This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
In this study, eligible subjects will be randomized into study arm or control arm. Treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and overall survival (OS) will be the primary outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
596
Cancer Center of Sun-Yat Sen University (CCSYSU)
Guangzhou, Guangdong, China
PFS assessed by IRC
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time frame: approximately 22 months
OS
OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier.
Time frame: approximately 22 months
PFS assessed by investigators
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time frame: approximately 22 months
6 and 9 month OS rate
OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier.
Time frame: approximately 6 and 9 months
ORR
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time frame: approximately 22 months
DCR
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time frame: approximately 22 months
DoR
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time frame: approximately 22 months
AE
adverse events
Time frame: approximately 22 months
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cisplatin 75mg/m2