NCT06696742

PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma

Study on the Efficacy of Neoadjuvant or Adjuvant Therapy Based on PD1 Inhibitors Combined With Clostridium Butyricum Supplementation for Urothelial Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bladder (Urothelial, Transitional Cell) Cancer

Interventions

Type	Name	Description
DRUG	Clostridium Butyricum Tablets	Gemcitabine and Cisplatin combined with Clostridium Butyricum Tablets
DRUG	Cisplatin	Gemcitabine and Cisplatin

Timeline

• Start date: 2024-02-01
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2024-11-20
• Last updated: 2024-11-20

Locations

1 site across 1 country: China