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

Phase 2

Completed

• Conditions: Anlotinib; Immunotherapy; Colorectal Cancer; Sintilimab; Chemo-free Therapy; First-line Treatment
• Interventions: Drug: Anlotinib plus Sintilimab

• Registration Number: NCT04271813
• Lead Sponsor: Shanghai Changzheng Hospital

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.

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-17
• Study Start: 2020-06-01
• Primary Completion: 2023-09-30
• Study Completion: 2024-02-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anlotinib and Sintilimab	Anlotinib plus Sintilimab	the combination of Anlotinib with Sintilimab as first-line treatment

Primary Outcome Measures

Name	Time	Method
Objecitve response rate	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 Outcome Measures

Name	Time	Method
Deepness of response	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks	Investigation of depth of response during first-line treatment
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	Time from treatment beginning until disease progression
Overall Survival	From date of treatment beginning until the date of death from any cause, through study completion, an average of 3 weeks	Time from treatment beginning until death from any cause
Disease control rate	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks	Proportion of patients who achieved a complete response, a partial response, or stable diseas

Trial Locations

Locations (1)

Department of Medical Oncology, Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China