Actively Recruiting
Study on the Efficacy of Neoadjuvant or Adjuvant Therapy Based on PD1 Inhibitors Combined With Clostridium Butyricum Supplementation for Urothelial Carcinoma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-11-20
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding Clostridium butyricum to anti-PD1 treatment can improve outcomes for patients with bladder cancer. This study focuses on patients receiving either neoadjuvant or adjuvant therapy to assess if this combination enhances treatment effectiveness and prolongs prognosis. The trial is a Phase 2, double-blind, randomized study sponsored by The First Affiliated Hospital with Nanjing Medical University. Participants in the neoadjuvant therapy group receive three cycles of gemcitabine and cisplatin combined with tislelizumab (an anti-PD1 drug) every 21 days, with some also taking Clostridium butyricum tablets twice daily. The adjuvant therapy group receives tislelizumab every 21 days for one to two years, with or without Clostridium butyricum supplementation. The study compares these two treatment approaches to see which offers better outcomes. During the study, participants are monitored for progression-free survival and overall survival up to three years after surgery. Researchers will evaluate the effectiveness of the treatments through regular assessments, including clinical observations and follow-up visits. The total time commitment varies depending on therapy type and follow-up duration, with careful monitoring to track patient health and treatment response.
CONDITIONS
Brief Title
PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For neoadjuvant therapy: Patients with bladder cancer stages T2 to T4a without lymph node (N0) or distant (M0) metastasis
- For adjuvant therapy: Patients with postoperative pathological stage T3 to T4 and/or positive lymph node metastasis
- Adults aged 18 years or older
You will not qualify if you...
- Patients unable to tolerate radical surgery as evaluated by researchers
- Patients who have previously received systemic chemotherapy or immunotherapy
- Patients with active autoimmune diseases requiring systemic treatment or conditions needing long-term use of hormones or immunosuppressants
- Patients who had major surgery or major trauma within 28 days before joining the study
- Patients vaccinated with live vaccines within 28 days before joining the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Neoadjuvant therapy: 3 cycles of 21 days each; Adjuvant therapy: 1 to 2 years
Participants receive neoadjuvant or adjuvant therapy with PD1 inhibitors combined with or without Clostridium Butyricum tablets.
Every 21 days during treatment cycles
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
X
Xiao Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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