Study on the Efficacy of Neoadjuvant or Adjuvant Therapy Based on PD1 Inhibitors Combined With Clostridium Butyricum Supplementation for Urothelial Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Neoadjuvant therapy:
- •T2-T4aN0M0 bladder patients
- •For Adjuvant therapy:
- •Postoperative pathological stage T3-T4 and/or lymph node metastasis were positive.
排除标准
- •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.
研究组 & 干预措施
GC+anti-PD1+Clostridium butyricum
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.
干预措施: Clostridium Butyricum Tablets (Drug)
GC+anti-PD1
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.
干预措施: Cisplatin (Drug)
结局指标
主要结局
PFS
时间窗: 3 years after surgery
Progression-Free Survival
次要结局
- OS(3 years after surgery)