A Phase 2 interventional study of Clostridium Butyricum Tablets and Cisplatin in Bladder (Urothelial, Transitional Cell) Cancer, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment
This study intends to explore whether the combination of Clostridium butyricum can improve the current situation of poor anti-PD1 treatment effect in patients with bladder cancer.
This study intends to explore whether the combination of Clostridium butyricum can improve the current situation of poor anti-PD1 treatment effect in patients with bladder cancer.
This study is divided into two parts. One is the patients with neoadjuvant therapy. After 3 cycles of neoadjuvant therapy, to observe whether the patients with Clostridium butyricum live tablets have better neoadjuvant therapy efficacy. The other was in patients with adjuvant therapy to see if adjuvant therapy combined with Clostridium butyricum could prolong the patient's prognosis.
716 studies on the registry are indexed under Carcinoma, Transitional Cell; 201 are open to participants now.
This study's planned enrollment of 60 is above the median of 49 across 549 interventional studies indexed under Carcinoma, Transitional Cell.
Browse Carcinoma, Transitional Cell studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For Neoadjuvant therapy:
For Adjuvant therapy:
Exclusion Criteria:
For Neoadjuvant therapy * GC: gemcitabine (1.0 g/m2 on days 1 and 8) and cisplatin (70 mg/m2 evenly distributed over days 2 to 4) every 21 days for 3 cycles. * PD1: Tislelizumab 200mg every 21 days for 3 cycles. ③Clostridium butyricum: Clostridium Butyricum Tablets, 20mg, twice a day. For Adjuvant Therapy: ①PD1: Tislelizumab 200mg every 21 days for 1-2 year. ②Clostridium butyricum: Clostridium Butyricum Tablets, 20mg, twice a day.
Drug: Clostridium Butyricum Tablets
For Neoadjuvant therapy ①GC: gemcitabine (1.0 g/m2 on days 1 and 8) and cisplatin (70 mg/m2 evenly distributed over days 2 to 4) every 21 days for 3 cycles. ②PD1: Tislelizumab 200mg every 21 days for 3 cycles. For Adjuvant Therapy: ①PD1: Tislelizumab 200mg every 21 days for 1-2 year.
Drug: Cisplatin
Gemcitabine and Cisplatin combined with Clostridium Butyricum Tablets
Also known as: Cisplatin, Gemcitabine
Gemcitabine and Cisplatin
Also known as: Gemcitabine
PFS
Progression-Free Survival
Time frame: 3 years after surgery
OS
Overall Survival
Time frame: 3 years after surgery
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The First Affiliated Hospital with Nanjing Medical University