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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
550
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
Los Angeles Cancer Network
Anaheim, California, United States
RECRUITINGOPN - Oncology Physician Network (Los Alamitos)
Los Alamitos, California, United States
RECRUITINGBanner MD Anderson Cancer Center
Greeley, Colorado, United States
RECRUITINGAdvanced Research LLC
Deerfield Beach, Florida, United States
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
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Florida Cancer Specialist - South
Fort Myers, Florida, United States
RECRUITINGBRCR Medical Center
Plantation, Florida, United States
RECRUITINGNapa Research
Pompano Beach, Florida, United States
RECRUITINGFlorida Cancer Specialist - North
St. Petersburg, Florida, United States
RECRUITINGFlorida Cancer Specialist - East
West Palm Beach, Florida, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITING...and 78 more locations