Clinical trials
Follow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
HAIC + donafenib + sintilimab
- Development stage
- Phase 2
- Lead developer
- Zhongda Hospital, Southeast University
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
- Administration
- Oral, Intravenous, Intra-arterial
01
Overview
HAIC + donafenib + sintilimab is a combination therapy regimen being evaluated for the first-line treatment of unresectable intrahepatic cholangiocarcinoma (ICC). The regimen integrates three distinct therapeutic modalities: Hepatic Arterial Infusion Chemotherapy (HAIC) using the GEMOX regimen (gemcitabine and oxaliplatin), which provides high local concentrations of cytotoxic agents directly to the liver; donafenib, an oral multi-kinase inhibitor that targets VEGFR, PDGFR, and the Raf/MEK/ERK pathway to inhibit angiogenesis and tumor proliferation; and sintilimab, a recombinant humanized IgG4 monoclonal antibody that targets the programmed cell death protein 1 (PD-1) to enhance anti-tumor immune responses. This synergistic approach, studied in the CHANCE 2203 trial led by Zhongda Hospital, aims to improve local control and systemic efficacy in patients with advanced biliary tract malignancies by leveraging the immunogenic cell death induced by locoregional chemotherapy alongside targeted and immune checkpoint inhibition.
- Brand names
- Zeponid
- Other names
- HAIC plus donafenib and sintilimabGEMOX-HAIC + donafenib + sintilimabHepatic Arterial Infusion Chemotherapy + donafenib + sintilimab
02
Targets
BRAF V600EDNADNA polymerase familyFLT3 (Fms related receptor tyrosine kinase 3)PDCD1 (Programmed cell death protein 1 receptor)PDGFRB (Platelet-derived growth factor receptor beta)RAF1 (c-Raf-1 (Y340D/Y341D))RET (Rearranged during transfection receptor tyrosine kinase)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)RNR (Ribonucleotide reductase)
Beyond the preview
Go deeper on HAIC + donafenib + sintilimab.
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Indications & development
Explore development by indication, patient population, and geography.
- Indications
- Development status
- Countries
Licensing & deals
Trace asset ownership, licensing agreements, and commercial partnerships.
- Partners
- Deal terms
- Milestones
Patents & exclusivity
Explore the patent landscape and regulatory exclusivity around an asset.
- Patents
- Expiration dates
- Exclusivity
Competitive landscape
Compare development programs by target, modality, and indication.
- Competing assets
- Targets
- Development stage
Research & analysis
Connect source evidence and development news to your research questions.
- Publications
- News
- Analysis
Bring the full picture into focus.
See how Gosset can support your research on HAIC + donafenib + sintilimab.