Bladder cancer
Conditions
Interventions
Adjuvant radiotherapy combined with Sintilimab after radical resection of bladder cancer:Patients will receive adjuvant Sintilimab combined with radiotherapy after surgery. The total course of therapy
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: To be eligible for this study, patients must meet all of the following criteria: 1. Male or female, aged 18-80 years; 2. ECOG 0-2 points; 3. Life expectancy =6 months; 4. Radical cystectomy was performed, and the postoperative pathological diagnosis was myoinfiltrating urothelial carcinoma, or urothelial carcinoma (>50%) with other types of differentiation; 5. No neoadjuvant chemotherapy, or insufficient course of neoadjuvant chemotherapy; 6. Presence of at least one risk factor: (1) ypT2-T4a or ypN+ receiving neoadjuvant cisplatin chemotherapy; (2) Those who have not received cisplatin neoadjuvant chemotherapy and are not suitable for or refuse cisplatin adjuvant chemotherapy pT3-T4a or pN+, not suitable for cisplatin is defined as Ccr < 60ml/min, = grade 2 hearing impairment, = grade 2 peripheral nerve injury, or ECOG 2 score; (3) Positive incisal margin; (4) Lymph node dissection <10; 7. No significant dysfunction of major organ function; (1) Blood routine examination criteria must meet: Hemoglobin (HB) =90g/L; Neutrophil (ANC) =1.5×109/L; Platelet (PLT) =100×109/L; (2) No functional organic disease, must meet the following criteria: Serum total bilirubin =1.5 X ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3×ULN; 8. Men and women of childbearing age used highly effective contraceptive methods during the trial, and continue to use contraception for 12 months after treatment ends. 9. With the patient's consent and signed informed consent form, the patient is willing and capable of following the planned visits, research treatments, laboratory tests, and other experimental procedures.
Exclusion criteria
Exclusion criteria: Subjects who meet the following criteria are not eligible for admission to this study: 1. Imaging suggests local recurrence, residual or distant metastasis; 2. Only partial cystectomy was performed. 3. There are contraindications to radiotherapy; 4. Adjuvant chemotherapy has been performed after radical surgery; 5. There are serious or uncontrollable co-diseases that may affect the study protocol as determined by the investigator; 6. Serious adverse reactions occurred during previous immunotherapy; 7. Allergic to any component of the investigational drug; 8. Suffering from autoimmune diseases (except type I diabetes, hypothyroidism, vitiligo and other autoimmune diseases requiring hormone replacement treatment only, or psoriasis without systemic drug treatment); 9. Within 14 days prior to enrollment, the patient is receiving systemic glucocorticoid treatment (>10mg prednisone) or immunosuppressive agents, but inhaled glucocorticoids or physiological supplements are allowed; 10. Known human immunodeficiency virus (HIV) infection, or active HCV infection (HCV antibody positive and HCV RNA levels above the detection limit); 11. Active hepatitis B without treatment (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center), except; (1) Before enrollment, if the HBV viral load is less than 1000 copies/ml (200IU/ml), subjects should receive anti HBV treatment throughout the entire study drug treatment period to avoid virus reactivation (2) For subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not required, but close monitoring of viral reactivation is necessary 12. Other malignant diseases (excluding radical tumors, such as skin basal cell carcinoma, carcinoma in situ, prostate cancer and breast cancer) existed within 3 years before enrollment; 13. Pregnant or lactating women; 14. Those deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Locoregional recurrence-free survival;Distant metastasis-free survival;Overall survival;Disease-specific survival; | — |
Countries
China
Contacts
Public ContactZhuowei Liu
Sun Yat-sen University Cancer Center
Outcome results
None listed