A Phase 3 interventional study of HLX22 and Pembrolizumab in Gastroesophageal-junction Cancer, Monoclonal Antibody and Gastric Cancer, sponsored by Shanghai Henlius Biotech. Recruiting at 208 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Shanghai Henlius Biotech · Phase 3, Interventional, and Treatment
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).
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.
This study's planned enrollment of 550 is above the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Shanghai Henlius Biotech is the lead sponsor of 127 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), Q3W Subjects in the experimental group may use one of the treatments below: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) or HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) + placebo (for pembrolizumab)
Drug: HLX22 · Drug: Trastuzumab · Drug: Oxaliplatin · Drug: Capecitabine
Control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W Subjects in the control group may use one of the treatments below: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) or Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) + pembrolizumab
Drug: Pembrolizumab · Drug: Trastuzumab · Drug: Oxaliplatin · Drug: Capecitabine
HLX22 15mg/kg Q3w
Pembrolizumab 200mg q3w
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
Oxaliplatin 130 mg/m2 ,Q3W
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W
Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)
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
Time frame: Up to 5 years
Overall Survival （OS）
OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.
Time frame: Up to 5 years
PFS per RECIST 1.1 assessed by investigator
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
Time frame: Up to 5 years
Objective Response Rate (ORR) assessed by IRRC and investigator per RECIST v1.1
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.
Time frame: Up to 5 years
Adverse events (AE)
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.
Time frame: Up to 5 years
Showing the first 100 of 208 sites across 17 countries.
Plan to share: No
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Shanghai Henlius Biotech