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

Condition(s) studied

Investigational drug(s) / intervention(s)

HLX22: HLX22 15mg/kg Q3w

Pembrolizumab: Pembrolizumab 200mg q3w

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

Oxaliplatin: Oxaliplatin 130 mg/m2 ,Q3W

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

Study 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).

Eligibility

Primary outcome measure(s)

• Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee) — Up to 5 years
  PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm
• Overall Survival （OS） — Up to 5 years
  OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.

Trial sites (208)

+ 168 more sites — see the full list on the official registry below.