A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy (XELOX) versus Trastuzumab and Chemotherapy (XELOX) with or without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516633-12-00

Acronym

HLX22-GC-301

Enrollment

106

Registered

2025-04-22

Start date

2025-06-30

Completion date

Unknown

Last updated

2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced/ metastatic gastroesophageal junction and gastric cancer

Brief summary

Progression-free survival (PFS) (assessed by the Blinded Independent Central Review [BICR] per RECIST v1.1)., Overall survival (OS).

Detailed description

Progression-free survival (PFS) (assessed by investigator per RECIST v1.1)., Objective response rate (ORR) (assessed by BICR and investigator per RECIST v1.1)., Progression-free survival on next line of therapy (PFS2) (assessed by investigator per RECIST v1.1), Duration of response (DOR) (assessed by BICR and investigator per RECIST v1.1)., Incidence of adverse events (AEs) and serious adverse events (SAEs)., Pharmacokinetics (PK): concentration of HLX22 in serum., Immunogenicity evaluation: incidence of anti-drug antibody (ADA) and neutralizing antibody (NAb) of HLX22., Quality of life assessment.

Interventions

DRUGPEMBROLIZUMAB

DRUGplacebo_HLX22

DRUGplacebo_pembrolizumab

DRUGRecombinant Humanized Anti-HER2 Monoclonal Antibody Injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) (assessed by the Blinded Independent Central Review [BICR] per RECIST v1.1)., Overall survival (OS).	—

Secondary

Measure	Time frame
Progression-free survival (PFS) (assessed by investigator per RECIST v1.1)., Objective response rate (ORR) (assessed by BICR and investigator per RECIST v1.1)., Progression-free survival on next line of therapy (PFS2) (assessed by investigator per RECIST v1.1), Duration of response (DOR) (assessed by BICR and investigator per RECIST v1.1)., Incidence of adverse events (AEs) and serious adverse events (SAEs)., Pharmacokinetics (PK): concentration of HLX22 in serum., Immunogenicity evaluation: incidence of anti-drug antibody (ADA) and neutralizing antibody (NAb) of HLX22., Quality of life assessment.	—

Measure

Time frame

—

Countries

Germany, Greece, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026