Metastatic urothelial carcinoma
Conditions
Interventions
Experimental group:Based on the drug sensitivity results of organoid models, combined with clinical experience and patient conditions, a treatment plan is selected.
Sponsors
The First Affiliated Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 75, both male and female, are eligible; 2. Patients with urothelial carcinoma confirmed by histopathology and/or cytology, mainly including bladder cancer, ureteral cancer, and renal pelvis cancer; patients with mixed histological types (excluding small cell or neuroendocrine carcinoma), if urothelial carcinoma is the main tumor component, are eligible to participate in the study; 3. Patients with local or distant metastasis confirmed by imaging, and with measurable lesions according to RECIST 1.1 criteria; 4. Disease progression occurs after one systemic treatment (ADC combined with immunotherapy is considered as first-line treatment, and neoadjuvant/adjuvant therapy during the perioperative period is also considered as first-line treatment, provided that it has been more than one year since the end of the last medication); 5. Primary or metastatic lesions (such as soft tissue lesions, lymph nodes, etc.) can be resected or biopsied to obtain sufficient fresh tissue specimens for organoid establishment; 6. ECOG score is 0-2; 7. The estimated survival period is >= 3 months; 8. The patient voluntarily joined this study, signed the Informed Consent Form (ICF), exhibited good compliance, and cooperated with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Women during pregnancy and lactation; 2. Patients who have had clinically significant (i.e., active) heart disease (such as congestive heart failure, symptomatic coronary artery disease, arrhythmias, etc.) or myocardial infarction within the past 12 months; patients who have had renal vein thrombosis or non-embolic conditions within the past 6 months; or patients with cardiovascular diseases that the investigator deems to have significant clinical implications. 3. Patients with a history of abuse of psychotropic drugs who are unable to quit or those with mental disorders; 4. Patients who have developed other malignant tumors within 5 years, except for cured skin cancer; 5. Within the 4 weeks prior to enrollment, there was known uncontrolled active bacterial, viral, fungal, mycobacterial, parasitic infection or other infections (excluding onychomycosis) or any significant systemic infection event requiring intravenous antibiotic treatment or hospitalization (excluding neoplastic fever); 6. Patients with brain metastasis; 7. Patients who have not recovered from the toxicity associated with first-line treatment (<=Grade 1); 8. Other patients deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Overall Survival; | — |
Countries
China
Contacts
Public ContactJiang Junhui
The First Affiliated Hospital of Ningbo University
Outcome results
None listed