评价MASCT-I联合多柔比星和异环磷酰胺一线治疗晚期软组织肉瘤患者的有效性和安全性的随机对照、多中心Ⅱ期临床研究
[Translation] A randomized, controlled, multicenter phase II clinical study to evaluate the efficacy and safety of MASCT-I combined with doxorubicin and ifosfamide as first-line treatment for patients with advanced soft tissue sarcoma
主要目的:评估MASCT-I联合多柔比星及异环磷酰胺标准一线化疗对晚期软组织肉瘤受试者的有效性;次要目的:评估MASCT-I联合多柔比星及异环磷酰胺标准一线化疗对晚期软组织肉瘤受试者的安全性和其他疗效指标。
[Translation] The primary objective is to evaluate the effectiveness of MASCT-I combined with standard first-line chemotherapy with doxorubicin and ifosfamide in subjects with advanced soft tissue sarcoma. The secondary objective is to evaluate the safety and other efficacy indicators of MASCT-I combined with standard first-line chemotherapy with doxorubicin and ifosfamide in subjects with advanced soft tissue sarcoma.
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.
单中心,I期临床研究,评价多抗原自体免疫细胞注射液(MASCT-I)对晚期实体瘤患者的安全性和耐受性
[Translation] A single-center, phase I clinical study evaluating the safety and tolerability of multi-antigen autologous immune cell injection (MASCT-I) in patients with advanced solid tumors
主要目的: MASCT-I对晚期转移或复发且各种标准治疗失败的实体瘤患者的安全性和耐受性。 次要目的:MASCT-I给药后的免疫响应。 探索性目的: 初步探索MASCT-I的疗效。
[Translation] Primary objective: To investigate the safety and tolerability of MASCT-I in patients with solid tumors that have advanced metastatic or recurrent disease and have failed various standard treatments. Secondary objective: To investigate the immune response after administration of MASCT-I. Exploratory objective: To preliminarily explore the efficacy of MASCT-I.
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