HLX22 with Trastuzumab and Chemotherapy for Gastric Cancer

This study is testing a new treatment combination for HER2-positive gastric (stomach) or gastroesophageal junction (where the esophagus meets the stomach) cancer that has spread or cannot be removed by surgery. You might be eligible if you have this type of cancer and haven't received prior treatment for it. The study is comparing HLX22, a monoclonal antibody (a type of targeted therapy), given with trastuzumab and chemotherapy (oxaliplatin and capecitabine), against a placebo (an inactive substance) combined with trastuzumab and chemotherapy. Researchers want to see if adding HLX22 helps patients live longer without their cancer getting worse (Progression-Free Survival) and how long they live overall (Overall Survival), with results measured for up to 5 years. The study is currently recruiting participants.

Study design
This is a double-blind, randomized study, meaning neither you nor your doctors will know if you are receiving HLX22 or the placebo. About 550 participants will be randomly assigned to one of two treatment groups.
What's involved
You would receive the study drug combination every three weeks until your cancer worsens, you experience severe side effects, or you choose to stop participating.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow your progress for up to 5 years to assess how long you live without your cancer worsening and your overall survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06532006

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Shanghai Henlius Biotech
~550 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:HLX22PembrolizumabTrastuzumabOxaliplatinCapecitabine

At a glance

Recruiting sites
206 of 208 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)
Measured over Up to 5 years
+1 more outcome measured
Gastroesophageal-junction Cancer
Monoclonal Antibody
Gastric Cancer
HER2-positive Gastric Cancer
208 sites across 49 states
China48
Japan23
Turkey (Türkiye)11
Poland10
South Korea10
Spain9
Germany7
Italy7

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  • 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.