A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

February 24, 2026 updated by: Shanghai Henlius Biotech

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

550

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1125
        • Recruiting
        • Fundacion Cenit
      • Córdoba, Argentina, 5000
        • Recruiting
        • Ionc Instituto Oncologico De Cordoba
      • San Juan, Argentina, J5400 EBB
        • Recruiting
        • Instituto San Marcos
      • San Juan, Argentina, J5402 DIL
        • Recruiting
        • CER - Centro de Rehabilitacion Medica San Juan
      • San Miguel de Tucumán, Argentina, 4000
        • Recruiting
        • Exelsus
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, B2700
        • Recruiting
        • Centro de Investigación Pergamino SA
    • RS
      • Puerto Alegre, RS, Argentina, 90610000
        • Recruiting
        • União Brasileira de Educação e Assistência
    • Río Negro Province
      • Viedma, Río Negro Province, Argentina, 8500
        • Recruiting
        • Centro de Investigaciones Clinicas. Clinica Viedma S.A.
    • SP
      • San Pablo, SP, Argentina, 01321-001
        • Recruiting
        • Beneficencia Portuguesa de Sao Paulo
    • Santa Fe Province
      • Cordoba, Santa Fe Province, Argentina, 2000
        • Recruiting
        • Instituto de Oncologia de Rosario
      • Cordoba, Santa Fe Province, Argentina, X5008HHW
        • Not yet recruiting
        • Centro médico privado Cemaic
      • Rosario, Santa Fe Province, Argentina, 2000
        • Recruiting
        • Sanatorio Plaza - Fundacion Pita
      • Rosario, Santa Fe Province, Argentina, S2013
        • Recruiting
        • Sanatorio de la Mujer
  • Australia
      • Concord, Australia, Sydney
        • Recruiting
        • Concord Repatriation General Hospital
    • Melbourne
      • Fitzroy, Melbourne, Australia, 3065
        • Recruiting
        • St. Vincent Hospital Melbourne
      • Frankston, Melbourne, Australia, 3940
        • Recruiting
        • Peninsula Health-Frankston Hospital
    • Queensland
      • Sunshine Coast, Queensland, Australia, 4556
        • Recruiting
        • University of the Sunshine Coast Clinical Trials, Sunshine Coast Haematology and Oncology Clinic
    • Sydney
      • Campbelltown, Sydney, Australia, 2560
        • Recruiting
        • GenesisCare Research
      • Gosford, Sydney, Australia, 2250
        • Recruiting
        • Central Coast Local Health District (Gosford and Wyong Hospital)
      • North Ryde, Sydney, Australia, 2109
        • Recruiting
        • Macquarie University
  • Brazil
      • São Paulo, Brazil, 08270-120
        • Recruiting
        • Hospital Santa Marcelina HSM
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130 090
        • Recruiting
        • Personal Oncologia de Precisio e Personalizada
    • Paraná (PR)
      • Curitiba, Paraná (PR), Brazil, 82305-100
        • Recruiting
        • Instituto de Oncologia do Paraná - IOP Pequisa
    • Pernambuco
      • Recife, Pernambuco, Brazil, 52010-075
        • Recruiting
        • Real Hospital de Beneficencia Portuguesa
    • Rio Grande Do Sul (RS)
      • Santa Maria, Rio Grande Do Sul (RS), Brazil, 97015-450
        • Recruiting
        • Clinica de Hematologia e Oncologia Viver
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre (HCPA)
      • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
        • Recruiting
        • Centro Gaúcho Integrado - Hospital Mae de Deus
    • Santa Catarina
      • Lages, Santa Catarina, Brazil, 88501-003
        • Recruiting
        • ANIMI - Unidade de Tratamento Oncologico
    • São Paulo
      • Vila Mariana, São Paulo, Brazil, 04014-002
        • Recruiting
        • Brazilian Institute for Cancer Control (IBCC)
  • Chile
      • Santiago, Chile, 8240000
        • Recruiting
        • Icegclinic
      • Santiago, Chile, 99010-080
        • Recruiting
        • Fundacion Arturo Lopez Perez
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7560908
        • Recruiting
        • Centro de Oncología de Precisión
      • Santiago, Santiago Metropolitan, Chile, 7630000
        • Recruiting
        • Instituto del Cancer RedSalud Vitacura
  • China
      • Baise City, China
        • Recruiting
        • Affiliated Hospital of Youjiang Medical University for Nationalities
      • Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Principal Investigator:
          • Lin Shen
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
      • Beijing, China
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
      • Bengbu, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical University
      • Changchun, China
        • Recruiting
        • The First Hospital of Jilin University
      • Changsha, China
        • Recruiting
        • Hunan Cancer Hospital
      • Changzhi, China
        • Recruiting
        • Heping Hospital Affiliated to Changzhi Medical College
      • Changzhou, China
        • Recruiting
        • The First People's Hospital of Changzhou
      • Chengdu, China
        • Recruiting
        • West China Hospital of Sichuan University
      • Chengdu, China
        • Recruiting
        • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
      • Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
      • Dezhou, China
        • Recruiting
        • Dezhou Second People's hospital
      • Fuzhou, China
        • Recruiting
        • Fujian Cancer Hospital
      • Guangdong, China
        • Recruiting
        • Zhongshan City People's Hospital
      • Guangzhou, China
        • Recruiting
        • The sixth affiliated hospital of Sun Yat-Sen University
