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RecruitingLast updated: 14 May 2026

HLX22-GC-301: A study evaluating targeted antibody treatment called HLX22 when given with other drugs to treat stomach and gastroesophageal junction cancer that is HER2+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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Trial acronym

HLX22-GC-301

Clinical summary

Summary

This study is evaluating how safe and effective a medicine called HLX22 is when given in combination with trastuzumab, chemotherapy and immunotherapy as a first-line treatment.

You may be eligible for this study if you have HER2+ locally advanced or metastatic cancer of the stomach or gastro-oesophageal junction. You should not have had prior treatment for your advanced disease. Prior treatment for an earlier stage of disease is permitted.

Eligible participants will be randomly allocated (by chance) to one of two treatment groups:

  • Experimental group: HLX22 + trastuzumab + chemotherapy, with or without a placebo for immunotherapy.
  • Control group: Placebo for HLX22 + trastuzumab + chemotherapy, with or without immunotherapy.

 

Conditions

This trial is treating people with Locally advanced or metastatic gastroesophageal junction and gastric cancer

Eligibility

Inclusion

  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

  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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Shanghai Henlius Biotech

Scientific Title

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

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