Status:
ACTIVE_NOT_RECRUITING
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Lead Sponsor:
Sun Yat-sen University
Conditions:
Muscle-Invasive Bladder Carcinoma
Programmed Cell Death Protein 1 Inhibitor
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The goal of this Phase 2 trial is to evaluate a non-surgical bladder-preserving treatment mode which consists of neoadjuvant chemotherapy plus anti-programmed cell death protein 1 (anti-PD-1) therapy ...
Detailed Description
Bladder cancer is the second most common malignancies over the world. At initial diagnosis, the cases with muscle-invasive bladder cancer (MIBC) accounts nearly 20% of all bladder cancer patients. And...
Eligibility Criteria
Inclusion
- Pathologically diagnosed bladder malignant tumor via biopsy
- Urothelial carcinoma as the primary histological component
- Pretreatment clinical TNM stage as T2-4aN0M0 or T1-4aN1-2M0 (UICC TNM staging classification, version 8)
- Age between 18 and 75 years old
- Karnofsky performance score ≥ 70
- Creatinine clearance rate ≥ 30 ml/min
Exclusion
- Simultaneous tumors of the urethra or upper urinary tract
- Existence of small cell cancer component
- Uncontrolled tuberculosis, viral hepatitis or AIDS
- Autoimmune or mental diseases
- Severe cardiac, renal, hepatic or hematopoietic dysfunctions unsuitable for chemotherapy, radiotherapy or immune checkpoint inhibiting therapy
- Prior history of other malignancies within 5 years, except cured cervical carcinoma in situ and skin basal cell carcinoma
- Prior history of pelvic radiotherapy or chemotherapy
- Poor adherence to regular follow-up (cystoscopy, CT, MRI, etc.)
- Pregnant or lactating women
- Treatment with glucocorticoid or immunosuppressive drugs within 1 month
- Other situations for which the investigators consider a patient inappropriate to participate
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT05975307
Start Date
December 1 2023
End Date
December 31 2029
Last Update
December 1 2025
Active Locations (1)
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1
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060