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Study details
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A Phase Ⅲ Clinical Trial of HLX22

Shanghai Henlius Biotech
NCT IDNCT06532006ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

550

Study length

about 3.8 years

Ages

18+

Locations

29 sites in CA, CO, FL +11

What this study is about

Researchers are testing a treatment called HLX22 when used with trastuzumab and chemotherapy as the first treatment for HER2-positive gastric or gastroesophageal junction cancer. The trial will last about 1379 days, and it involves comparing this new treatment to standard care.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Capecitabine
  • 2.Take HLX22
  • 3.Take Oxaliplatin
  • +2 more

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
OralInjection / IV

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

capecitabine, oxaliplatin, pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer), trastuzumab (Monoclonal antibody; targets HER2 protein on cancer cells)

Drug routes

oral (Oral Tablet), injection (Injection), infusion, injection, intravenous

Endpoints

Primary: Overall Survival (OS), Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)

Secondary: Adverse events (AE), Objective Response Rate (ORR) assessed by IRRC and investigator per RECIST v1.1, PFS per RECIST 1.1 assessed by investigator