bladder cancer
Conditions
Interventions
experimental group:Neoadjuvant chemotherapy and immunotherapy before concurrent chemoradiotherapy and immunotherapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. They voluntarily participated in the clinical observation, had the ability to choose treatment independently, and signed the written informed consent to participate in the clinical observation; 2. Male or female, aged 18 or above on the day of signing the informed consent; 3. There were urothelial carcinoma confirmed by cystoscopy and evidence of myometrial invasion; (Note: if patients with special components are considered, such as vascular lymph infiltration, sarcomatoid differentiation, squamous cell carcinoma, etc.); Differentiation, adenoid differentiation, micropapillary differentiation, nestlike differentiation, plasmacytoid differentiation and neuroendocrine differentiation should be evaluated by experienced urologists. 4. T2 (multiple tumor, hydronephrosis, coexistence of multiple pathological types or high degree of malignancy) and t3-t4a / N0-2 patients with locally advanced MIBC were initially diagnosed (before neoadjuvant chemotherapy); 5. According to RECIST, the patients were divided into Cr, partial response (PR), stable disease (SD) and progress of disease, Patients with non PD who have strong desire to retain bladder or cannot accept radical surgery were included; 6. Sufficient function of heart, bone marrow, liver and kidney: Neutrophils >= 1.5x10^9/L; Hemoglobin >= 9 g/dl (concentrated red blood cells were not infused within 2 weeks); Platelets >= 100 x 10^9/L; Alt = 50ml/min; The coagulation function (PT, APTT, TT, FBG) was normal or abnormal without clinical significance; 7. Life expectancy over 12 months; 8. ECoG physical condition 0 or 1; 9. Willing and able to follow the study and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. After neoadjuvant chemotherapy combined with immunotherapy, there are serious complications that may affect the follow-up observation and treatment; 2. There are active or progressive infections that need systematic treatment, such as active tuberculosis, active hepatitis, etc; 3. There are systemic diseases which have not been controlled by researchers, including diabetes, hypertension, liver cirrhosis and severe lung diseases; 4. Pregnant or lactating women; 5. Suffering from any other disease, metabolic abnormality, abnormal physical examination or laboratory examination, according to the judgment of the researcher, it is reasonable to suspect that the patient has a disease or state unsuitable for the use of the study drug, or will affect the interpretation of the study results, or put the patient in a high-risk situation; 6. It is estimated that the compliance of patients participating in this clinical study is insufficient; 7. Neoadjuvant chemotherapy combined with immunotherapy was stopped for more than 2 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical complete remission rate, cCR;disease specific survival, DSS;disease free survival, DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, OS;Implementation rate of salvage surgery;loco-regional recurrence-free survival, LRFS;distant metastasis free survival, DMFS;functional assessment of Cancer therapy generic scale, FACT–G; | — |
Countries
China
Contacts
Public ContactShen Yali
West China Hospital, Sichuan University
Outcome results
None listed