A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
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
1 other identifier
interventional
550
17 countries
208
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2024
Typical duration for phase_3
208 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
August 1, 2024
CompletedStudy Start
First participant enrolled
November 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
February 27, 2026
December 1, 2025
2.5 years
July 25, 2024
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
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.
Up to 5 years
Secondary Outcomes (3)
PFS per RECIST 1.1 assessed by investigator
Up to 5 years
Objective Response Rate (ORR) assessed by IRRC and investigator per RECIST v1.1
Up to 5 years
Adverse events (AE)
Up to 5 years
Study Arms (2)
Experimental group
EXPERIMENTALExperimental 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)
Control group
ACTIVE COMPARATORControl 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
Interventions
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
Eligibility Criteria
You may qualify if:
- Male/female who are at least 18 years of age on the day of signing the informed consent.
- With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
- Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
- 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.
- ECOG PS within 7 days before randomization: 0-1.
- Expected survival ≥ 6 months.
- Had adequate organ function
You may not qualify if:
- Patients with other malignant tumors within 2 years before the randomization.
- Evidence of disease progression within 6 months (before randomization) after completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
- Previous treatment with any HER2-target therapy.
- Active gastrointestinal bleeding
- Presence of central nervous system (CNS) metastases.
- Left ventricular ejection fraction (LVEF) \< 55%.
- Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Henlius Biotechlead
- Henlius USAcollaborator
Study Sites (208)
Los Angeles Cancer Network
Anaheim, California, 92801, United States
OPN - Oncology Physician Network (Los Alamitos)
Los Alamitos, California, 90720, United States
Banner MD Anderson Cancer Center
Greeley, Colorado, 80631, United States
Advanced Research LLC
Deerfield Beach, Florida, 33064, United States
Florida Cancer Specialist - South
Fort Myers, Florida, 33901, United States
BRCR Medical Center
Plantation, Florida, 33322, United States
Napa Research
Pompano Beach, Florida, 33064, United States
Florida Cancer Specialist - North
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialist - East
West Palm Beach, Florida, 33401, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Mission Cancer + Blood (Exigent Network)
Des Moines, Iowa, 50309, United States
Holden Comprehensive Cancer Center - University of Iowa
Iowa City, Iowa, 52242, United States
Washington University School of Medicine St. Louis
St Louis, Missouri, 63110, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Comprehensive Cancer Centers Nevada
Las Vegas, Nevada, 89169, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Guthrie Medical Group, PC and Robert Packer Hospital (Guthrie Cancer Center - Sayre)
Sayre, Pennsylvania, 18840, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
HCA Midwest Health
Nashville, Tennessee, 60637, United States
Texas Oncology - West (SCRI)
Abilene, Texas, 79606, United States
Texas Oncology Central South (SCRI)
Austin, Texas, 78705, United States
Texas Oncology Northeast (SCRI)
Denton, Texas, 76201, United States
The University of Texas MD Anderson cancer Center
Houston, Texas, 77030, United States
Texas Oncology - Gulf Coast (SCRI)
Webster, Texas, 77598, United States
American Oncology Network Vista Oncology Division
Olympia, Washington, 98502, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, 26506, United States
Centro de Investigacion Pergamino SA
Buenos Aires, Buenos Aires, B2700, Argentina
União Brasileira de Educação e Assistência
Puerto Alegre, RS, 90610000, Argentina
Centro de Investigaciones Clinicas. Clinica Viedma S.A.
