Urothelium carcinoma
Conditions
Interventions
Intervention group:RC48+radiotherapy
Sponsors
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Men or women aged >= 18 years old; 2. ECOG PS: 0-1 points; 3. The subjects need to undergo TURBT surgery or partial cystectomy and imaging diagnosis. The researchers have determined that there is muscle infiltrating bladder urothelial carcinoma (urothelial carcinoma is the main pathological component>50%), and plan to undergo radical cystectomy+lymph node dissection+urinary diversion surgery; 4. Clinical staging T2 (CT/MRI+PET/CT); 5. Residual tumor lesions after TURBT or partial cystectomy (determined by the researcher); 6. Tissue examination specimens with TURBT or partial cystectomy; 7. Expected survival time >= 3 months; 8. The immunohistochemical staining results of tissues after diagnostic TURBT or partial cystectomy are IHC 2+or 3+; 9. The main organ function is normal (14 days before enrollment), which meets the following criteria: (1) The blood routine examination standard should meet (no blood transfusion or granulocyte colony-stimulating factor treatment within 14 days before enrollment): HB >= 90 g/L; ANC >= 1.5 × 10^9/L; PLT = 100 × 10^9/L; (2) Non functional organic diseases must meet the following standards: T-BIL 30ml/min (Cockcroft Fault formula); 10. International standardized ratio (INR), activated partial thromboplastin time (aPTT): <= 1.5 × ULN (this standard is only applicable to patients who do not receive anticoagulant treatment; patients who receive anticoagulant treatment should keep Anticoagulant within the range of treatment requirements); 11. No systemic Corticosteroid treatment within 4 weeks before treatment; 12. Highly effective contraceptives (such as oral contraceptives, intrauterine devices, libido control or barrier contraceptives combined with Spermicide) must be used by men with reproductive capacity or women with the possibility of pregnancy during the test, and contraception should be continued for 12 months after the end of treatment; 13. The subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who have received other anti-tumor treatment (including Corticosteroid treatment and immunotherapy) or participated in other clinical studies within 4 weeks before the start of the study treatment, or have not recovered from the previous toxicity (except for degree 2 hair loss and degree 1 neurotoxicity); 2. Pregnant or lactating women; 3. Positive Diagnosis of HIV/AIDS; 4. Patients with active hepatitis B or C 5. HBsAg or HBcAb positive individuals simultaneously detected HBV DNA copy number positive (quantitative detection limit of 500IU/ml, or reaching the copy number positive value detected by the research center); HBV DNA must be tested for this type of patient during screening research; 6. Patients with positive HCV antibody test results can only be selected for this study if the PCR test result for HCV RNA is negative. 7. Have a clear history of active tuberculosis; 8. Active autoimmune diseases requiring systematic treatment in the past two years (such as the use of disease regulating drugs, Corticosteroid or immunosuppressive drugs), and relevant alternative treatment (such as Thyroxine, insulin, or physiological Corticosteroid alternative treatment of renal or pituitary insufficiency) is allowed; 9. Other serious and uncontrollable concomitant diseases that may affect the compliance of the scheme or interfere with the interpretation of the results, including active Opportunistic infection or progressive (serious) infection, uncontrollable diabetes Cardiovascular disease (Grade III or IV heart failure defined by the New York Heart Association classification, more than Grade II heart block, myocardial infarction, unstable arrhythmia or unstable angina pectoris in the past six months, cerebral infarction in three months, etc.) or pulmonary disease (interstitial pneumonia, obstructive pulmonary disease and symptomatic Bronchospasm history); 10. Those who have received live vaccination within 4 weeks before the start of treatment; 11. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 12. Excessive surgical procedures (excluding diagnostic surgeries) performed within 4 weeks prior to the start of treatment; Individuals who have a history of abuse of psychotropic substances and are unable to quit or have a history of mental disorders; Large amounts of pleural or ascitic fluid accompanied by clinical symptoms or requiring targeted treatment; 13. In the past 5 years, he has suffered from other malignant tumors that have not been cured, but does not include obviously cured malignant tumors or curable cancers, such as basal skin cancer or squamous cell skin cancer, localized low-risk prostate cancer, cervical Carcinoma in situ or breast Carcinoma in situ; Remarks: Localized low-risk prostate cancer (defined as patients with stage <= T2b, Gleason score <= 7, and PSA <= 20ng/mL (if measured) at the time of diagnosis of prostate cancer who have received radical Sex therapy and have no biochemical recurrence of prostate specific antigen (PSA) can participate in this study); 14. Combined upper urinary tract urothelial carcinoma (renal pelvis, ureter urothelial carcinoma) 15. According to the researcher's perspective, there may be increased risks associated with participating in the study, or other severe, acute, or chronic medical or mental illnesses or laboratory abnormalities that may interfere with the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bladder-intact event-free; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission rate;recurrence-free survival;overall survival;advers event ; | — |
Countries
China
Contacts
Public ContactXiaoping Zhang
Huazhong University of Science and Technology Tongji Medical College Affiliated
Outcome results
None listed