[Translation] A randomized, double-blind, parallel-controlled phase III study of BC001 combined with paclitaxel versus placebo combined with paclitaxel in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line standard treatment
1、主要目的:评价BC001联合紫杉醇对比安慰剂联合紫杉醇在一线标准治疗失败的胃或胃食管结合部腺癌患者的总生存期(OS)。
2、 次要目的(1)评价 BC001 联合紫杉醇对比安慰剂联合紫杉醇在一线标准治疗失败的胃或胃食管结合部腺癌患者的无进展生存期(PFS)、客观缓解率(ORR)、缓解持续时间(DOR)、疾病控制率(DCR)、至治疗失败时间(TTF)、患者自我报告结局(PRO);(2)评价 BC001 联合紫杉醇对比安慰剂联合紫杉醇在一线标准治疗失败的胃或胃食管结合部腺癌患者的安全性特征;
(3)评价 BC001 联合紫杉醇对比安慰剂联合紫杉醇在一线标准治疗失败的胃或胃食管结合部腺癌患者的免疫原性特征。
(4)基于群体药代动力学(PopPK)分析方法,评价 BC001 的 PK特征。(5)探索 BC001 的暴露与效应之间的关系。
[Translation] 1. Main purpose: To evaluate the overall survival (OS) of BC001 combined with paclitaxel compared with placebo combined with paclitaxel in patients with gastric or gastroesophageal junction adenocarcinoma who failed first-line standard treatment.
2. Secondary objectives (1) To evaluate the progression-free survival (PFS), objective response rate (ORR), and duration of response of BC001 combined with paclitaxel compared with placebo combined with paclitaxel in patients with gastric or gastroesophageal junction adenocarcinoma who failed first-line standard treatment. Time (DOR), disease control rate (DCR), time to treatment failure (TTF), patient self-reported outcome (PRO); (2) To evaluate BC001 combined with paclitaxel versus placebo combined with paclitaxel in first-line standard treatment failure of stomach or gastroesophageal Safety profile in patients with junctional adenocarcinoma;
(3) To evaluate the immunogenicity characteristics of BC001 combined with paclitaxel versus placebo combined with paclitaxel in patients with gastric or gastroesophageal junction adenocarcinoma who failed first-line standard treatment.
(4) Based on the population pharmacokinetic (PopPK) analysis method, evaluate the PK characteristics of BC001. (5) To explore the relationship between exposure and effect of BC001.