High-risk upper urinary tract urothelial carcinoma
Conditions
Interventions
Experimental group:Radiotherapy combined with Sacituzumab Tirumotecan and Toripalimab
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Clearly diagnosed as urothelial carcinoma; the presence or absence of squamous or glandular metaplasia or CIS is not restricted, but components of squamous cell carcinoma or adenocarcinoma cannot be included. 2. Solitary kidney, contralateral kidney dysfunction, or bilateral multiple UTUC; 3. Preoperative stratification as high-risk UTUC with clinical stage =18 years, expected life expectancy greater than 1 year, ECOG performance status 0-2; 7. Major organ function: no significant abnormalities in liver, bone marrow, heart, and other important organs. Total bilirubin =3.5×10^9/L, neutrophils >=1.5×10^9/L, hemoglobin >=80 g/L, platelets >=75×10^9/L. ECG shows no significant abnormality or abnormalities are clinically insignificant. 8. Voluntarily agrees to participate in this study and signs the informed consent form. 9. Willing and able to comply with the trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1.History of previous abdominal and pelvic radiotherapy or having contraindications to pelvic radiotherapy; 2.Those with a history of allergic reactions to immunotherapy. 3.T3 and above or positive lymph nodes; 4.Renal pelvis and ureter non-urothelial carcinoma (squamous cell carcinoma, adenocarcinoma, small cell carcinoma); 5.Combined with muscle-invasive bladder cancer; 6.Pregnant and breastfeeding patients; 7.Severe liver dysfunction, combined with other serious diseases; active hepatitis B or hepatitis C infection; 8.Known to have severe cardiovascular disease, including any of the following conditions: myocardial infarction, arteritis, or venous thromboembolism events (such as pulmonary embolism) in the past 6 months; severe/unstable angina; heart failure reaching New York Heart Association (NYHA) class III or IV; ventricular arrhythmias requiring medication. 9.History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases) or history of organ transplantation; 10.Has a history of severe central nervous system disease. Has a history of epilepsy or any history that may trigger epilepsy, including unexplained loss of consciousness or transient cerebral ischemic attacks; 11.In the past 5 years, excluding other malignant tumors, cured basal cell carcinoma of the skin and carcinoma in situ of the cervix. 12.Unable to cooperate with regular follow-up observers due to psychological, social, family, and geographical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kidney disease-free survival (KIDFS, 12 months); | — |
Secondary
| Measure | Time frame |
|---|---|
| Creatinine clearance rate (compared to baseline at 12 months);Overall Survival, OS;Complete remission rate (CR, 12 months);Adverse event incidence;Pathological complete response (pCR);Quality of life assessment; | — |
Countries
China
Contacts
Public ContactZhuowei Liu
Sun Yat-sen University Cancer Center
Outcome results
None listed