Viedma, Río Negro Province, 8500, Argentina
Instituto de Oncologia de Rosario
Cordoba, Santa Fe Province, 2000, Argentina
Centro Médico Privado CEMAIC
Cordoba, Santa Fe Province, X5008HHW, Argentina
Sanatorio Plaza - Fundacion Pita
Rosario, Santa Fe Province, 2000, Argentina
Sanatorio de la Mujer
Rosario, Santa Fe Province, S2013, Argentina
Beneficência Portuguesa de São Paulo
San Pablo, SP, 01321-001, Argentina
Fundacion CENIT
Buenos Aires, 1125, Argentina
IONC Instituto Oncologico de Cordoba
Córdoba, 5000, Argentina
Instituto San Marcos
San Juan, J5400 EBB, Argentina
CER - Centro de Rehabilitacion Medica San Juan
San Juan, J5402 DIL, Argentina
Exelsus
San Miguel de Tucumán, 4000, Argentina
St. Vincent Hospital Melbourne
Fitzroy, Melbourne, 3065, Australia
Peninsula Health-Frankston hospital
Frankston, Melbourne, 3940, Australia
University of the Sunshine Coast Clinical Trials, Sunshine Coast Haematology and Oncology Clinic
Sunshine Coast, Queensland, 4556, Australia
GenesisCare Research
Campbelltown, Sydney, 2560, Australia
Central Coast Local Health District (Gosford and Wyong Hospital)
Gosford, Sydney, 2250, Australia
Macquarie University
North Ryde, Sydney, 2109, Australia
Concord Repatriation General Hospital
Concord, Sydney, Australia
Personal Oncologia de Precisio e Personalizada
Belo Horizonte, Minas Gerais, 30130 090, Brazil
Instituto de Oncologia do Paraná - IOP Pequisa
Curitiba, Paraná (PR), 82305-100, Brazil
Real Hospital de Beneficencia Portuguesa
Recife, Pernambuco, 52010-075, Brazil
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Centro Gaúcho Integrado - Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Clinica de Hematologia e Oncologia Viver
Santa Maria, Rio Grande Do Sul (RS), 97015-450, Brazil
ANIMI - Unidade de Tratamento Oncologico
Lages, Santa Catarina, 88501-003, Brazil
Brazilian Institute for Cancer Control (IBCC)
Vila Mariana, São Paulo, 04014-002, Brazil
Hospital Santa Marcelina HSM
São Paulo, 08270-120, Brazil
Centro de Oncologia de Precision
Santiago, Santiago Metropolitan, 7560908, Chile
Instituto del Cancer RedSalud Vitacura
Santiago, Santiago Metropolitan, 7630000, Chile
Icegclinic
Santiago, 8240000, Chile
Fundacion Arturo Lopez Perez
Santiago, 99010-080, Chile
Affiliated Hospital of Youjiang Medical University for Nationalities
Baise City, China
Beijing Cancer Hospital
Beijing, 100142, 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
Shanxi Cancer Hospital
Taiyuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Cancer Hospital Affiliated to Xinjiang Medical University
Ürümqi, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Qinghai University Affiliated Hospital
Xining, China
Xuzhou Central Hospital
Xuzhou, China
Yichang Central People's Hospital
Yichang, China
General Hospital of Ningxia Medical University
Yinchuan, China
Henan Cancer Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
LLC Todua Clinic
Tbilisi, 112, Georgia
Ltd "New Hospitals"
Tbilisi, 114, Georgia
Tbilisi State Medical University and Ingorovka High Medical Technology University Clinic Ltd
Tbilisi, 114, Georgia
JSV VIAN- Caraps Medline
Tbilisi, 159, Georgia
Evex Hospitals - Caucasus Medical Center
Tbilisi, 186, Georgia
Klinikum St. Marien Amberg
Amberg, 92224, Germany
Evangelisches Krankenhaus Bielefeld gGmbH (EvKB)
Bielefeld, 33611, Germany
Universitaetsklinikum Carl-Gustav-Carus
Dresden, 1307, Germany
Hamatologisch-Onkologischen Praxis Eppendorf (HOPE)
Hamburg, 20249, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, 74078, Germany
Kreiskliniken Reutlingen gGmbH
Reutlingen, 72764, Germany
Agios Savvas Cancer Hospital (Saint Savvas Regional Anticancer Oncology Hospital of Athens)
Athens, 11522, Greece
Medical Center, Psychiko Clinic
Athens, 11527, Greece
Sotiria General Hospital of Chest Diseases
Athens, 11527, Greece
Agioi Anargiroi General Oncology Hospital of Kifissia
Kifissia, 14564, Greece
Papageorgiou General Hospital
Thessaloniki, 56429, Greece
Azienda Ospedaliera San Sebastiano di Caserta
Caserta, 81100, Italy
ASST Cremona
Cremona, 80131, Italy
Universita degli Studi della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria
Naples, 80131, Italy
