Urothelial Carcinoma
Conditions
Interventions
Single arm studies:Albumin Bound Paclitaxel plus Camrelizumab
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patient greater than 18 years of age; 2. Histologically or cytologically confirmed, locally advanced Stage 4 (T4bN0, anyTN2-3) or metastatic transitional cell cancer of the bladder; including other transitional cell cancers of the urothelium (prostate, urethra, ureter, and renal pelvis); 3. Progression or recurrence of urothelial cancer following a first-line platinum-containing regimen (e.g cisplatin, carboplatin) for metastatic or inoperable locally advanced disease; or adjuvant platinum-based therapy following cystectomy for localized muscle-invasive urothelial cancer with recurrence/progression <=12 months following completion of therapy; 4. No more than 2 prior lines of systemic chemotherapy for metastatic urothelial cancer, and have not received Paclitaxel; 5. At least 1 site of measurable disease by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1) guidelines; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; 7. No significant abnormalities are found in bone marrow, kidney, liver and blood coagulation function: Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 9.0 g/dL (a hemoglobin less than 9.0 g/dL at Screening is acceptable if it is corrected to greater than or equal to 10.0 g/dL by growth factor or transfusion prior to first dose), and platelet count greater than or equal to 100 x 10^9/L; 8. Patients must have adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limit of the normal range (ULN), and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN (in the case of liver metastases, less than or equal to 5 x ULN). If there are bone metastases, liver-specific alkaline phosphatase may be separated from the total and used to assess liver function instead of total alkaline phosphatase; has good oagulation function;8.The life expectancy is more than or equal to 3 months; 9. Ability to understand and willingness to sign a written informed consent; 10. Female participants of childbearing potential have a negative urine within 3 days before receiving the first study drug administration (cycle 1, day 1), or serum pregnancy test; 11. All enrolled subjects (male and female) must take adequate barrier methods for birth control during the entire treatment period and within 180 days after the end of treatment.
Exclusion criteria
Exclusion criteria: 1. Urothelial cancer that is suitable for local therapy administered with curative intent; 2. History of clinically symptomatic cardiovascular, liver, respiratory, renal, blood, endocrine or neuropsychiatric diseases; 3. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis; 4. CTCAE v.4.0 Grade greater than or equal to 1 peripheral neuropathy; 5. Anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not recovered from adverse events due to agents administered more than 4 weeks earlier; 6. Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to the first dose of trial medication; 7. Prior therapy with an anti-programmed cell death 1 (PD-1) or anti-PD-Ligand 1 agent, or with an agent directed to another co-inhibitory T-cell receptor (eg CTLA-4, OX-40, CD137); 8. Received an investigational agent, chemotherapy, biological therapy, hormonal therapy, targeted therapy, or radiotherapy within 28 days prior to commencing study treatment, or have not recovered from all treatment-related toxicities to Common Toxicity Criteria (CTC) Grade less than or equal to 1, except for alopecia; 9. History of severe hypersensitivity reaction to the active ingredients and/or any excipients of the study drug (>=3 grade); 10. Diagnosed with immunodeficiency or being on systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study; 11. Active autoimmune disease requiring systemic treatment within the past 2 years or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic or immunosuppressive agents; 12. Have undergone a solid organ or blood system transplant; 13. HIV positive; 14. Untreated active hepatitis B; 15. Subjects with active HCV infection received a live vaccine within 30 days before the first dose; 16. Other malignant tumors which have not been cured; 17. Any condition that is not stable or may jeopardize the safety of the subject and his/her compliance with the study; or other factors that the investigators believe that the subject is not suitable for participation in the study; 18. Women who are breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival ;Objective Response Rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Safety;health-related quality-of-life ; | — |
Countries
China
Contacts
Public ContactYanxia Shi
Sun Yat-Sen University Cancer Center
Outcome results
None listed