To evaluate the efficacy, safety and pharmacokinetic characteristics of HR070803 in the treatment of advanced esophageal cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
HR070803
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGObjective response rate
The study is designed to evaluate the objective response rate of HR070803 in patients with advanced esophageal cancer. ORR is defined as percentage of patients achieving a best response of complete response (CR) or partial response (PR) as per RECIST version 1.1.
Time frame: for 4 months following the date the last patient was randomized
Progression Free Survival
The study is designed to evaluate the progression free survival of HR070803 in patients with advanced esophageal cancer. PFS is defined as the time from first medication to disease progression or death, whichever is earlier
Time frame: for 4 months following the date the last patient was randomized
Disease Control Rate
The study is designed to evaluate the disease control rate of HR070803 in patients with advanced esophageal cancer. DCR is defined as the percentage of patients with a best response of CR, PR, or stable disease (SD)
Time frame: for 4 months following the date the last patient was randomized
Duration of Response
The study is designed to evaluate the duration of response of HR070803 in patients with advanced esophageal cancer. DoR is defined as the time from first documentation of response (CR or PR whichever occurred first, as per RECIST version 1.1) to disease progression or death, whichever is earlier.
Time frame: for 4 months following the date the last patient was randomized
Overall Survival
The study is designed to evaluate the overall survival of HR070803 in patients with advanced esophageal cancer. OS is defined as the time from first medication to death of any cause, censored for patients alive at data cut-off.
Time frame: for 6 months following the date the last patient was randomized
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Number of Patients with Adverse Events as Assessed by NCI-CTCAE V5.0
Safety and tolerability will consist of monitoring and recording all AEs and SAEs as characterized by type, incidence, severity, and the relationship to the study therapy. AEs will be evaluated for all treated patients using NCI-CTCAE V5.0.
Time frame: for 6 months following the date the last patient was randomized
ECOG Score for performance status
Time frame: for 6 months following the date the last patient was randomized