Gruppo Humanitas - Humanitas Research Hospital (Istituto Clinico Humanitas)
Rozzano, 20089, Italy
Instituto di Ricovero e Cura a Carattere Scientifico (IRCCS)
San Giovanni Rotondo, 71013, Italy
Azienda Ospedaliero Universitaria delle Marche
Torrette, 60126, Italy
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) (Azienda Sanitaria Universitaria Integrata di Udine) (ASUIUD) (AOU Santa Maria della Misericordia di Udine) (AAS4 Friuli Centrale)
Udine, 33100, Italy
Hyogo Cancer Center
Akashi-shi, Hyōgo, Japan
Kagawa University Hospital
Takamatsu, Kagawa-ken, Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
National Hospital Organization Osaka National Hospital
Chuo-ku Osaka-shi, Japan
Gifu University Hospital
Gifu, Japan
Hamamatsu University Hospital
Hamamatsu, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan
Izumi City General Hospital
Izumi-shi, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Japan
Ibaraki Prefectural Central Hospital, Ibaraki Cancer Center
Kasama-shi, Japan
The Cancer Institute Hospital of JFCR
Kōtoku, Japan
Gunma University Hospital
Maebashi, Japan
Osaka International Cancer Institute
Osaka, Japan
Osaka Keisatsu Hospital
Osaka, Japan
Osaki Citizen Hospital
Osaki-shi, Japan
Saitama Cancer Center
Saitama, Japan
Hokkaido University Hospital
Sapporo, Japan
Keiyukai Sapporo Hospital
Sapporo, Japan
Teine Keijinkai Hospital
Sapporo, Japan
Shizuoka General Hospital
Shizuoka, Japan
Suita Municipal Hospital
Suita, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi, Japan
Toyonaka Municipal Hospital
Toyonaka-shi, Japan
Tochigi Cancer Center
Utsunomiya, Japan
Wakayama Medical University Hospital
Wakayama, Japan
Yamagata Prefectural Central Hospital
Yamagata, Japan
Centro Especializado en Oncologia de Precision
Lima, Peru
Instiruto Nacional de Enfermedades Neoplasicas
Lima, Peru
Institutto Peruano de Oncologia y Radioterapia
San Isidro, Peru
Szpital Specjalistyczny Podkarpacki Osrodek Onkologiczny w Brzozowie
Brzozów, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika
Koszalin, Poland
IP Clinic
Lodz, Poland
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
Lublin, Poland
AidPort, Osrodek Badan Klinicznych
Otwock, Poland
Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
Skorzewo, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w S?upsku Sp. z o.o.
Słupsk, Poland
Maria Sklodowska-Curie National Cancer Research Institute
Warsaw, Poland
Panstwowy Instytut Medyczny MSWiA
Warsaw, Poland
Regional Institute of Gastroenterology and Hepatology
Cluj-Napoca, Romania
Clinica Amethyst Radiotherapy
Craiova, Romania
Centrul de Oncologie Sfantu Nectarie
Floreşti, Romania
Spitalul Pelican
Oradea, Romania
Sc Sigmedical Srl
Suceava, Romania
Chungbuk National University Hospital
Cheongju-si, South Korea
Jeonbuk National University Hospital
Cheongju-si, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Asan Medical Center
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Hospital del Mar
Barcelona, Spain
Institut Catala di Oncologia - Hospital Duran i Reynals
Barcelona, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Hospital Alvaro Cunqueiro
Vigo, Spain
Baskent University Adana Dr Turgut Noyan Research and Application Center
Adana, Turkey (Türkiye)
Medical Park Seyhan Hospital
Adana, Turkey (Türkiye)
Ankara City Hospital
Ankara, Turkey (Türkiye)
Ankara University Medicine Faculty Cebeci Hospital
Ankara, Turkey (Türkiye)
Dicle University Medical Faculty Oncology Hospital
Diyarbakır, Turkey (Türkiye)
Balkan Oncology Hospital, Trakya University
Edirne, Turkey (Türkiye)
Ataturk University Faculty Of Medicine Research Hospital Medical Oncology
Erzurum, Turkey (Türkiye)
Kayseri Memorial Hospital
Kayseri, Turkey (Türkiye)
Kocaeli University Hospital
Kocaeli, Turkey (Türkiye)
Sakarya Training and Research Hospital
Sakarya, Turkey (Türkiye)
Tekirdag namik kemal university hospital medical oncology klinik
Tekirdağ, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2024
First Posted
August 1, 2024
Study Start
November 22, 2024
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
September 1, 2028
Last Updated
February 27, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share