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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC+anti-PD1+Clostridium butyricum | Experimental | For Neoadjuvant therapy
For Adjuvant Therapy: â‘ PD1: Tislelizumab 200mg every 21 days for 1-2 year. â‘¡Clostridium butyricum: Clostridium Butyricum Tablets, 20mg, twice a day. |
|
| GC+anti-PD1 | Active Comparator | For Neoadjuvant therapy â‘ 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. â‘¡PD1: Tislelizumab 200mg every 21 days for 3 cycles. For Adjuvant Therapy: â‘ PD1: Tislelizumab 200mg every 21 days for 1-2 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clostridium Butyricum Tablets | Drug | Gemcitabine and Cisplatin combined with Clostridium Butyricum Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-Free Survival | 3 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall Survival | 3 years after surgery |
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Inclusion Criteria:
For Neoadjuvant therapy:
For Adjuvant therapy:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Yang | Contact | +8613951813528 | yangxiao2915@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qiang Lu | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin | Drug | Gemcitabine and Cisplatin |
|
|
| D006571 |
| Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |