Muscle Invasive Bladder Cancer
Conditions
Interventions
Treatment:Toripalimab Combined with Radiotherapy
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily sign the informed consent form and comply with the study protocol requirements. 2.Age >=18 years, regardless of gender. 3.Expected survival >=6 months. 4.Histologically confirmed urothelial carcinoma of the bladder, with or without mixed adenomatous or squamous differentiation. 5.Patients must have undergone radical cystectomy, performed via open, laparoscopic, or robotic approaches. The surgery must include standard bilateral pelvic lymph node dissection (PLND), preferably extending proximally from the mid-common iliac artery to the distal Cooper’s ligament, laterally to the genitofemoral nerve, and inferiorly to the obturator nerve. The method of urinary diversion is unrestricted. 6.Two patient cohorts are eligible: (1) Patients who received cisplatin-based neoadjuvant chemotherapy (NAC) must have post-NAC pathological staging of ypT2-4a and/or lymph node-positive (ypN+). (2) Patients who did not receive cisplatin-based NAC (due to refusal or ineligibility: eGFR =1.5 × 10?/L, platelets >=90 × 10?/L, hemoglobin >=90 g/L. (2)Liver: Total bilirubin 30 mL/min. (4)Cardiac: LVEF>=50% (confirmed by echocardiography). (5)Coagulation: INR <=1.5 × ULN and APTT <=1.5 × ULN (unless on therapeutic anticoagulation).
Exclusion criteria
Exclusion criteria: 1.Measurable disease per RECIST v1.1: Lymph nodes >15 mm in short axis on CT/MRI, or non-nodal lesions >10 mm in longest diameter. 2.Any severe or uncontrolled systemic condition per investigator assessment, including: Poorly controlled hypertension (SBP >180 mmHg or DBP >110 mmHg); Uncontrolled diabetes (HbA1c =8% within 3 months prior to treatment); Active bleeding manifestations. 3.Life expectancy 450 ms. 5. Active infections, defined as: HBV (HBsAg+ and HBV DNA >=2000 IU/mL, excluding drug-induced hepatitis); HCV (anti-HCV+ and HCV RNA+);HIV infection. 6.History of interstitial lung disease (ILD), severe COPD, severe pulmonary insufficiency, or symptomatic bronchospasm. 7.History of severe allergic dermatitis. 8.Grade >2 peripheral neuropathy. 9.Liver cirrhosis (decompensated Child-Pugh B/C). 10.Active autoimmune disease or history requiring immunosuppressants/systemic steroids (>10 mg/day prednisone equivalent within 2 weeks prior to enrollment). 11.Renal dysfunction (eGFR <30 mL/min). 12.Uncontrolled spinal cord compression requiring bone-stabilizing therapy 13.Prior pelvic/bladder radiotherapy. 14.Prior anti-PD-1/PD-L1 or CTLA-4 therapy (except PD-1 agents used with cisplatin in neoadjuvant setting). 15.Post-cystectomy adjuvant chemotherapy/radiotherapy for UC. 16.Other malignancies within 5 years, excluding: High-risk UTUC [(y)pT2-4a or (y)pN+]; Localized high-risk prostate cancer; Carcinoma in situ (cervix/breast), basal/squamous skin cancer, or radically treated DCIS without recurrence. 17.Other investigator-determined ineligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Disease-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;2-year Disease-Specific Survival;2-year Distant Metastasis-Free Survival; | — |
Countries
China
Contacts
Public ContactNan Liu
Chongqing University Cancer Hospital
Outcome results
None listed