Overview

A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

Status:
RECRUITING

Trial end date:
2028-09-01

Target enrollment:

Participant gender:

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).

Phase:

PHASE3

Details

Lead Sponsor:

Shanghai Henlius Biotech

Collaborator:

Henlius USA

Treatments:

Capecitabine
Oxaliplatin
pembrolizumab
Trastuzumab