Home › Trials › NCT06532006

Treatment for HER2-positive gastric and gastroesophageal junction cancer

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

Phase 3 Interventional Shanghai Henlius Biotech · NCT06532006

This study is testing a new treatment combining HLX22, trastuzumab, and chemotherapy to see if it helps people with advanced HER2-positive stomach cancer feel better compared to standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment550 (estimated)
Ages18 Years and up
SexAll
SponsorShanghai Henlius Biotech Industry-sponsored
Drugs / interventionschemotherapy, trastuzumab, pembrolizumab
Locations208 sites (Anaheim, California and 207 other locations)
Trial IDNCT06532006 on ClinicalTrials.gov

What this trial studies

This phase Ⅲ clinical study evaluates the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for patients with HER2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma. Participants will be randomly assigned to receive either the experimental treatment or a placebo alongside standard chemotherapy. The treatment will continue until there is a loss of clinical benefit, intolerable toxicity, or other specified reasons. The study aims to determine if the combination therapy can improve patient outcomes compared to the control group.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with untreated, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Not a fit: Patients with other malignant tumors within the last two years or those who have shown disease progression after prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with HER2-positive gastric cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of monoclonal antibodies and chemotherapy in treating HER2-positive cancers.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male/female who are at least 18 years of age on the day of signing the informed consent.
2. With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
3. Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
4. HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory on a primary or metastatic tumor.
5. ECOG PS within 7 days before randomization: 0-1.
6. Expected survival ≥ 6 months.
7. Had adequate organ function

Exclusion Criteria:

1. Patients with other malignant tumors within 2 years before the randomization.
2. Evidence of disease progression within 6 months (before randomization) after completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
3. Previous treatment with any HER2-target therapy.
4. Active gastrointestinal bleeding
5. Presence of central nervous system (CNS) metastases.
6. Left ventricular ejection fraction (LVEF) \< 55%.
7. Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.

Where this trial is running

Anaheim, California and 207 other locations

+158 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Gastroesophageal-junction CancerMonoclonal AntibodyGastric CancerHER2-positive Gastric Cancer
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.