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)
Overview
- Phase
- Phase 2
- Intervention
- Anlotinib plus Sintilimab
- Conditions
- Colorectal Cancer
- Sponsor
- Shanghai Changzheng Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Objecitve response rate
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Yuan-Sheng Zang
Director
Shanghai Changzheng Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Anlotinib and Sintilimab
the combination of Anlotinib with Sintilimab as first-line treatment
Intervention: Anlotinib plus Sintilimab
Outcomes
Primary Outcomes
Objecitve response rate
Time Frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
Secondary Outcomes
- Deepness of response(Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks)
- Incidence of Treatment-related adverse Events(Through study completion, an average of 3 weeks)
- Progress Free Survival(Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 6 weeks)
- Overall Survival(From date of treatment beginning until the date of death from any cause, through study completion, an average of 3 weeks)
- Disease control rate(Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks)