胃食道接合部癌および胃癌に対するHLX22とトラスツズマブおよび化学療法の併用療法の第Ⅲ相臨床試験

基本情報

NCT ID

NCT06532006

ステータス

募集中

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

550

治験依頼者名

Shanghai Henlius Biotech

概要

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).

対象疾患

介入

依頼者（Sponsor）

実施施設 (5)