Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma

Summary

The combination of immune checkpoint inhibitors (ICIs) plus angiogenesis inhibitors has demonstrated significant anti-tumor activity in certain cancer. The goal of this study was to evaluate the efficacy and safety of sintilimab (a human programmed death-1 ICI) plus anlotinib (a multi-target tyrosine kinase inhibitor, inhibiting tumor angiogenesis and proliferative signaling) in advanced non clear cell renal cell carcinoma.

Timeline

Start

2022-02-28

Primary completion

2024-11-13

Completion

2026-12-30

Publications

• Background 1. Bray F,Ferlay J,Soerjomatarm I,et al.Global cancer statistics 2018:GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J].CA Cancer J Clin,2018,68(6):394-424. 2. Choueiri T,Motzer R.Systemic therapy for metastatic renal-cell carcinoma[J].N Engl J Med,2017,376(4):354-366 3. ESCUDIER B,EISEN T,STADLER W M,et al.Sorafenib in advanced clear cell renal-cell carcinoma[J].N Engl J Med,2007,356(2):125-134 4. MOTZER R J,HUTSON T E,TOMCZAK P,et al.Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma[J].J Clin Oncol,2009,27(22):3584-3590 5. Armstrong AJ, Halabi S, Eisen T, et al. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial. Lancet Oncol. 2016;17(3):378-388. 6. Nizar M Tannir, Eric Jonasch, Laurence Albiges, et al. Everolimus Versus Sunitinib Prospective Evaluation in Metastatic Non-Clear Cell Renal Cell Carcinoma (ESPN): A Randomized Multicenter Phase 2 Trial[J]. European Urology, 2016, 69(5):866-874. 7. Motzer RJ, Barrios CH, Kim TM, et al.: Phase II randomized trial comparing sequential first-line everolimus and second-line sunitinib versus first-line sunitinib and secondline everolimus in patients with metastatic renal cell carcinoma. J Clin Oncol 2014; 32:2765-2772. 8. Zhou AP,Bai Y,Song Y,et al. Anlotinib Versus Sunitinib as First-Line Treatment for Metastatic Renal Cell Carcinoma:A Randomized PhaseⅡClinical Trial[J]. Oncologist,2019,24(8):e702-e708. DOI:10.1634/theoncologist.2018-0839. 9. CHOUEIRI T K,FISHMAN M N,ESCUDIER B,et al.Immunomodulatory activity of nivolumab in metastatic renal cell carcinoma[J].Clin Cancer Res,2016,22(22):5461-5471. 10. MCDERMOTT D F,SOSMAN J A,SZNOL M,et al.Atezolizumab,an antiprogrammed death-ligand 1 antibody,in metastatic renal cell carcinoma:long-term safety,clinical activity,and immune correlates from a phase Ⅰa study[J].J Clin Oncol,2016,34(8):833-842. 11. Rini, BI; Plimack, ER; Stus, V; et al.Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma.[J].N Engl J Med.2019,380(12):1116-1127 12. YASUDA S,SHO M,YAMATO I,et al.Simultaneous blockade of programmed death 1 and vascular endothelial growth factor receptor 2 (VEGFR2) induces synergistic anti-tumour effect in vivo[J].Clin Exp Immunol,2013,172:500-506

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