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Recruiting NCT06696742

PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma

Phase II Interventional Bladder (Urothelial, Transitional Cell) Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clostridium Butyricum Tablets, Cisplatin.
Who it may be relevant to
Registry conditions: Bladder (Urothelial, Transitional Cell) Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Drug Clostridium Butyricum Tablets
    Gemcitabine and Cisplatin combined with Clostridium Butyricum Tablets
  • Drug Cisplatin
    Gemcitabine and Cisplatin

Primary outcome measures

  • PFS [Time frame: 3 years after surgery]
Secondary outcome measures (1)
  • OS [Time frame: 3 years after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Nanjing Medical University — Nanjing

Identifiers

NCT: NCT06696742 · 2024-SR-371

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