PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma

Phase 2

Recruiting

• Conditions: Bladder (Urothelial, Transitional Cell) Cancer
• Interventions: Drug: Clostridium Butyricum Tablets; Drug: Cisplatin

• Registration Number: NCT06696742
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Study Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2024-10-30
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-17
• Last Update Submitted: 2024-11-17
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Primary Completion: 2029-02-01
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

For Neoadjuvant therapy:

• T2-T4aN0M0 bladder patients

For Adjuvant therapy:

• Postoperative pathological stage T3-T4 and/or lymph node metastasis were positive.

Exclusion Criteria

• The researchers evaluated the patients who could not tolerate radical surgery;
• Previously received systemic chemotherapy or immunotherapy;
• There are active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of a large number of hormones and other immunosuppressants;
• Have had major surgery or major trauma within 28 days before joining the group;
• Vaccinated with live vaccine within 28 days before joining the group.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GC+anti-PD1+Clostridium butyricum	Clostridium Butyricum Tablets	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.
GC+anti-PD1	Cisplatin	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.

Primary Outcome Measures

Name	Time	Method
PFS	3 years after surgery	Progression-Free Survival

Secondary Outcome Measures

Name	Time	Method
OS	3 years after surgery	Overall Survival

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China