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A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
Sponsor: Shanghai Henlius Biotech
Summary
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).
Official title: A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
550
Start Date
2024-11-22
Completion Date
2028-09-01
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
HLX22
HLX22 15mg/kg Q3w
Pembrolizumab
Pembrolizumab 200mg q3w
Trastuzumab
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
Oxaliplatin
Oxaliplatin 130 mg/m2 ,Q3W
Capecitabine
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W
Locations (208)
Los Angeles Cancer Network
Anaheim, California, United States
OPN - Oncology Physician Network (Los Alamitos)
Los Alamitos, California, United States
Banner MD Anderson Cancer Center
Greeley, Colorado, United States
Advanced Research LLC
Deerfield Beach, Florida, United States
Florida Cancer Specialist - South
Fort Myers, Florida, United States
BRCR Medical Center
Plantation, Florida, United States
Napa Research
Pompano Beach, Florida, United States
Florida Cancer Specialist - North
St. Petersburg, Florida, United States
Florida Cancer Specialist - East
West Palm Beach, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Mission Cancer + Blood (Exigent Network)
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center - University of Iowa
Iowa City, Iowa, United States
Washington University School of Medicine St. Louis
St Louis, Missouri, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Comprehensive Cancer Centers Nevada
Las Vegas, Nevada, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Guthrie Medical Group, PC and Robert Packer Hospital (Guthrie Cancer Center - Sayre)
Sayre, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
HCA Midwest Health
Nashville, Tennessee, United States
Texas Oncology - West (SCRI)
Abilene, Texas, United States
Texas Oncology Central South (SCRI)
Austin, Texas, United States
Texas Oncology Northeast (SCRI)
Denton, Texas, United States
The University of Texas MD Anderson cancer Center
Houston, Texas, United States
Texas Oncology - Gulf Coast (SCRI)
Webster, Texas, United States
American Oncology Network Vista Oncology Division
Olympia, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, United States
Centro de Investigacion Pergamino SA
Buenos Aires, Buenos Aires, Argentina
União Brasileira de Educação e Assistência
Puerto Alegre, RS, Argentina
Centro de Investigaciones Clinicas. Clinica Viedma S.A.
Viedma, Río Negro Province, Argentina
Instituto de Oncologia de Rosario
Cordoba, Santa Fe Province, Argentina
Centro Médico Privado CEMAIC
Cordoba, Santa Fe Province, Argentina
Sanatorio Plaza - Fundacion Pita
Rosario, Santa Fe Province, Argentina
Sanatorio de la Mujer
Rosario, Santa Fe Province, Argentina
Beneficência Portuguesa de São Paulo
San Pablo, SP, Argentina
Fundacion CENIT
Buenos Aires, Argentina
IONC Instituto Oncologico de Cordoba
Córdoba, Argentina
Instituto San Marcos
San Juan, Argentina
CER - Centro de Rehabilitacion Medica San Juan
San Juan, Argentina
Exelsus
San Miguel de Tucumán, Argentina
St. Vincent Hospital Melbourne
Fitzroy, Melbourne, Australia
Peninsula Health-Frankston hospital
Frankston, Melbourne, Australia
University of the Sunshine Coast Clinical Trials, Sunshine Coast Haematology and Oncology Clinic
Sunshine Coast, Queensland, Australia
GenesisCare Research
Campbelltown, Sydney, Australia
Central Coast Local Health District (Gosford and Wyong Hospital)
Gosford, Sydney, Australia
Macquarie University
North Ryde, Sydney, Australia
Concord Repatriation General Hospital
Concord, Australia
Personal Oncologia de Precisio e Personalizada
Belo Horizonte, Minas Gerais, Brazil
Instituto de Oncologia do Paraná - IOP Pequisa
Curitiba, Paraná (PR), Brazil
Real Hospital de Beneficencia Portuguesa
Recife, Pernambuco, Brazil
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, Brazil
Centro Gaúcho Integrado - Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Hematologia e Oncologia Viver
Santa Maria, Rio Grande Do Sul (RS), Brazil
ANIMI - Unidade de Tratamento Oncologico
Lages, Santa Catarina, Brazil
Brazilian Institute for Cancer Control (IBCC)
Vila Mariana, São Paulo, Brazil
Hospital Santa Marcelina HSM
São Paulo, Brazil
Centro de Oncologia de Precision
Santiago, Santiago Metropolitan, Chile
Instituto del Cancer RedSalud Vitacura
Santiago, Santiago Metropolitan, Chile
Icegclinic
Santiago, Chile
Fundacion Arturo Lopez Perez
Santiago, Chile
Affiliated Hospital of Youjiang Medical University for Nationalities
Baise City, China
Beijing Cancer Hospital
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Peking Union Medical College Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical University
Bengbu, China
The First Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, China
The First People's Hospital of Changzhou
Changzhou, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, China
West China Hospital of Sichuan University
Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Dezhou Second People's hospital
Dezhou, China
Fujian Cancer Hospital
Fuzhou, China
Zhongshan City People's Hospital
Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
Hangzhou, China
The First Affiliated Hospital, Zhejiang University School of Medic
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
The Second Hospital of Anhui Medical University
Hefei, China
Cancer Hospital of Shandong First Medical University
Jinan, China
Gansu Provincial Cancer Hospital
Lanzhou, China
Gansu Provincial Hospital
Lanzhou, China
Gansu Wuwei Tumour Hospital
Lanzhou, China
The First Hospital Of Lanzhou University
Lanzhou, China
Liuzhou Workers' Hospital
Liuchow, China
The First Affiliated Hospital of Henan University of Science
Luoyang, China
Mianyang Central Hospital
Mianyang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Province Hospital
Nanjing, China
Nanjing Drum Tower Hospital
Nanjing, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Fudan University Shanghai Cancer Center
Shanghai, China
Renji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, China
The Central Hospital of Shaoyang
Shaoyang, China
Liaoning Medical University Cancer Institute & Hospital
Shenyang, China
The Fourth Hospital of Hebei Medical University
Shijia Zhuang, China