NCT04271813

Anlotinib Plus Sintilimab as First-line Treatment for Patients With Advanced Colorectal Cancer (APICAL-CRC)

Anlotinib Plus Sintilimab as First-line Treatment for Patients With Advanced Colorectal Cancer (APICAL-CRC): a Single Center, Single-arm Phase II Study (APICAL-CRC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and safety of the combination of Anlotinib and Sintilimab in advanced colorectal cancer as first-line treatment.

Detailed description

Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. Sintilimab is a fully human IgG4 monoclonal antibody that binds to programmed cell death receptor-1 (PD-1), thereby blocking the interaction of PD-1 with its ligands (PD-L1 and PL-L2) and consequently helping to restore the endogenous antitumour T-cell response. In the present study, we design a single-arm, single center Phase II trial to evaluate the efficacy and safety of the combination of Anlotinib and Sintilimab in advanced colorectal cancer as first-line treatment.

Conditions

• Colorectal Cancer
• Immunotherapy
• Anlotinib
• Sintilimab
• Chemo-free Therapy
• First-line Treatment

Interventions

Type	Name	Description
DRUG	Anlotinib plus Sintilimab	Anlotinib 12mg oral administration daily d1-d14, q3w; Sintilimab 200mg iv drop d1, q3w

Timeline

• Start date: 2020-06-01
• Primary completion: 2023-09-30
• Completion: 2024-02-29
• First posted: 2020-02-17
• Last updated: 2024-04-23

Locations

1 site across 1 country: China