upper tract urothelial carcinoma
Conditions
Interventions
Disitamab vedotin combined with tislelizumab treatment group:None
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary enrollment and written informed consent were obtained; 2. Age >=18 years old, male or female; 3. Participants with pathologically confirmed UTUC and at least one of the following criteria: (1) pT2 ( At least one of the following high-risk factors for recurrence must be present:tumor is at least G3/high grade;multiple or multicentric tumors;tumor diameter >= 2 cm; pathology includes other tissue components: including squamous cell carcinoma, adenocarcinoma, micropapillary carcinoma, sarcomatoid carcinoma, and lymphoepithelioma, etc.); (2) pT3-pT4; (3) pN+; (4) ypT2-ypT4a or ypN+ (for participants who received neoadjuvant chemotherapy or immunotherapy, except those who received neoadjuvant therapy with ADC drugs); 4. Cisplatin intolerance or no adjuvant platinum drugs; 5. Disease-free status was confirmed by imaging within 4 weeks before treatment; 6. Adjuvant therapy can be performed within 120 days after radical surgery; 7. HER2 immunohistochemical (IHC) test results of IHC 1+ or 2+ or 3+ were acceptable if the subject's previous test results (confirmed by the investigator) and the trial site results were acceptable; 8. The expected survival time was >= 6 months; 9. The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score was 0-1; 10. The function of main organs are normal, that is, they meet the following criteria: (1) Hematological examination (no blood transfusion or use of G-CSF within 14 days before screening) 1) Hemoglobin >= 90 g/L; 2) Absolute neutrophil count (ANC) >= 1.5×10^9/L; 3) White blood cell count >= 3.0×10^9/L; 4) Platelet count >= 80×10^9/L; (2) Blood biochemical examination (no use of albumin within 14 days before screening) 1) Albumin >=28 g/L; 2) Total bilirubin =50 mL/min; (3) Coagulation function 1) International normalized ratio (INR) or prothrombin time (PT) <=1.5×ULN; 2) Activated partial thromboplastin time (APTT) <=1.5×ULN.
Exclusion criteria
Exclusion criteria: 1. A history of malignancy other than urothelial carcinoma, except for the following two cases: (1) The participant has received potentially curative treatment and has no evidence of the presence of the disease within 5 years; (2) Successfully received resection of the skin basal cell carcinoma (BCC), squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ and other carcinoma in situ; 2. Prior allogeneic stem cell or solid organ transplantation; 3. Past or present congenital or acquired immunodeficiency disease; 4. Active or previously documented autoimmune or inflammatory diseases (including but not limited to: Autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyperthyroidism or hypothyroidism, asthma requiring bronchodilator treatment, etc.), vitiligo or asthma that had resolved completely in childhood, and without any intervention in adulthood; 5. Into the group 2 weeks before used systemic immunosuppression drug therapy, or during the study period is expected to systemic immunosuppression drug treatment, except the following: (1) Intranasal, inhaled, topical or locally injected (e.g. intra-articular) corticosteroids; (2) Dose not more than 10 mg/day prednisone or other effects of systemic corticosteroids; (3) Prophylactic corticosteroids for hypersensitivity reactions; 6. Participants with a known or suspected history of allergy to vedecitumumab/tislelizumab and similar drugs, or a history of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, or allergy to excipients of the study drug; 7. Thrombosis or thromboembolic events, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc. in the past 6 months; 8. Participants with severe bleeding risk, including but not limited to severe bleeding (bleeding > 30 ml within 3 months) and hemoptysis (bleeding > 5 ml within 4 weeks), can be assessed by the doctor. Gastroscopy/evaluation can be performed if the above conditions occur, and the endoscopic evaluation shall be the final. Or have active bleeding or abnormal coagulation function, have bleeding tendency or are receiving thrombolytic, anticoagulant or antiplatelet therapy; 9. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass graft surgery within the previous 6 months, congestive heart failure (New York Heart Association NYHA class >2), poorly controlled arrhythmia or arrhythmia requiring pacemaker therapy, Drug-uncontrolled hypertension (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg); 10. Other significant clinical and laboratory abnormalities that the investigator considered to affect the safety evaluation, such as uncontrolled diabetes mellitus, chronic kidney disease, grade II or higher peripheral neuropathy (CTCAE V5.0), thyroid dysfunction, etc.; 11. Severe infection in the active stage or with poor clinical control; Active infections, including: (1) HIV (HIV1/2 antibody) positive; (2) Active hepatitis B (HBsAg positive or HBV DNA > 2000IU/ml with abnormal liver function); (3) Active hepatitis C (HCV antibody positive or HCV RNA>=10^3 copies /ml with abnormal liver function); (4) Active TB; (5) Other uncontrolled active infections (CTCAE V5.0 > grade 2); 12. Has not recovered from surgery, if there is an un
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Metastasis-free survival;Local recurrence-free survival;Adverse events and serious adverse events;ECOG PS score; | — |
Countries
China
Contacts
Public ContactGu Liangyou
Chinese PLA General Hospital
Outcome results
None listed