A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer

Summary

This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  HLX22

  HLX22 15mg/kg Q3w

• Drug
  Pembrolizumab

  Pembrolizumab 200mg q3w

• Drug
  Trastuzumab

  Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W

• Drug
  Oxaliplatin

  Oxaliplatin 130 mg/m2 ,Q3W

• Drug
  Capecitabine

  Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W

Locations (208)