muscle-invasive bladder cancer
Conditions
Interventions
Observation group:JSKN003 combined with KN046 neoadjuvant therapy
Sponsors
harbin medical university cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 75 years on the date of signing the informed consent form, regardless of gender; 2. Pathologically diagnosed myometrial invasive bladder cancer (cT2-T4a, = N1, M0, tumor stage is subject to the eighth edition of the American Joint Commission on Cancer (AJCC) in 2017); 3. Patients who plan to undergo radical cystectomy; 4. ECOG score 0-1, estimated survival time>12 months; 5. Since the diagnosis of muscle invasive bladder cancer, the patient has not received anti-tumor system treatment; 6. The function of important organs is normal.There are a series of indicator standards; 7. Female subjects with fertility or male subjects whose partners have fertility agree to adopt highly effective contraceptive measures (with an annual failure rate of less than 1%) from the start of the first administration to 180 days after the end of administration.
Exclusion criteria
Exclusion criteria: 1. Previously received anti PD-1/PD-L1/CTLA-4 antibody therapy or systemic chemotherapy; 2.Received BCG infusion therapy within 4 weeks; 3. Previously received bladder radiation therapy; 4. Any history of active autoimmune diseases or autoimmune diseases; 5. Complex diseases that require the use of immunosuppressive drugs.Concurrent diseases require the use of immunosuppressive agents that can absorb corticosteroids throughout the body or locally (excluding hormone therapy with physiological replacement doses due to adrenal insufficiency). Within 2 weeks prior to the use of the investigational drug, the use of prednisone greater than 10 mg/day or equivalent amounts of other corticosteroids is prohibited; 6. Previously or currently suffering from interstitial pneumonia/lung disease that requires systemic hormone therapy, or suspected interstitial pneumonia/lung disease that cannot be ruled out by screening imaging examination; 7. Merge with other malignant tumors (Except for skin basal cell carcinoma, superficial bladder cancer carcinoma, skin squamous cell carcinoma, thyroid papillary carcinoma or cervical carcinoma in situ that have received radical treatment or other malignant tumors that have received radical treatment and have not recurred within 5 years of treatment); 8. History of allergies to other antibody drugs; 9. History of human immunodeficiency virus (HIV) infection; 10. The subject suffers from active infection, including active tuberculosis; 11. Concomitant severe cardiovascular diseases, such as the New York Heart Association (NYHA) (grade II or higher), myocardial infarction within the past 3 months, unstable arrhythmias, or unstable angina pectoris; 12. History of abuse, alcoholism, or drug use of psychotropic substances; 13.Research identifies other factors that may affect the safety of participants, such as severe laboratory test abnormalities, comorbidities requiring treatment, or other family and social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response;Pathological complete response;Events free survival;Drug safety; | — |
Countries
China
Contacts
Public ContactXu Wanhai
harbin medical university cancer hospital
Outcome results
None listed