This study was designed to explore the clinical efficacy of SHR-1210 in combined with Anlotinib in the treatment of second- or above- line advanced or metastatic esophageal squamous cell cancer patients, in order to find a better therapy strategy for esophageal squamous cell cancer patients.
This is a prospective, phase II, single-arm clinical trial. Advanced or metastatic esophageal squamous cell cancer(ESCC) patients progressed after 1st systematic treatment are treated with SHR-1210 and Anlotinib. SHR-1210 was given intravenously(200mg d1 Q2w), combined with Anlotinib orally, 12 mg d1-14 Q3w. The hypothesis: The objective response rate in SHR-1210 combined with Anlotinib can reach 40% as second-line or above treatment of advanced or metastatic ESCC patients. The primary endpoint is objective response rate (ORR) and the secondary endpoint is disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and safety of this regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
SHR-1210: a novel anti-PD-1 antibody Anlotinib: a multi-kinase inhibitor
ORR based on RECIST v1.1
Objective response rate based on RECIST v1.1 by investigators
Time frame: 12 months
DCR based on RECIST v1.1
Disease control rate based on RECIST v1.1 by investigators
Time frame: 12 months
Overall survival
Overall survival based on RECIST v1.1 by investigators
Time frame: 24 months
Progression free survival
Progression free survival based on RECIST v1.1 by investigators
Time frame: 12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety and tolerance by investigators
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.