Urothelial carcinoma
Conditions
Interventions
Treatment Group:Aiparolito Wurli Monoclonal Antibody Injection QL1706
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in clinical research; fully understand and be informed about this study and sign the informed consent form; willing to follow and capable of completing all trial procedures; 2. Age 18-80 years; 3. Histopathologically confirmed locally advanced or metastatic urothelial carcinoma (originating from bladder, ureter, renal pelvis, or urethra); subjects with urothelial carcinoma with squamous differentiation or mixed cell types still meet the inclusion criteria; 4. Subjects have radiologically confirmed metastatic or locally advanced disease at baseline. Among them, patients with locally advanced disease are unable to undergo resection with curative intent according to the treating physician's opinion; 5. The subject has received treatment with immune checkpoint inhibitors and platinum-based chemotherapy (cisplatin or carboplatin) during or after the diagnosis of locally advanced or metastatic disease; and the disease progressed (confirmed by imaging) during or within 6 months after the last treatment; treatment with =6 months; 8. Organ function and hematopoietic function must meet the following requirements: Hemoglobin (HGB) >= 70 g/L; White blood cell count (WBC) >= 3 × 10^9/L; Absolute neutrophil count (ANC) >= 1.5 × 10?/L; Platelet count (PLT) >= 80 × 10?/L; Total bilirubin (TBIL) =50 mL/min; International normalized ratio (INR) or prothrombin time (PT) <=1.5 × ULN; 9. For female patients of childbearing potential who are not surgically sterile, two medically approved contraceptive methods (such as intrauterine devices, contraceptive pills, or condoms) must be used during the study treatment period and for 6 months after the end of the study treatment period; female patients of childbearing potential who are not surgically sterile must have a negative serum HCG test within 72 hours before the first dose and must not be breastfeeding; for male patients with partners of childbearing potential, two effective contraceptive methods should be used during the study treatment period and for 6 months after the end of the study treatment period; 10. The subject agrees not to participate in any other interventional studies during their participation in this study treatment; 11. The subject voluntarily agrees and is able to comply with the trial protocol and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. The subject has any active autoimmune disease or a history of autoimmune disease; 2. Patients who have experienced >= Grade 3 immune-related adverse events; 3. The subject has a known hypersensitivity to the investigational drug or any excipient contained in the investigational drug formulation; 4. The lesion is amenable to radical resection and the patient can tolerate radical surgery; 5. The patient has participated or is currently participating in other clinical studies related to urothelial carcinoma; 6. Patients with severe medical conditions, such as severe infections, uncontrolled diabetes, cardiovascular diseases (Class III or IV heart failure as defined by the New York Heart Association classification, second-degree or higher heart block, myocardial infarction within the past 1 month, unstable arrhythmias or unstable angina, cerebral infarction within 1 month, etc.), or severe pulmonary diseases (interstitial pneumonia, severe obstructive pulmonary disease, and a history of symptomatic bronchospasm), or a history of clinically significant liver, kidney, hematological, endocrine, or neuropsychiatric diseases; 7. Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; physiological doses of glucocorticoids (<=10 mg/day of prednisone or equivalent) are permitted; 8. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV1/2 antibodies); 9. Untreated active hepatitis B; however, subjects with hepatitis B who meet the following criteria are also eligible for enrollment (HBV viral load must be <1000 copies/ml (200 IU/ml) before the first dose, and subjects should receive anti-HBV treatment throughout the study chemotherapy period to prevent viral reactivation. For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV treatment is not required, but close monitoring for viral reactivation is necessary); 10. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the detection limit); 11. Receipt of a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1) (Note: Inactivated influenza vaccines for seasonal influenza are allowed within 30 days before the first dose, but live attenuated influenza vaccines administered intranasally are not permitted); 12. Concurrent other active cancer, or a history of other malignant tumors within the past five years. Exceptions include: 1. Cured non-melanoma skin cancer; 2. Cured tumors: including cervical carcinoma in situ, superficial bladder cancer; 3. Other solid tumors that have received curative treatment, with no recurrence or metastasis for 5 years or more; 13. History of definite neurological or psychiatric disorders, such as epilepsy or dementia, or poor compliance; 14. History of drug abuse or substance abuse; 15. Other severe, acute, or chronic diseases or abnormal laboratory findings that may increase the risk of participation in the study and study drug use, or may interfere with the interpretation of study results; 16. Pregnant or lactating women; 17. The investigator determined the subject was unsuitable for participation in this study due to other reasons;
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| safety;Overall Survival;Progression Free Survival; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactKai Yao
Sun Yat-sen University Cancer Center
Outcome results
None listed