NCT05149807

Clinical Study of SHR-1701 Plus Chemotherapy as Perioperative Treatment in Subjects With Gastric Cancer

A Randomized, Double-Blind, Multi-Center Phase II/III Clinical Study of PD-L1 Antibody/TGF-βRII (SHR-1701) Plus Tegafur Gimeracil Oteracil Potassium and Oxaliplatin Versus Placebo Plus Tegafur Gimeracil Oteracil Potassium and Oxaliplatin as Perioperative Treatment in Subjects With Resectable Gastric Cancer or Gastroesophageal Junction Cancer

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Perioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Cancer

Interventions

Type	Name	Description
DRUG	SHR-1701 injection	SHR-1701 injection Tegafur Gimeracil Oteracil Potassium Oxaliplatin
DRUG	Placebo	Placebo Tegafur Gimeracil Oteracil Potassium Oxaliplatin

Timeline

• Start date: 2022-01-26
• Primary completion: 2024-04-03
• Completion: 2024-04-03
• First posted: 2021-12-08
• Last updated: 2025-08-20

Locations

20 sites across 1 country: China