Combining Clostridium Butyricum with PD1 inhibitors for bladder cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of Clostridium butyricum in enhancing the response to anti-PD1 therapy in patients with bladder cancer. It is divided into two parts: one focusing on patients receiving neoadjuvant therapy to assess if Clostridium butyricum improves treatment efficacy after three cycles, and the other examining its impact on prognosis in patients undergoing adjuvant therapy. The study aims to provide insights into improving treatment outcomes for bladder cancer patients who currently have limited options.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Qiang Lu — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Xiao Yang
• Email: yangxiao2915@163.com
• Phone: +8613951813528

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.