OncoMatch/Clinical Trials/NCT06532006
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
Is NCT06532006 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for gastroesophageal-junction cancer.
Treatment: HLX22 · Pembrolizumab · Trastuzumab · Oxaliplatin · Capecitabine — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+)
HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory
Required: HER2 (ERBB2) overexpression (IHC 2+ in combination with ISH+ or FISH)
HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: HER2-targeted therapy
Previous treatment with any HER2-target therapy
Lab requirements
Blood counts
adequate organ function
Kidney function
adequate organ function
Liver function
adequate organ function
Cardiac function
Left ventricular ejection fraction (LVEF) >= 55%
Had adequate organ function; Left ventricular ejection fraction (LVEF) < 55% [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Los Angeles Cancer Network · Anaheim, California
- OPN - Oncology Physician Network (Los Alamitos) · Los Alamitos, California
- Banner MD Anderson Cancer Center · Greeley, Colorado
- Advanced Research LLC · Deerfield Beach, Florida
- Florida Cancer Specialist - South · Fort Myers, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06532006 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify