Treatment for HER2-positive gastric and gastroesophageal junction cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Los Angeles Cancer Network
  Anaheim, California, United States Recruiting
• OPN - Oncology Physician Network (Los Alamitos)
  Los Alamitos, California, United States Recruiting
• Banner MD Anderson Cancer Center
  Greeley, Colorado, United States Recruiting
• Advanced Research LLC
  Deerfield Beach, Florida, United States Recruiting
• Florida Cancer Specialist - South
  Fort Myers, Florida, United States Recruiting
• BRCR Medical Center
  Plantation, Florida, United States Recruiting

+158 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Ying Li
• Email: ying_li1@henlius.com
• Phone: +86 18810366427

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combination treatment for advanced HER2-positive gastric cancer

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  Recruiting at 219 sites Phase 3 Daiichi Sankyo · New Haven, Connecticut and 249 other locations · NCT06731478

• New treatment for HER2-positive gastric cancer using rilvegostomig and chemotherapy

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• Treatment for HER2-positive gastric cancer after surgery

  This study is testing if a new combination treatment can help people with HER2-positive gastric cancer feel better after their surgery if they still have some cancer left.

  Recruiting Phase 2 Gruppo Oncologico del Nord-Ovest · Milan · NCT06253650

• CA-4948 combined with chemotherapy and immunotherapy for advanced gastric and esophageal cancer

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  Recruiting Phase 1 Washington University School of Medicine · St Louis, Missouri · NCT05187182

• Neoadjuvant trastuzumab, durvalumab, and FLOT for HER2-positive gastric or GEJ cancer

  This study tests a pre-surgery treatment combining trastuzumab, durvalumab, and FLOT for patients with HER2-positive locally advanced gastric or gastroesophageal junction cancer to see how many achieve complete tumor disappearance.

  Recruiting Phase 2 Samsung Medical Center · Seoul, Gang-Nam · NCT07911280

• Adding 2141-V11 to standard therapy for advanced esophageal, gastric, or gastroesophageal junction cancer

  This study tests whether adding the drug 2141-V11 to standard anti-PD-1 therapy (with or without 5-FU) is safe for adults with advanced or metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.