Small Cell Carcinoma of Urinary System
Conditions
Interventions
Toripalimab With Combination Chemotherapy Group:Toripalimab, Cisplatin and Etoposide
Chemotherapy Group:Cisplatin and Etoposide
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of locally advanced or metastatic 1) naive small cell cancer of prostate bladder, urethra, or upper urinary tract; 2) prior systemic chemotherapy is allowed if > 6 months elapsed from last dose; 2. The participant signed written informed consent for the trial; 3. Aged 18 to 75 years old; 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; 5. Estimated survival time > 3 months; 6. The participant agreed to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion for biomarker evaluation; 7. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. 8. Well preserved organ function 1) White blood cell >= 4x10^9/L, neutrophil count>=2x10^9/L, Hemoglobin >=9 g/dL, Platelets >=100x10^9/L; 2) Total bilirubin ==3g/dL; 4) International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) = 30 mL/min.
Exclusion criteria
Exclusion criteria: 1. Has disease suitable for local treatment with curative intent; 2. Prior systematic anti-tumor therapy within 4 weeks from the last dose; 3. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette Guerin (BCG), and typhoid vaccine; 4. Prior clinical trial participant within last 4 weeks; 5. Has active autoimmune disease, or receives systemic corticosteroids treatment (>10mg/d); 6. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded; 7. A history of prostate cancer that was identified incidentally following radical cystectomy for bladder small cell cancer is acceptable provided that the PSA is 2.5 ULN, CK >ULN CK-MB >ULN; TnT>1.5 ULN; 2) Total bilirubin >1.5 ULN 3) prothrombin time (PT) or activated partial thromboplastin time (aPTT) >1.5 x ULN without anti coagulation therapy; 4) Hemoglobin < 10g/dl; Platelets < 100 x 10^9/L; neutrophil count <1.5 x10^9/L; 13. Not appropriate to participate in researchers view.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR assessed by RECIST1.1 criteria; | — |
Countries
China
Contacts
Public ContactLi Jing
Changhai Hospital, Shanghai
Outcome results
None listed