Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer

  • End date
    Sep 13, 2024
  • participants needed
  • sponsor
    Shanghai Henlius Biotech
Updated on 13 May 2022
measurable disease
gastric adenocarcinoma
cancer chemotherapy
metastatic gastric cancer
xelox regimen


The purpose of this study is to evaluate the clinical efficacy and safety of HLX22 in the HER2+ Locally Adanved or Metastatic Gastric Cancer as the first-line therapy.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. The enrolled subjects will receive an intravenous infusion of HLX22/placebo and SOC(standard of care: Trastuzumab + XELOX) once every 3 weeks until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent or other reasons as specified in the protocol(whichever occurs earlier).


HLX22(25mg/kg) or HLX22(15mg/kg) or placebo will be administered intravenously [IV] on day 1 of each 3-week cycle. Trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance dose) will be administered IV on day 1 of each 3-week cycle. SOC chemotherapy is XELOX (1000 mg/m^2 capecitabine administered orally twice daily [BID] on days 1-14 of each 3-week cycle and 130 mg/m^2 oxaliplatin administered IV on Day 1 of each 3-week cycle).

Condition Gastric Cancer
Treatment Capecitabine, Placebo, Trastuzumab, Oxaliplatin, HLX22
Clinical Study IdentifierNCT04908813
SponsorShanghai Henlius Biotech
Last Modified on13 May 2022


Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2 positive gastric adenocarcinoma
HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor
Has measurable disease as defined by RECIST 1.1 as determined by the IRRC
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Has a life expectancy of greater than 6 months
Has adequate organ function

Exclusion Criteria

Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
Has history of HER2 targeted therapy
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 7 months after the last dose of trial treatment
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