bladder cancer
Conditions
Interventions
Treatment group:Systematic therapy with Gemcitabine and Cisplatin plus Anlotinib and Benmelstobart
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed, clinical stage T2-T4aN0M0 bladder urothelial cancer; 2. Tumor number =2; 3. Without multiple of diffused CIS; 4. Tumor size =6cm; 5. Radical TURBT: no visible residual tumor, random biopsy is negative; 6. No hydronephrosis; 7. Aged 18-75 years old, with life expectancy >2years, ECOG score 0-1; 8. Untolerable or refused to cystectomy and urinary diversion. 9. There are no significant abnormalities in the functions of the liver, kidneys, bone marrow, heart, and other important organs. Blood biochemical tests show that the levels of liver enzymes ALT, AST, and bilirubin do not exceed the high normal range; Glomerular filtration rate = 60mL/min; The levels of white blood cells and platelets are both higher than the low normal range, and hemoglobin is = 110g/L; There is no increase in myocardial enzymes or high-sensitivity troponin, and there is no myocardial ischemia or arrhythmia that requires treatment; 10. Able to understand this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Primary bladder non-urethelial carcinoma; 2. With upper tract urethelial carcinoma; 3. Metastatic disease (N+ or M+); 4. Concomitant other malignant tumors within 5 years prior to the first dose (except for local tumors that are considered cured or have a low risk of recurrence in evaluation of the investigator); History of prior treatment with T-cell costimulatory or immune checkpoint inhibitors; 5. Prior chemotherapy, small molecule targeted drug therapy, or radiotherapy; 6. Systemic corticosteroid treatment (= 10 mg/day) is required within 7 days prior to enrollment or during the study period; 7. With active autoimmune disease or immunodeficiency disease; 8. Undergone major surgical procedures within 4 weeks; 9. Cardiovascular and cerebrovascular diseases with clinical significance within 6 months before the first administration: myocardial infarction, severe/unstable angina, primary cardiomyopathy, cerebrovascular accident or congestive heart failure, etc; History of myocardial ischemia or coronary heart disease, or electrocardiogram indicating myocardial ischemia or arrhythmia, requiring medication treatment; Hypertension that is adequately treated with medication but not controlled (systolic blood pressure = 150mmHg, diastolic blood pressure = 100mmHg); 10. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS); 11. Active or chronic hepatitis B infection (positive for hepatitis B virus surface antibodies or core antibodies, with DNA>2000IU/mL or 10000 copies/mL) or hepatitis C infection (positive for hepatitis C virus antibodies and RNA>high normal range), tuberculosis infection, etc; 12. High risk of bleeding: (1) Long term use of oral anticoagulants, nonsteroidal anti-inflammatory drugs, or steroid drugs; (2) Spontaneous bleeding (or recurrent) requiring hospitalization or blood transfusion within 12 months; (3) Chronic bleeding constitution; (4) Cirrhosis with portal hypertension; (5) History of intracranial hemorrhage; (6) Known cerebral arteriovenous malformation; (7) had a stroke in the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bladder intact event free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical complete response;Understage rate;Metastasis free survival;Disease free survival;Overall survival;Adverse effeect rate; | — |
Countries
China
Contacts
Public ContactLiu Zhuowei
Sun Yat-sen University Cancer Center
Outcome results
None listed