多抗原自体免疫细胞注射液(MASCT-I)用于晚期尿路上皮癌受试者标准一线化疗获益后维持治疗的多中心、随机对照、II期临床研究
[Translation] A multicenter, randomized, controlled, phase II clinical study of multi-antigen autologous immune cell injection (MASCT-I) for maintenance treatment of advanced urothelial carcinoma patients after benefit from standard first-line chemotherapy
主要目的:评估接受标准一线化疗结束后临床获益的尿路上皮癌受试者使用MASCT-I+BSC 维持治疗较单采PBMC 细胞+BSC 对PFS 的改善情况;次要目的:评估MASCT-I+BSC 用于标准一线化疗结束后维持治疗的其他疗效指标,并进一步评估MASCT-I 用于这一人群的安全性。
[Translation] The primary objective is to evaluate the improvement in PFS of MASCT-I+BSC maintenance therapy compared with single-collected PBMC cells+BSC in subjects with urothelial carcinoma who have achieved clinical benefits after standard first-line chemotherapy. The secondary objective is to evaluate other efficacy indicators of MASCT-I+BSC for maintenance therapy after standard first-line chemotherapy, and further evaluate the safety of MASCT-I in this population.
100 Clinical Results associated with Hengruiyuanzheng (Shenzhen) Biotechnology Co., Ltd.
0 Patents (Medical) associated with Hengruiyuanzheng (Shenzhen) Biotechnology Co., Ltd.
100 Deals associated with Hengruiyuanzheng (Shenzhen) Biotechnology Co., Ltd.
100 Translational Medicine associated with Hengruiyuanzheng (Shenzhen) Biotechnology Co., Ltd.