Drug intelligence / Profile preview

anlotinib hydrochloride + sintilimab + gemcitabine + cisplatin

Development stage
Phase 2
Lead developer
Zhejiang Province Cancer Hospital
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Oral, Intravenous
01

Overview

This combination therapy, often referred to as the SAGC regimen, is a multi-modality treatment being evaluated for advanced biliary tract cancer. It consists of **anlotinib hydrochloride**, an oral small-molecule multi-target tyrosine kinase inhibitor that inhibits VEGFR1/2/3, FGFR1-4, PDGFRα/β, and c-Kit; **sintilimab**, a humanized monoclonal antibody targeting the programmed cell death protein 1 (PD-1) receptor to enhance anti-tumor immune responses; and the standard chemotherapy doublet of **gemcitabine** and **cisplatin**. The regimen aims to provide synergistic effects by combining anti-angiogenesis, immune checkpoint inhibition, and cytotoxic chemotherapy. A Phase II trial (NCT04300959) led by Zhejiang Cancer Hospital demonstrated that this four-drug combination significantly improved progression-free survival and objective response rates compared to gemcitabine and cisplatin alone as a first-line treatment for unresectable or metastatic biliary tract cancer.

Other names
Anlotinib + Sintilimab + GemCisAnlotinib + PD-1 + Gemcitabine + CisplatinAnlotinib Hydrochloride in Combination With PD1 With Gemcitabine Plus Cisplatin
02

Targets

DNAPDCD1 (Programmed cell death protein 1 receptor)PDGFRB (Platelet-derived growth factor receptor beta)RNR (Ribonucleotide reductase)VEGFR-1 (Vascular endothelial growth factor receptor 1)VEGFR2 (Vascular endothelial growth factor receptor 2)VEGFR4 (Vascular endothelial growth factor Receptor-3)KIT (c-KIT proto-oncogene receptor tyrosine kinase)FGFR1 (Fibroblast growth factor receptor 1)FGFR2 (Keratinocyte growth factor receptor)FGFR3 (Fibroblast growth factor receptor 3)FGFR4 (Fibroblast growth factor receptor 4)PDGFRA (Platelet-derived growth factor receptor alpha)

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