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

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining an immunotherapy drug (a PD-1 inhibitor) with a probiotic supplement (Clostridium butyricum) before or after bladder cancer surgery can improve outcomes for people with urothelial (bladder) carcinoma. **You may be eligible if...** - You have muscle-invasive bladder cancer (stage T2-T4a) with no lymph node or distant spread, and are being considered for pre-surgery treatment, OR - Your post-surgery pathology showed advanced stage (T3-T4) or positive lymph nodes **You may NOT be eligible if...** - Your surgeon determines you cannot safely undergo radical surgery - You have previously received chemotherapy or immunotherapy for this cancer - You have an active autoimmune disease requiring systemic treatment - You require long-term high-dose steroids or other immunosuppressive drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGClostridium Butyricum Tablets

Gemcitabine and Cisplatin combined with Clostridium Butyricum Tablets

DRUGCisplatin

Gemcitabine and Cisplatin


Locations(1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06696742


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