This study intends to explore the predictive biomarkers by Next-generation sequencing (NGS) and multiple immunohistochemistry (mIHC) for the treatment of SHR-1210 in combination with paclitaxel and platinum in advanced esophageal cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
SHR-1210 (camrelizumab) + albumin-bound paclitaxel + Carboplatin
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGObjective Response Rate (ORR)
ORR is determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Time frame: up to approximately 1 year
Progression-Free Survival (PFS)
It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
Time frame: up to approximately 1 year
Overall Survival (OS)
Defined as the time from the enrollment to death from any cause
Time frame: up to approximately 1 year
Disease Control Rate (DCR)
The proportion of patients who have achieved complete response, partial response and Stable disease assessed by investigators according to Recist v 1.1.
Time frame: up to approximately 1 year
Adverse events (AEs)
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03
Time frame: up to approximately 1 year
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