bladder cancer
Conditions
Interventions
Drug therapy group:treat with Disitamab Vedotin
Sponsors
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older; 2. Expected survival >= 3 months; 3. The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1; 4. Patients with clinical diagnosis of muscle-invasive bladder cancer (cT2-T4aN0M0 or cT1-T4aN1M0), no lymph node metastases at N2 or above, no distant metastases; 5. Histopathologically confirmed urothelial carcinoma of the bladder, mixed carcinoma requiring the urothelial carcinoma subtype as the predominant histological type, with immunohistochemical HER2 expression of 2+ or above; 6. Subjects who refuse or do not tolerate cisplatin-based neoadjuvant chemotherapy. Patients who meet one of the following criteria are not eligible for cisplatin treatment: (1) Impaired renal function with CrCl at 30 mL/min to 59 mL/min (according to the Cockcroft-Gault formula); (2) An ECOG status score of 2; (3) CTCAE grade 2 or above hearing impairment; (4) Based on clinical judgment, the potential risks of receiving cisplatin-based neoadjuvant chemotherapy outweigh the benefits; 7. Suitable and planned radical cystectomy (according to the guidelines); 8. The following hematological examination requirements and organ function level should be met before enrollment (based on the normal value of the study center): (1) Hemoglobin >= 9 g/dL; (2) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; (3) Platelets >= 100 x 10^9/L; (4) Serum total bilirubin = 30 mL/min (according to the Cockcroft-Gault's formula); (6) International normalized ratio (INR) = 12 months, no cause other than menopause has been found), and has not undergone sterilization (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy); 10. Men with a partner of reproductive age must agree to abstain from sex or use a reliable and effective method of contraception from the date of signing the informed consent until at least 180 days after the final dose of the study drug. Male subjects also had to agree not to donate sperm during the same time period. Male subjects whose partners are already pregnant are required to use condoms and do not need to use other methods of contraception; 11. Subjects are able and willing to comply with protocols for visits, treatment plans, laboratory tests, and other study-related procedures, and can sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. A history of malignancies other than urothelial bladder cancer in the 5 years prior to initial administration, except those that are curable and have a negligible risk of metastasis or death (such as adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, or surgically treated and curable ductal carcinoma in situ of the breast); 2. Evidence of distant lymph node or distant organ metastasis; 3. There are serious concomitant conditions that may interfere with the interpretation of the results or affect compliance with the clinical study, including severe liver disease (e.g., cirrhosis), severe epilepsy, or superior vena cava syndrome; 4. Pregnant and/or lactating women. Women who had a positive pregnancy test in the 2 weeks prior to initial administration; 5. Severe cardiovascular disease, such as acute myocardial infarction within 3 months prior to enrollment, cardiac function grade II or above (NYHA grade), unstable angina pectoris, or severe arrhythmia; 6. Severe infections within 4 weeks prior to enrollment, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia; 7. Had undergone major surgical procedures (excluding transurethral resection of bladder tumors) within 4 weeks prior to enrollment, or expected to undergo elective major surgical procedures other than diagnosis during the course of the study; 8. Severe allergic reaction to other monoclonal antibodies; 9. Test positive for HIV; 10. Uncontrollable infectious hepatitis; 11. Active tuberculosis; 12. Vaccination is not recommended within 4 weeks prior to enrollment or during the study period. The investigator may decide whether to allow subjects to be vaccinated during this period based on the clinical situation; 13. Participated in other drug clinical trials within 4 weeks prior to enrollment; 14. Systemic antitumor therapy was given within 4 weeks prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological down-staging rate ( <= pT1N0M0);Disease-free survival;Overall survival;12-month survival rate; | — |
Countries
China
Contacts
Public ContactHuang Houfeng
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Outcome results
None listed