Upper Tract Urothelial Carcinoma
Conditions
Interventions
Experimental Group (single-arm):Tislelizumab: 200mg IVD Q3W, administered continuously for a total of 1 year (17 cycles), or until disease progression or intolerable toxicity.
Radiotherapy: Initiated
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study must meet all of the following criteria: 1.Male or female, aged >=18 years; 2.ECOG score of 0-2; 3.Have undergone radical nephroureterectomy with postoperative pathological confirmation of urothelial carcinoma, or urothelial carcinoma (>50%) with other types of differentiation; 4.Presence of at least one high-risk factor: pathological stage pT3-4/ypT2-4, R1/R2 resection, positive postoperative lymph nodes, or inadequate lymph node dissection; 5.Refusal of chemotherapy or intolerance to cisplatin-based chemotherapy (meeting one or more of the following criteria: defined as creatinine clearance (Ccr) =Grade 2 hearing impairment, >=Grade 2 peripheral neuropathy, ECOG score of 2); 6.No significant dysfunction of major organs: (1) Blood routine examination criteria must meet: Hemoglobin (HB) >=90 g/L; Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count (PLT) >=100×10^9/L; (2) No functional organic diseases, must meet the following criteria: Total serum bilirubin <=1.5 × Upper Limit of Normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<=3×ULN; 7.Fertile males and females must use highly effective contraceptive methods during the trial and continue contraception for 12 months after treatment completion; 8.Have provided written informed consent, willingly and capable of complying with scheduled visits, study treatments, laboratory tests, and other experimental procedures.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are not eligible for inclusion in this study: 1.Imaging indicates local recurrence or distant metastasis; 2.Presence of contraindications for radiotherapy; 3.Have received adjuvant chemotherapy after radical surgery; 4.Presence of severe or uncontrollable concomitant diseases that, in the opinion of the investigator, may affect the study protocol; 5.Have experienced severe adverse reactions during previous immunotherapy; 6.Are allergic to any component of the study drug; 7.Have an autoimmune disease (except for autoimmune diseases such as Type 1 diabetes, hypothyroidism, vitiligo that only require hormone replacement therapy, or psoriasis that does not require systemic drug treatment); 8.Are receiving systemic glucocorticoid therapy (>10 mg of prednisone) or immunosuppressants within 14 days prior to enrollment, except for inhaled glucocorticoids or physiological supplements; 9.Known human immunodeficiency virus (HIV) infection, or active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA level above the lower limit of detection); 10.Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA copies above the upper limit of normal for the testing laboratory at the study site), except: (1) Subjects with an HBV viral load <1000 copies/ml (200 IU/ml) prior to enrollment should receive anti-HBV treatment during the entire study drug treatment period to avoid viral reactivation. (2) Subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and have an undetectable HBV viral load do not need prophylactic anti-HBV treatment but should be closely monitored for viral reactivation. 11.Presence of other malignant diseases within the past 3 years (excluding cured tumors such as basal cell carcinoma of the skin, carcinoma in situ, prostate cancer, and breast cancer, etc.); 12.Pregnant or lactating women; 13.Subjects deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival (DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Locoregional Recurrence-Free Survival (LRFS);Distant Metastasis-Free Survival (DMFS);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactZhuowei Liu
Sun Yat-Sen University Cancer Center
Outcome results
None listed