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项目名称:重组PD-L1/TGF-βRII双功能融合蛋白SHR-1701单药或联合化疗治疗不可切除的III期非小细胞肺癌的开放性、多中心II期临床研究
PI:吴一龙教授
主要终点: SHR-1701单药或者联合化疗诱导治疗后的客观缓解率;18个月EFS率
次要终点: OS,TDDM, EFS, 安全性终点
探索性终点:PK,ADA,MPR(仅手术),生物标志物
Zhou Q, Pan Y, Yang X, Zhao Y, Han G, Pang Q, Zhang Z, Wang Q, Yao J, Wang H, Yang W, Liu B, Chen Q, Du X, Cai K, Li B, Huang Y, Li X, Song L, Shi W, Wu YL. Neoadjuvant SHR-1701 with or without chemotherapy in unresectable stage III non-small-cell lung cancer: A proof-of-concept, phase 2 trial. Cancer Cell. 2024 Jun 11:S1535-6108(24)00192-2. doi: 10.1016/j.ccell.2024.05.024. Epub ahead of print. PMID: 38906157.
Neoadjuvant SHR-1701 with or without chemotherapy in unresectable stage III non-small-cell lung cancer: A proof-of-concept, phase 2 trial - ScienceDirect 全文
Neoadjuvant SHR-1701 with or without chemotherapy in unresectable stage III non-small-cell lung cancer: A proof-of-concept, phase 2 trial - PubMed (nih.gov)
Pan Y, Yang X, Zhou Q, Zhao Y, Han G, Pang Q, Zhang Z, Wang Q, Yao J, Wang H, Yang W, Liu B, Chen Q, Du X, Cai K, Li B, Huang Y, Li X, Jia Y, Song L, Shi W, Wu YL. Neoadjuvant retlirafusp alfa (anti-PD-L1/TGF-β bifunctional fusion protein) with or without chemotherapy in unresectable stage III non-small cell lung cancer: updated results from the phase 2 TRAILBLAZER trial. Signal Transduct Target Ther. 2026 Jun 16;11(1):239. doi: 10.1038/s41392-026-02779-1. PMID: 42303632; PMCID: PMC13272590.
Neoadjuvant retlirafusp alfa (anti-PD-L1/TGF-β bifunctional fusion protein) with or without chemotherapy in unresectable stage III non-small cell lung cancer: updated results from the phase 2 TRAILBLAZER trial - PMC
Pan, Y., Yang, X., Zhou, Q. et al. Neoadjuvant retlirafusp alfa (anti-PD-L1/TGF-β bifunctional fusion protein) with or without chemotherapy in unresectable stage III non-small cell lung cancer: updated results from the phase 2 TRAILBLAZER trial. Sig Transduct Target Ther 11, 239 (2026). https://doi.org/10.1038/s41392-026-02779-1
https://www.nature.com/articles/s41392-026-02779-1.pdf
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