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A Randomized, Double-Blind, Multi-Center, Phase III Clinical Study of SHR-1701 Plus Chemotherapy Versus Placebo Plus Chemotherapy as Treatment in Patients With Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

Trial Profile

A Randomized, Double-Blind, Multi-Center, Phase III Clinical Study of SHR-1701 Plus Chemotherapy Versus Placebo Plus Chemotherapy as Treatment in Patients With Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Jan 2026

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At a glance

  • Drugs Capecitabine (Primary) ; Oxaliplatin (Primary) ; Retlirafusp alfa (Primary)
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Suzhou Suncadia Biopharmaceuticals

Most Recent Events

  • 07 Jan 2026 According to a Jiangsu Hengrui Medicine media release, NMPA has approved Retlirafusp alfa Injection for marketing, for the first-line treatment of locally advanced unresectable, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma [PD-L1 positive (CPS >/= 1) by a fully validated test.] in combination with fluorouracil and platinum-based drugs.
  • 30 Mar 2025 Planned End Date changed from 30 Jun 2025 to 1 Oct 2025.
  • 19 Sep 2024 According to a Jiangsu Hengrui Medicine media release, Suzhou Shengdiya Biomedical Co (a subsidiary of Jiangsu Hengrui Pharmaceuticals Co Ltd), has received an ''Acceptance Notice'' from the National Medical Products Administration (NMPA), indicating that the marketing authorization application for its Relafup-alpha injection (SHR-1701) has been accepted by the NMPA.

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