Combining Clostridium Butyricum with PD1 inhibitors for bladder cancer treatment

Study on the Efficacy of Neoadjuvant or Adjuvant Therapy Based on PD1 Inhibitors Combined With Clostridium Butyricum Supplementation for Urothelial Carcinoma

This study is testing if adding Clostridium butyricum to PD1 inhibitors can help improve treatment results for bladder cancer patients.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06696742 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with T2-T4aN0M0 bladder cancer for neoadjuvant therapy or those with postoperative pathological stage T3-T4 and/or positive lymph node metastasis for adjuvant therapy.

Not a fit: Patients who have previously received systemic chemotherapy or immunotherapy, or those with active autoimmune diseases requiring systemic treatment, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment responses and survival rates for bladder cancer patients.

How similar studies have performed: While the combination of Clostridium butyricum with PD1 inhibitors is a novel approach, similar studies exploring immunotherapy enhancements have shown promising results.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu

• 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

Conditions Bladder Cancer