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

NCT06532006 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2026-02-27

No results posted yet for this 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).

Conditions

  • Gastroesophageal-junction Cancer
  • Monoclonal Antibody
  • Gastric Cancer
  • HER2-positive Gastric Cancer

Interventions

DRUG

HLX22

HLX22 15mg/kg Q3w

DRUG

Pembrolizumab

Pembrolizumab 200mg q3w

DRUG

Trastuzumab

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

DRUG

Oxaliplatin

Oxaliplatin 130 mg/m2 ,Q3W

DRUG

Capecitabine

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-22
Primary Completion
2027-06-01
Completion
2028-09-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Chile
  • China
  • Georgia
  • Germany
  • Greece
  • Italy
  • Japan
  • Peru
  • Poland
  • Romania
  • South Korea
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06532006 on ClinicalTrials.gov