Upper tract urothelial carcinoma
Conditions
Interventions
Trial group:Toripalimab (240 mg, every 3 weeks, for 1 year) + Disitamab vedotin (2.0 mg/kg, every 3 weeks, for 8 cycles)
Control group:Toripalimab (240 mg, every 3 weeks, for 1 year)
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary participation in the clinical study; full understanding and awareness of the study, and signing of the informed consent form; willingness and ability to comply with and complete all trial procedures. 2.>=18 years of age. 3.Histologically confirmed UTUC staged pT3-4 Nany M0, pTany N+ M0, or ypT2-4 ypN+ after platinum-based neoadjuvant chemotherapy (according to the 8th edition of the AJCC TNM Staging System for UTUC). 4.Postoperative pathology is predominantly urothelial carcinoma, which may be combined with tumor heterologous differentiation, except for small cell carcinoma or urothelial carcinoma with neuroendocrine differentiation; 5.No history of concomitant muscle-invasive bladder cancer and no concomitant contralateral upper tract urothelial carcinoma. 6.Patients who did not receive platinum-based neoadjuvant chemotherapy were intolerant to platinum-based adjuvant chemotherapy after radical tumor resection (according to EORTC criteria): WHO or ECOG PS of 2, or Karnofsky PS of 60%-70% Creatinine clearance rate =2 hearing loss CTCAE grade >=2 peripheral neuropathy Elderly patients with severe cardiovascular and cerebrovascular underlying diseases Patients with New York Heart Association (NYHA) functional classification = 1 year. 10.Organ and hematologic function must meet the following requirements: Hemoglobin (HGB) >= 70 g/L. White Blood Cell Count (WBC) >= 3.0 × 10^9/L. Absolute Neutrophil Count (ANC) >= 1.5 × 10^9/L. Platelet Count (PLT) >= 80 × 10^9/L. Total Bilirubin (TBIL) = 30 mL/min. International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 × ULN. 11.Female subjects of childbearing potential must agree to take effective contraceptive measures after signing the ICF, during the study, and for 6 months after the last dose of Vidicitumab. Females of childbearing potential must have a negative serum pregnancy test within 7 days before trial screening. Any male or female patient of childbearing potential must agree to use effective contraception throughout the trial and for 6 months after the trial ends. For the purpose of this study, a patient is considered to be of childbearing potential if they are biologically capable of having children and have normal sexual activity, as determined by the investigator.
Exclusion criteria
Exclusion criteria: 1.Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology; 2.Evidence of distant metastases; 3.History of concomitant muscle-invasive bladder cancer or contralateral upper tract urothelial carcinoma. 4.Patients with negative HER2 immunohistochemical expression (IHC: 0); 5.Prior HER2-targeted therapy for urothelial carcinoma, or prior neoadjuvant therapy containing immune checkpoint inhibitors such as Toripalimab. 6.Concurrent participation in another clinical trial involving investigational drugs for urothelial carcinoma. 7.Pregnancy or lactation. 8.Presence of severe concurrent medical conditions, including but not limited to: Severe infections. Uncontrolled diabetes. Cardiovascular diseases (e.g., NYHA Class III or IV heart failure, second-degree or greater heart block, myocardial infarction within the past 6 months, unstable arrhythmias or unstable angina, cerebrovascular accident within the past 3 months). Severe pulmonary diseases (e.g., interstitial lung disease, severe chronic obstructive pulmonary disease, or history of symptomatic bronchospasm). 9.History of significant neurological or psychiatric disorders, such as epilepsy or dementia, or poor compliance. 10.History of drug or substance abuse. 11.Other active malignancies within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix. 12.Any other severe, acute, or chronic medical or laboratory abnormality that, in the investigator's judgment, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results. 13.Any other condition deemed by the investigator to make the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 years Disease-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median progression-free survival;Median metastasis-free survival;Overall survival;2-year bladder recurrence-free survival;Median disease-free survival;Qualify of life symptom scores;Median local recurrence-free survival; | — |
Countries
China
Contacts
Public ContactYao Kai
Sun Yat-sen University Cancer Center
Outcome results
None listed