Bladder cancer
Conditions
Interventions
60mg group:Clostridium butyricum dose group 1: 60 mg bid.
The neoadjuvant regimen consisted of tilelizumab (fixed dose, 240mg), cisplatin (70mg/m2) and gemcitabine (1000mg/m2).
80mg group:Clostridium butyricum dose group 1: 80 mg bid.
The neoadjuvant regimen consisted of tilelizumab (fixed dose, 240mg), cisplatin (70mg/m2) and gemcitabine (1000mg/m2).
Sponsors
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily agree to participate in the study and sign the informed consent form; 2. Male or female, aged 18-75 years (inclusive of cut-off values); 3. cT2-T4aN0M0 bladder urothelial carcinoma patients with residual lesions after TURBT based on TNM staging of bladder cancer, 8th edition of AJCC, histological diagnosis and imaging evaluation; Patients with mixed tumors were required to have a predominant urothelial carcinoma. 4. Serum butyric acid level =1.5x10^9/L 2) platelet count >=100×10^9/L 3) hemoglobin >=90g/L (2) International normalized ratio or activated partial thromboplastin time =60mL/min (4) Serum total bilirubin <=1.5×ULN (<=3×ULN if Gilbert's syndrome or indirect bilirubin concentration shows extrahepatic elevation) (5) AST, ALT and alkaline phosphatase <=2.5×ULN (6) Pulmonary function indicated that the patient could tolerate major abdominal surgery 10. Female participants should be surgically sterilized, postmenopausal, or agree to use at least one medically approved contraceptive method (e.g., an intrauterine device, contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment period. Blood pregnancy tests must be negative within 7 days before study enrollment. Male subjects should agree to use at least one medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period; 11. Be willing and able to follow trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Prior therapy targeting PD-1,PD-L1,PD-L2, CTLA4, or other antibody or drug therapy specifically targeting T cell costimulation or checkpoint channels. 2. Are using or plan to use during treatment foods or drugs that have a large impact on gut microbiota (including but not limited to probiotics, yogurt) 3. Previous history of allergy to microecological agents 4. Known symptoms or diseases (e.g., diarrhea, acute diverticulitis) that the investigator considers to increase the risk of study participation or interfere with the interpretation of the safety results 5. Receipt of other approved systemic anticancer therapy or systemic immunomodulatory agents (including, but not limited to, interferon, interleukin-2, and tumor necrosis factor) within 28 days before enrollment. 6. Prior radiation therapy for bladder cancer. 7. Previous medical therapy for the tumor, except for: a. For patients who had previously received systemic chemotherapy, a treatment-free interval of at least 12 months from the last treatment to the start of neoadjuvant therapy; b. Local intravesical chemotherapy or immunotherapy was completed at least 1 week before the start of study neoadjuvant therapy. 8. Major surgery or major trauma within 28 days before enrollment (placement of vascular access devices and TURBT were not considered major surgery). 9. Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before enrollment. 10. Vaccination with live vaccine within 28 days before enrollment (seasonal influenza vaccines are usually inactivated and are therefore allowed. Intranasal vaccines are live vaccines and are not allowed). 11. Active autoimmune disease requiring systemic therapy that is considered by the investigator to have an impact on the study treatment. 12. Requiring long-term and heavy use of hormones or other immunosuppressive agents, which are considered by the investigator to have an impact on the study treatment. 13. A history of potassium, sodium, or calcium abnormalities or hypoalbuminemia, interstitial lung disease, noninfectious pneumonia, or other uncontrolled systemic illness, including diabetes, hypertension, cardiovascular disease (e.g., active cardiac disease within 6 months before enrollment), or diabetes, as determined by the investigator, that could affect treatment. Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medical treatment). 14. Untreated chronic hepatitis B subjects or hepatitis B virus (HBV) carriers with HBV DNA=500IU/mL (2500 copies /mL) were not allowed to enter the study. Note: Patients with inactive hepatitis B surface antigen carriers or active HBV infection (HBV DNA < 500IU per milliliter [2500 copies per milliliter]) that was stable after continuous antiviral therapy were eligible for enrollment. HBV DNA testing was performed only in patients who were positive for antibodies against the hepatitis B core antigen. 15. Patients with active hepatitis C were not eligible. Patients who tested negative for HCV antibodies at screening or who tested negative for HCV RNA after testing positive for HCV antibodies were eligible for enrollment. HCV RNA testing is required in patients who test positive only for HCV antibodies. 16. A history of immunodeficiency (including positive human immunodeficiency virus HIV test, other acquired or congenital immunodeficiency disorders) or allogeneic stem cell or org
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Countries
China
Contacts
Public ContactLin Tianxin
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Outcome results
None listed