[Translation] A single-arm, multi-center, open-label phase IIa clinical study evaluating the efficacy and safety of VG161 in the treatment of advanced bone and soft tissue sarcoma
主要目的:
评价VG161连续多次肿瘤内注射给药治疗标准治疗失败的骨与软组织肉瘤患者的有效性。
次要目的:
1) 评价VG161有效性的次要观察指标;
2) 监测药效学相关的免疫指标变化;
3) 对肿瘤组织活检样本进行相关病理学和免疫学特征评价;
4) 进一步评价 VG161的安全性和耐受性。
探索性目的:
1)初步分析Nanostring方法检测的免疫相关基因谱变化。
[Translation] main purpose:
To evaluate the effectiveness of continuous multiple intratumoral injections of VG161 in patients with bone and soft tissue sarcoma who failed standard treatment.
Secondary purpose:
1) Secondary observation indicators to evaluate the effectiveness of VG161;
2) Monitor changes in pharmacodynamic-related immune indicators;
3) Evaluate the relevant pathological and immunological characteristics of tumor tissue biopsy samples;
4) Further evaluate the safety and tolerability of VG161.
Exploratory purpose:
1) Preliminary analysis of changes in immune-related gene profiles detected by the Nanostring method.