Clinical Study of SHR-1701 Plus Chemotherapy as Perioperative Treatment in Subjects With Gastric Cancer
Status:
Not yet recruiting
Trial end date:
2027-12-31
Target enrollment:
Participant gender:
Summary
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.