Muscle-Invasive Bladder Cancer (MIBC)
Conditions
Interventions
Single arm:The corresponding drug therapy administered based on the results of patient-derived tumor-like cell clusters (PTC) drug sensitivity screening
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years; 2.Pathologically confirmed bladder cancer with clinical stage cT2-T4a N0 M0 muscle-invasive bladder cancer (MIBC); 3.Small tumor burden (e.g., unifocal tumor diameter <7 cm), absence of extensive carcinoma in situ (CIS) or multifocal lesions, no or unilateral hydronephrosis, and adequate bladder function; 4.At least one measurable lesion (per RECIST v1.1 criteria); 5.Effective contraception for subjects of childbearing potential; 6.Sufficient fresh tissue specimens obtainable via routine clinical procedures for cell culture; 7.No prior history of other malignancies, or history of malignancies with favorable prognosis (e.g., cutaneous basal cell carcinoma); 8.ECOG performance status <=2; 9.Voluntary participation with signed informed consent, good compliance, and willingness to follow up.
Exclusion criteria
Exclusion criteria: 1.Participation in other clinical trials within 6 months; 2.Major non-bladder cancer-related surgery recently, or incomplete recovery from such procedures; 3.Pregnancy, lactation, or unwillingness to use effective contraception during treatment for subjects of childbearing potential; 4.Large tumor burden (tumor diameter >=7 cm), presence of extensive carcinoma in situ (CIS) or multifocal lesions, bilateral hydronephrosis, or poor bladder function 5.Severe comorbidities interfering with the treatment plan; 6.Severe hepatic or renal dysfunction precluding chemotherapy tolerance; 7.Cognitive impairment, psychiatric disorders, or poor compliance; 8.Hypersensitivity to known components of chemotherapy, targeted therapy, or immunotherapy drugs; 9.Other conditions deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Complete Response (cCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year Bladder Preservation Rate; | — |
Countries
China
Contacts
Public ContactShen Bing
Shanghai Tenth People's Hospital
Outcome results
None listed