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.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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.

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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.

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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