This is a multi-center phase II/III clinical study consisting of two stages: Stage I is a single-arm open-label phase II study to preliminarily explore the efficacy and safety of SHR-1701 plus S-1 and oxaliplatin mainly by the endpoint of pCR rate. Stage II is a randomized, double-blind, multi-center phase III study of SHR-1701 plus S-1 and oxaliplatin versus placebo plus S-1 and oxaliplatin as perioperative treatment in subjects with resectable GC or GEJC. A total of 846 treatment naïve subjects will be enrolled, and primary endpoint of this stage is Independent Review Committee (IRC)-assessed EFS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
SHR-1701 injection Tegafur Gimeracil Oteracil Potassium Oxaliplatin
Placebo Tegafur Gimeracil Oteracil Potassium Oxaliplatin
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The Second Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Southern Medical University NanFang Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Xingtai People's Hospital
Xingtai, Hebei, China
Anyang Cancer Hospital
Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
...and 10 more locations
Phase II : Pathological Complete Response pCR rate.
pCR rate is defined as the proportion of subjects whose specimens (including primary lesion and lymph nodes) obtained during GC or GEJC radical surgery are pathologically assessed to be free of residual live tumor cells after neoadjuvant therapy.
Time frame: Up to approximately 23 months
Phase III : Event-free Survival (EFS)
EFS is defined as time from randomization to PD or death (whichever occurs first), detailed that tumor progression/recurrence or new lesion confirmed by RECIST v1.1 criteria or death due to any cause.
Time frame: Up to approximately 57 months
Disease-free Survival (DFS).
DFS is defined as time from R0 resection to PD or death (whichever occurs first), detailed that tumor recurrence or new lesion confirmed by RECIST v1.1 criteria or death due to any cause.
Time frame: Up to approximately 57 months
Preoperative Objective Response Rate (ORR).
Preoperative ORR is defined as proportion of enrolled or randomized subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) according to RECIST v1.1 criteria during neoadjuvant therapy period.
Time frame: Up to approximately 57 months
Major pathological response (MPR) rates.
MPR rate is defined as proportion of subjects whose primary lesion specimens obtained during GC or GEJC radical surgery are pathologically assessed to have \< 10% residual live tumor cells relative to the primary tumor tissue (Becker grade 1a or 1b) after neoadjuvant therapy.
Time frame: Up to approximately 23 months
R0 resection rate
R0 resection rate is defined as proportion of subjects without gross or microscopic residual tumor (negative margin) after neoadjuvant therapy and GC or GEJC radical surgery.
Time frame: Up to approximately 23 months
Overall Survival (OS).
OS is defined as time from randomization to death of any cause.
Time frame: Up to approximately 57 months
Percentage of Participants Who Experience One or More Adverse Events (AEs).
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience at least one AE will be presented.
Time frame: Up to approximately 57 months
30-day postoperative mortality.
30-day postoperative mortality is defined as proportion of subjects who died due to any reason within 30 days after radical surgery for GC.
Time frame: Up to approximately 24 months
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