This is a randomized, double-blind multi-center, phase III study comparing the efficacy and safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma. After the interim analysis conducted by the iDMC, an open-label assignment of experimental arm therapy will continue in regions outside of China, in order to further evaluate the efficacy and safety of sintilimab in combination with chemotherapy in subjects representing the western population with advanced esophageal squamous cell carcinoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
746
For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
75mg/m\^2 IV Q3W day 1
87.5 mg/m\^2 IV Q3W day 1, day 8 for first cycle and 175mg/m\^2 IV Q3W day 1 after first cycle
800 mg/m\^2 IV continuous infusion over 24 hours daily on Days 1-5 Q3W
For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
St. Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center
Anaheim, California, United States
UC Irvine
Orange, California, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
IACT Health - John B. Amos Cancer center
Columbus, Georgia, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
OS in overall population
To compare the overall survival of sintilimab vs. placebo, in combination with chemotherapy, for first-line treatment in subjects with unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
Time frame: From date of randomization until the date of death from any cause, assessed up to 40 months.
OS in PD-L1 positive population
To compare the OS of sintilimab vs. placebo, in combination with chemotherapy, for first-line treatment in subjects with PD-L1 positive, unresectable, locally advanced, recurrent or metastatic ESCC
Time frame: From date of randomization until the date of death from any cause, assessed up to 40 months.
ORR in overall population
To compare the objective response rate between the two treatment arms in ITT population
Time frame: From date of randomization up to 28 months.
PFS in overall populationsubjects in ITT population
To compare the progression-free survival between the two treatment arms in ITT population
Time frame: From date of randomization up to 28 months
DCR in overall population
To compare the disease control rate between the two treatment arms in ITT population
Time frame: From date of randomization up to 28 months
DoR in overall population
To compare the duration of response between the two treatment arms in ITT population
Time frame: From date of randomization up to 28 months
ORR - PD-L1 positive
To compare the objective response rate between the two treatment arms in PD-L1 positive subjects in ITT population
Time frame: From date of randomization up to 28 months
DCR - PD-L1 positive
To compare the disease control rate between the two treatment arms in PD-L1 positive subjects in ITT population
Time frame: From date of randomization up to 28 months
DoR - PD-L1 positive
To compare the duration of response between the two treatment arms in PD-L1 positive subjects in ITT population
Time frame: From date of randomization up to 28 months
PFS - PD-L1 positive
To compare the progression-free survival between the two treatment arms in PD-L1 positive subjects in ITT population
Time frame: From date of randomization up to 28 months
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Texas Oncology, P.A.
Austin, Texas, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
Border Medical Oncology
East Albury, New South Wales, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Austin Hospital
Heidelberg, Victoria, Australia
...and 38 more locations