Bladder cancer
Conditions
Interventions
Trial group:Tislelizumab was administered intravenously at a dose of 200 mg every three weeks for a total of 8 cycles. Radiotherapy was delivered with conventional fractionation, under image guidance
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The diagnosis of bladder urothelial carcinoma was confirmed as non muscle invasive bladder urothelial carcinoma. The presence or absence of squamous epithelium, metaplasia of glandular epithelium or the presence or absence of CIS were not limited. 2. CIS with or without TA or T1 confirmed by pathology or high-grade Ta / T1 with BCG treatment failure confirmed by pathology; within 9 months after BCG perfusion; 2; 3. The tumor should be resected by transurethral resection of bladder tumor to the greatest extent, except for carcinoma in situ; 4. BCG treatment failure included: (1) persistent or recurrent CIS (+ / - recurrent Ta / T1 disease) within 9 months after receiving adequate BCG treatment ((at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 doses of maintenance therapy) or 9 months after the end of BCG perfusion; (2) High grade Ta / T1 disease recurred within 6 months after receiving sufficient BCG treatment ((at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 doses of maintenance therapy) or 6 months after the end of BCG perfusion; (3) T1 / high-grade tumor only in the first evaluation during BCG induction (at least 5 of the 6 initial induction treatment courses); and (4) severe side effects during BCG infusion need to be terminated. 5. The patients were not suitable or refused to undergo total cystectomy; 6. Age 18-80 years, life expectancy more than 2 years, ECoG score 0-2 (see Appendix 1). 7. Function of main organs: liver, kidney, bone marrow, heart and other important organs have no obvious abnormality. Total bilirubin = 3.5 * 10^9 / L, neutrophil >= 1.5 * 10^9 / L, hemoglobin >= 90 g / L, Platelet >= 80 * 10^9 / L; There was no obvious abnormality in ECG, or the abnormality had no clinical significance. 8. Volunteer to participate in the study and sign informed consent. 9. Willing and able to follow the trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. High grade Ta / T1 recurred 6 months after BCG perfusion, or low grade recurrence after BCG perfusion; 2. CIS recurred 9 months after BCG infusion; 3. Muscle invasive bladder cancer appeared during BCG perfusion; 4. Previous history of pelvic radiotherapy or contraindications of pelvic radiotherapy; 5. Previous PD-1 treatment history or allergy to immunotherapy; 6. Invasive or metastatic bladder urothelial carcinoma; 7. Non urothelial carcinoma of bladder (squamous cell carcinoma, adenocarcinoma, small cell carcinoma); 8. There were upper urinary tract urothelial carcinoma; 9. Pregnant and lactating patients; 10. Severe liver and kidney dysfunction combined with other serious diseases; active hepatitis B or hepatitis C infection; 11. Known serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis events (such as pulmonary embolism) in the past 6 months; severe / unstable angina pectoris; heart failure, reaching NYHA standard grade III or IV; ventricular arrhythmia requiring drug treatment; and; 12. History of immunodeficiency (including HIV positive, other acquired and congenital immunodeficiency diseases) or organ transplantation history; 13. History of severe central nervous system diseases. Have a history of epilepsy or any history that may induce epilepsy, including unexplained loss of consciousness or transient ischemic attack; 14. Other malignant tumors were found in the past five years, except for skin basal cell carcinoma and cervical carcinoma in situ; 15. Those who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Complete Response? Rate;Preservation rate of bladder;Quality of life assessment; | — |
Countries
China
Contacts
Public ContactZhuowei Liu
Sun Yat-Sen University Cancer Center
Outcome results
None listed