Status:
RECRUITING
Pilot Study on Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) as Neoadjuvant Therapy for Platinum-refractory Muscle-invasive Bladder Cancer
Lead Sponsor:
First Affiliated Hospital of Chongqing Medical University
Conditions:
Muscle Invasive Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This trial aims to evaluate the efficacy, safety, and biological mechanisms of rutin combined with tislelizumab and GC(Gemcitabine and Cisplatin) in platinum-refractory muscle-invasive bladder cancer ...
Eligibility Criteria
Inclusion
- Patients with cT2-cT4N0M0 muscle-invasive bladder cancer (MIBC)
- No response after 2 cycles of GC neoadjuvant chemotherapy
- No prior use of systemic immunotherapy or target therapy
- Tumor is measurable according to New response evaluation criteria in solid tumours: Revised RECIST guideline
- ECOG (ZPS, 5-point scale) 0-1
Exclusion
- Age less than 18 years
- Patients with severe cardiac, cerebral, hepatic, or renal disease
- Severely malnourished patients
- Patients with mental illness and those without insight and unable to express exactly
- Combined with malignant tumors of other organs
- Systemic infectious diseases
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 20 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06916494
Start Date
May 1 2025
End Date
January 20 2026
Last Update
April 10 2025
Active Locations (1)
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1
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China