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NCT06696742RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 20 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
30 Oct 2024
Start date
1 Feb 2024
Primary completion date
1 Feb 2029
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
NCT number
NCT06696742

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From 1 Feb 2024 to the primary completion date, 1 Feb 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The researchers evaluated the patients who could not tolerate radical surgery;
  • Previously received systemic chemotherapy or immunotherapy;
  • 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.

Other illness

  • There are active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of a large number of hormones and other immunosuppressants;

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Nanjing Medical University
Coordinator of this site? Confirm its status
NanjingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.