Clinical trial · Interventional
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
NCT06696742CI-TRIAL-00082801recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder (Urothelial, Transitional Cell) Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Clostridium Butyricum Tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GC+anti-PD1+Clostridium butyricum
- description
- For Neoadjuvant therapy * GC: gemcitabine (1.0 g/m2 on days 1 and 8) and cisplatin (70 mg/m2 evenly distributed over days 2 to 4) every 21 days for 3 cycles. * PD1: Tislelizumab 200mg every 21 days for 3 cycles. ③Clostridium butyricum: Clostridium Butyricum Tablets, 20mg, twice a day. For Adjuvant Therapy: ①PD1: Tislelizumab 200mg every 21 days for 1-2 year. ②Clostridium butyricum: Clostridium Butyricum Tablets, 20mg, twice a day.
- interventionNames
- Drug: Clostridium Butyricum Tablets
- type
- ACTIVE_COMPARATOR
- label
- GC+anti-PD1
- description
- For Neoadjuvant therapy ①GC: gemcitabine (1.0 g/m2 on days 1 and 8) and cisplatin (70 mg/m2 evenly distributed over days 2 to 4) every 21 days for 3 cycles. ②PD1: Tislelizumab 200mg every 21 days for 3 cycles. For Adjuvant Therapy: ①PD1: Tislelizumab 200mg every 21 days for 1-2 year.
- interventionNames
- Drug: Cisplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.