upper tract urothelial carcinoma
Conditions
Interventions
Active Comparator:Gemcitabine Plus Carboplatin
Experimental:Disitamab Vedotin Plus Radiotherapy
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily agree to participate in the study and sign the informed consent form; 2. Male or female, over 18 years old; expected survival >= 6 months; 3. Patients with upper urinary tract urothelial carcinoma confirmed by postoperative histopathology; 4. Clinical staging meets (1) pT3~pT4, N0, M0; (2) pTany, N, M0; 5. HER2 immunohistochemical expression in postoperative tumor tissue confirmed positive by the researcher: IHC 1, 2, or 3; 6. Cisplatin-intolerant population, meeting at least one of the following criteria: (1) GFR 50%; (2) Hemoglobin > 9 g/dL; (3) Absolute neutrophil count (ANC) > 1.5 x 10^9/L; (4) Platelets > 100 x 10^9/L; (5) Total serum bilirubin 50 mL/min according to the Cockcroft-Gault formula; 10. For female subjects: must be surgically sterile, postmenopausal, or agree to use at least one medically recognized contraception method (e.g., IUD, birth control pills, or condoms) during the study treatment and for 6 months after; serum pregnancy test must be negative within 7 days before enrollment, and must not be breastfeeding. Male subjects must agree to use at least one medically recognized contraception method (e.g., condoms) during the study treatment and for 6 months after; 11. Willing and able to comply with the trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Had anti-tumor treatments before starting the study drug, including radiotherapy, targeted therapy, immunotherapy, or participation in clinical trials with anti-tumor drugs; 2. Had major surgery within 4 weeks before starting the study drug; 3. Serological virus tests (based on the study center's normal ranges): (1) HBsAg or HBcAb positive and HBV DNA detected; (2) HCV Ab positive (can only join the study if HCV RNA PCR test is negative); (3) HIV Ab positive; 4. Received a live vaccine within 4 weeks before study drug administration or plans to receive any vaccine during the study (except for COVID-19 vaccines); 5. Heart failure classified as NYHA class 3 or above; 6. Had serious arterial/venous thromboembolic events or cardiovascular/cerebrovascular incidents within 1 year before the study drug, such as deep vein thrombosis, pulmonary embolism, cerebral infarction, brain hemorrhage, myocardial infarction, etc. (except for asymptomatic lacunar infarctions that do not need clinical intervention); 7. Has active or progressive infections requiring systemic treatment, e.g., active pulmonary tuberculosis; 8. Has systemic diseases not stably controlled as judged by the investigator, including diabetes, hypertension, cirrhosis, interstitial pneumonia, obstructive lung disease, etc.; 9. Has active autoimmune disease requiring systemic therapy (like immunomodulators, corticosteroids, or immunosuppressants) before starting the study drug, although certain replacement therapies (like thyroid hormone, insulin, or physiological corticosteroid replacement for renal or pituitary insufficiency) are allowed; 10. Had other malignant tumors within 5 years before starting the study drug, except for those expected to be cured after treatment (including but not limited to sufficiently treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery); 11. History of allogeneic hematopoietic stem cell transplant or organ transplant; 12. Previously treated with PD-(L)1 inhibitors or other antibody-drug conjugates; 13. Known allergy to recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugates or any of their components; 14. Pregnant or breastfeeding women; 15. Any other diseases, metabolic abnormalities, abnormal physical exams, or lab results that, in the investigator's opinion, suggest the patient is not suitable for the study drug, may affect study results, or put the patient at high risk; 16. Estimated poor compliance with participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 years disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local recurrence-free survival, LRFS;Disease-free survival, DFS;Incidence of adverse events;Overall survival;Metastasis-free survival, MFS;Abnormalities in safety laboratory tests and clinical assessments;Patient-reported quality of life; | — |
Countries
China
Contacts
Public ContactXuesong Li
Peking University First Hospital
Outcome results
None listed