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PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma

PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma

Recruiting
18 years and older
All
Phase 2

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Overview

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.

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.

Eligibility

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 details
    Bladder (Urothelial
    Transitional Cell) Cancer

NCT06696742

The First Affiliated Hospital with Nanjing Medical University

16 October 2025

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