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NCT Number: NCT06696742

PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clostridium Butyricum Tablets

Drug

Gemcitabine and Cisplatin combined with Clostridium Butyricum Tablets

Other names: Cisplatin, Gemcitabine

Cisplatin

Drug

Gemcitabine and Cisplatin

Other names: Gemcitabine

Primary outcomes

  1. PFS

    Time frame: 3 years after surgery

    Progression-Free Survival

Secondary outcomes

  1. OS

    Time frame: 3 years after surgery

    Overall Survival

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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