RecruitingPhase 2NCT06696742

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

60 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Bladder (Urothelial, Transitional Cell) Cancer

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

For Neoadjuvant therapy:
T2-T4aN0M0 bladder patients
For Adjuvant therapy:
Postoperative pathological stage T3-T4 and/or lymph node metastasis were positive.

Exclusion Criteria5

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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