Bladder cancer
Conditions
Interventions
Experimental group:5x5Gy combined with immunotherapy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the clinical observation, have the ability to choose treatment independently, and sign the written informed consent to participate in the clinical observation; 2. Male or female, who has reached the age of 18 on the date of signing the informed consent, and the maximum age does not exceed 85 years old; 3. Non myometrial invasive urothelial carcinoma confirmed by cystoscopy and histology; 4. High / very high risk NMIBC patients; 5. Willing to retain bladder, with good bladder function (bladder volume at least 300ml); 6. All patients must undergo complete TURBT and those with negative results of urine fish / urine exfoliated cells; 7. Sufficient functions of heart, bone marrow, liver, kidney and other organs: Neutrophils >= 1.5 x 10^9 /L Hemoglobin >= 9 g / dl (concentrated red blood cells were not infused within 2 weeks); Platelet >= 100 x 10^9 /L ALT = 50ml / min; Normal or abnormal coagulation function (PT, APTT, TT, FBG) has no clinical significance; 8. Life expectancy exceeds 12 months; 9. ECoG physical condition: 0 or 1 point; 10. Willing and able to follow the study and follow-up procedures.
Exclusion criteria
Exclusion criteria: Subjects must be excluded from the trial if they have any of the following conditions: 1. Patients who have received pelvic radiotherapy; 2. There are active or progressive infections requiring systematic treatment, such as active tuberculosis, active hepatitis, etc; 3. There are systematic diseases judged by researchers to be unstabilized, including diabetes, hypertension, cirrhosis and severe lung diseases; 4. Pregnant or lactating women; 5. Suffering from any other disease, metabolic abnormality, abnormal physical examination or abnormal laboratory examination, and according to the judgment of the investigator, it is reasonable to suspect that the patient has a disease or state that is not suitable for the use of the study drug, or will affect the interpretation of the study results, or put the patient at high risk; 6. It is estimated that the compliance of patients participating in this clinical study is insufficient; 7. After complete TURBT, the results of fish / Exfoliated Cells in urine were more than 2 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival;Safty; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactFeng Wen/Yali Shen
West China Hospital of Sichuan University
Outcome results
None listed