A Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Study of Anti-pd-l1 Monoclonal Antibody Injection (ZKAB001) Combined Albumin Binding Paclitaxel, Cisplatin in Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- major pathologic response rate
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled Ib/Ⅱ clinical study to evaluate the safety and effect of anti-PD-L1 antibody (ZKAB001) in neoadjuvant chemotherapy of esophageal squamous carcinoma in combination with Alb-paclitaxel and cisplatin. The immunotherapy will be given before and after the operation every three weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PD-L1 group
All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
干预措施: anti-PD-L1 antibody (Drug)
PD-L1 group
All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
干预措施: albumin bound paclitaxel (Drug)
PD-L1 group
All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
干预措施: cisplatin (Drug)
PD-L1 group
All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
干预措施: radical resection of esophageal carcinoma (Procedure)
placebo group
All patients will receive 4 cycles of placebo ( IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
干预措施: albumin bound paclitaxel (Drug)
placebo group
All patients will receive 4 cycles of placebo ( IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
干预措施: cisplatin (Drug)
placebo group
All patients will receive 4 cycles of placebo ( IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
干预措施: placebo (Drug)
placebo group
All patients will receive 4 cycles of placebo ( IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
干预措施: radical resection of esophageal carcinoma (Procedure)
结局指标
主要结局
major pathologic response rate
时间窗: Two weeks after surgery.
The rate of pathologic 1a and 1b after neoadjuvant chemotherapy.
次要结局
- overall survival rate(From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.)
- overall survival(From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.)
- R0 resection rate(Two weeks after surgery.)
- pathological complete response rate(Two weeks after surgery.)
- disease free survival(From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.)
- disease free survival rate(From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.)
- event free survival(From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.)
- event free survival rate(From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.)
- adverse events rate(From the date of randomization to 90 days after the last chemotherapy.)