No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
550 (estimated)
Sponsor
Shanghai Henlius Biotech · Industry
Who this trial is looking for
This trial is looking for adults with a type of stomach cancer called HER2-positive gastric cancer. Participants will receive a combination of treatments including HLX22, trastuzumab, and chemotherapy, and will be monitored for how well it works and if there are side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with HER2-positive gastric or gastroesophageal junction adenocarcinoma.
I have measurable cancer that is not only in my bones.
I have an ECOG performance status of 0 or 1.
I expect to live at least 6 more months.
I have adequate organ function.
You may not be able to join if
I have had other cancers in the last 2 years.
I had disease progression within 6 months after previous cancer treatments.
I have received treatment targeting HER2 before.
I am currently experiencing gastrointestinal bleeding.
I have central nervous system metastases.
My heart's left ventricle does not pump enough blood (LVEF < 55%).
I have a history of severe allergy to monoclonal antibodies or components of this treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 base…
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).
Trial Locations
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City
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Status
Eligibility 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 adenoca…
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.
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