NCT06532006 · Shanghai Henlius Biotech
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
What this study is about
This is a where neither patients nor doctors know which treatment is given, randomly assigned, multiregion, comparative phase Ⅲ clinical study designed to evaluate the effectiveness 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 randomly assigned to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical
View original scientific description
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.
Interventions
DRUG
HLX22
HLX22 15mg/kg Q3w
DRUG
Pembrolizumab
Pembrolizumab 200mg q3w
DRUG
Trastuzumab
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
DRUG
Oxaliplatin
Oxaliplatin 130 mg/m2 ,Q3W
DRUG
Capecitabine
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W
Primary outcome measures
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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 gastri
Where
- Anaheim, California
- Los Alamitos, California
- Greeley, Colorado
- Deerfield Beach, Florida
- Fort Myers, Florida
- Plantation, Florida
- Pompano Beach, Florida
- St. Petersburg, Florida
- West Palm Beach, Florida
- Chicago, Illinois
- Des Moines, Iowa
- Iowa City, Iowa
And 15 more locations — see the full list below.
Collaborators
Henlius USA
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations