RECRUITINGPhase 2INTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
For Neoadjuvant therapy:
- T2-T4aN0M0 bladder patients
For Adjuvant therapy:
- Postoperative pathological stage T3-T4 and/or lymph node metastasis were positive.
Who Should NOT Join This Trial:
- The researchers evaluated the patients who could not tolerate radical surgery;
- Previously received systemic chemotherapy or immunotherapy;
- There are active autoimmune conditions (where your immune system attacks your own body)s 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Clostridium Butyricum Tablets
Gemcitabine and Cisplatin combined with Clostridium Butyricum Tablets
DRUG
Cisplatin
Gemcitabine and Cisplatin
Locations (1)
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China