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NCT Number: NCT06532006

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

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).

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Key information

Conditions

Gastroesophageal-junction Cancer Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms HER2-positive Gastric Cancer Monoclonal Antibody Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Investigacion Pergamino SA, Buenos Aires, Argentina

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About this study

In experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), once every 3 weeks (Q3W).

In control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with other malignant tumors within 2 years before the randomization.
  • 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.
  • Previous treatment with any HER2-target therapy.
  • Active gastrointestinal bleeding
  • Presence of central nervous system (CNS) metastases.
  • Left ventricular ejection fraction (LVEF) < 55%.
  • Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.

Treatment and study plan

HLX22

Drug

HLX22 15mg/kg Q3w

Pembrolizumab

Drug

Pembrolizumab 200mg q3w

Trastuzumab

Drug

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

Oxaliplatin

Drug

Oxaliplatin 130 mg/m2 ,Q3W

Capecitabine

Drug

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

Primary outcomes

  1. Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)

    Time frame: Up to 5 years

    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm

  2. Overall Survival （OS）

    Time frame: Up to 5 years

    OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.

Secondary outcomes

  1. PFS per RECIST 1.1 assessed by investigator

    Time frame: Up to 5 years

    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm

  2. Objective Response Rate (ORR) assessed by IRRC and investigator per RECIST v1.1

    Time frame: Up to 5 years

    ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1. ORR will be determined for each treatment arm.

  3. Adverse events (AE)

    Time frame: Up to 5 years

    An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for each treatment arm.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Li

CONTACT

[email protected]

+86 18810366427

Sponsors and collaborators

Lead sponsor

Shanghai Henlius Biotech

Industry

Collaborators

  • Henlius USA

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 1, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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