Bladder Cancer
Conditions
Interventions
Experimental group:Palliative laser therapy combined with adebrelimab
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in this study, can understand the research content, and have signed a written informed consent form approved by the ethics committee; 2. Age =70 years, any gender; 3. Urothelial carcinoma confirmed by pathology or cytology, with the primary site in the bladder; 4. Clinical stage of locally invasive bladder cancer (cT2–T4, N0–1, M0); 5. Assessed by a multidisciplinary team (MDT) as unsuitable for or unable to tolerate radical surgery or chemoradiotherapy; 6. Past or present bladder tumor-related symptoms (such as gross hematuria, obstruction, or urinary retention) requiring transurethral laser palliative treatment; 7. ECOG performance status score of 0–2; 8. Expected survival >=12 weeks; 9. At least one evaluable local bladder lesion or clear evidence of clinical tumor activity; 10. Major organ function is basically normal and meets the following laboratory test requirements (within 7 days during the screening period): (1) Complete Blood Count: 1) Neutrophil count >= 1.5×10^9/L 2) Platelet count >= 100×10^9/L 3) Hemoglobin >= 90 g/L (transfusion before screening is allowed) (2) Liver Function: 1) ALT, AST = 50 mL/min (Cockcroft–Gault formula) 11. Subjects of reproductive potential agree to use effective contraception during the study and for at least 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. History of or current distant metastatic disease (M1); 2. Prior treatment with immune checkpoint inhibitors, including but not limited to PD-1, PD-L1, or CTLA-4 inhibitors; 3. Received other anti-tumor systemic therapy (including chemotherapy, targeted therapy, or other immunotherapy) within the past 4 weeks, or not yet recovered from previous treatment-related toxicities to 10 mg/day) or other immunosuppressive drugs (within 14 days before study administration); 7. Presence of active, uncontrolled infections, including but not limited to active tuberculosis; hepatitis B (HBsAg positive and HBV DNA positive), hepatitis C (HCV RNA positive), or human immunodeficiency virus (HIV) infection that are uncontrolled; 8. Presence of severe cardiovascular, pulmonary, hepatic, renal, or neurological disease that, in the investigator’s opinion, may affect study treatment tolerance or compliance; 9. History or coexistence of other malignancies not in complete remission or curatively treated within the past 5 years; exceptions include: cured non-melanoma skin cancer, carcinoma in situ, or other malignancies that have been curatively treated and recurrence-free for 5 years; 10. Known history of severe allergic reactions to adebrelimab or any of its components; 11. Presence of active central nervous system metastases or carcinomatous meningitis; 12. Presence of severe mental illness, cognitive dysfunction, or other conditions that, in the investigator’s opinion, would prevent understanding of the study or completion of follow-up; 13. Women who are pregnant or breastfeeding, or women of childbearing potential unwilling to use effective contraception; 14. Other conditions deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 8 weeks Bladder Event-Free Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactQiang Lv
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed