza and injection are allowed, but attenuated live influenza vaccines for intranasal administration are not allowed; (6) The subject has any active, known or suspected autoimmune disease. Subjects who are in a stable state and do not require systemic immunosuppressant therapy are allowed to be enrolled; (7) Subjects who required systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent doses of other glucocorticoids) or other immunosuppressants within 14 days before the first dose of study drug. Steroid replacement with inhaled or topical steroids and curative doses of prednisone at doses > 10 mg/day is permitted in the absence of active autoimmune disease; (8) Patients with a known history of interstitial pneumonia or highly suspected interstitial pneumonia; or patients who may interfere with the detection or treatment of suspected drug-related pulmonary toxicity; (9) Other active malignant tumors that require simultaneous treatment; (10) Has a history of malignant tumors. Patients with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ who underwent potentially curative therapy and had no disease recurrence within 5 years from the end of treatment were excluded; (11) Known history of organ transplantation and allogeneic hematopoietic stem cell transplantation;(12) Subjects who have undergone major surgery or severe trauma have less than 14 days before enrollment; (13) Patients with active pulmonary tuberculosis should be excluded. Patients suspected of having active pulmonary tuberculosis should be checked for chest X-ray, sputum, and ruled out by clinical symptoms and signs. Patients with a history of active tuberculosis infection within the previous 1 year, even if treated, should be excluded; patients with a history of active tuberculosis infection more than 1 year ago should also be excluded. Unless it is proven that the duration and type of antituberculosis treatment previously used was appropriate; (14) Severe acute or chronic infection requiring systemic therapy； (15) Heart failure (New York Heart Association Class III or IV) despite appropriate medical therapy. Patients with poorly controlled coronary artery disease or poorly controlled arrhythmia, or a history of myocardial infarction within 6 months prior to screening.
• 5. Neutrophil count <1.0×109/L, or hemoglobin <80g/L, or platelet count <90×109/L. Hepatic insufficiency not related to tumor (transaminase more than 3 times the upper limit of normal value and/or blood bilirubin greater than 2.0mg/dl). Renal insufficiency not related to tumor (serum creatinine clearance <30 mL/min calculated according to the CG formula).