      • Hangzhou, China
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medic
      • Hangzhou, China
        • Recruiting
        • Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
      • Harbin, China
        • Recruiting
        • Harbin Medical University Cancer Hospital
      • Hefei, China
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei, China
        • Recruiting
        • The Second Hospital of Anhui Medical University
      • Jinan, China
        • Recruiting
        • Cancer Hospital of Shandong First Medical University
      • Lanzhou, China
        • Recruiting
        • The First Hospital of Lanzhou University
      • Lanzhou, China
        • Recruiting
        • Gansu Provincial Hospital
      • Lanzhou, China
        • Recruiting
        • Gansu Provincial Cancer Hospital
      • Lanzhou, China
        • Recruiting
        • Gansu Wuwei Tumour Hospital
      • Liuchow, China
        • Recruiting
        • Liuzhou Workers' Hospital
      • Luoyang, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science
      • Mianyang, China
        • Recruiting
        • Mianyang Central Hospital
      • Nanchang, China
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
      • Nanjing, China
        • Recruiting
        • Nanjing Drum Tower Hospital
      • Nanjing, China
        • Recruiting
        • Jiangsu Province Hospital
      • Qingdao, China
        • Recruiting
        • The affiliated hospital of Qingdao university
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
      • Shanghai, China
        • Recruiting
        • Renji Hospital,Shanghai Jiao Tong University School of Medicine
      • Shaoyang, China
        • Recruiting
        • The Central Hospital of Shaoyang
      • Shenyang, China
        • Recruiting
        • Liaoning Medical University Cancer Institute & Hospital
      • Shijia Zhuang, China
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
      • Taiyuan, China
        • Recruiting
        • Shanxi Cancer Hospital
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
      • Xiamen, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
      • Xining, China
        • Recruiting
        • Qinghai University Affiliated Hospital
      • Xuzhou, China
        • Recruiting
        • Xuzhou Central Hospital
      • Yichang, China
        • Recruiting
        • Yichang Central People's Hospital
      • Yinchuan, China
        • Recruiting
        • General Hospital of Ningxia Medical University
      • Zhengzhou, China
        • Recruiting
        • Henan Cancer Hospital
      • Zhengzhou, China
        • Recruiting
        • the First Affiliated Hospital of Zhengzhou University
      • Ürümqi, China
        • Recruiting
        • Cancer Hospital affiliated to Xinjiang Medical University
  • Georgia
      • Tbilisi, Georgia, 112
        • Recruiting
        • Llc Todua Clinic
      • Tbilisi, Georgia, 186
        • Recruiting
        • Evex Hospitals - Caucasus Medical Center
      • Tbilisi, Georgia, 114
        • Recruiting
        • Ltd "New Hospitals"
      • Tbilisi, Georgia, 114
        • Recruiting
        • Tbilisi State Medical University and Ingorovka High Medical Technology University Clinic Ltd
      • Tbilisi, Georgia, 159
        • Recruiting
        • JSV VIAN- Caraps Medline
  • Germany
      • Amberg, Germany, 92224
        • Recruiting
        • Klinikum St. Marien Amberg
      • Bielefeld, Germany, 33611
        • Recruiting
        • Evangelisches Krankenhaus Bielefeld gGmbH (EvKB)
      • Dresden, Germany, 1307
        • Recruiting
        • Universitaetsklinikum Carl-Gustav-Carus
      • Hamburg, Germany, 20249
        • Recruiting
        • Hamatologisch-Onkologischen Praxis Eppendorf (HOPE)
      • Hanover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
      • Heilbronn, Germany, 74078
        • Recruiting
        • SLK-Kliniken Heilbronn GmbH
      • Reutlingen, Germany, 72764
        • Recruiting
        • Kreiskliniken Reutlingen gGmbH
  • Greece
      • Athens, Greece, 11527
        • Recruiting
        • Sotiria General Hospital of Chest Diseases
      • Athens, Greece, 11522
        • Recruiting
        • Agios Savvas Cancer Hospital (Saint Savvas Regional Anticancer Oncology Hospital of Athens)
      • Athens, Greece, 11527
        • Recruiting
        • Medical Center, Psychiko Clinic
      • Kifissia, Greece, 14564
        • Recruiting
        • Agioi Anargiroi General Oncology Hospital of Kifissia
      • Thessaloniki, Greece, 56429
        • Recruiting
        • Papageorgiou General Hospital
  • Italy
      • Caserta, Italy, 81100
        • Recruiting
        • Azienda Ospedaliera San Sebastiano di Caserta
      • Cremona, Italy, 80131
        • Recruiting
        • ASST Cremona
      • Napoli, Italy, 80131
        • Recruiting
        • Universita Degli Studi Della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria
      • Rozzano, Italy, 20089
        • Recruiting
        • Gruppo Humanitas - Humanitas Research Hospital (Istituto Clinico Humanitas)
      • San Giovanni Rotondo, Italy, 71013
        • Recruiting
        • Instituto di Ricovero e Cura a Carattere Scientifico (IRCCS)
      • Torrette, Italy, 60126
        • Recruiting
        • Azienda Ospedaliero Universitaria delle Marche
      • Udine, Italy, 33100
        • Recruiting
        • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) (Azienda Sanitaria Universitaria Integrata di Udine) (ASUIUD) (AOU Santa Maria della Misericordia di Udine) (AAS4 Friuli Centrale)
  • Japan
      • Chuo-ku Osaka-shi, Japan
        • Recruiting
        • National Hospital Organization Osaka National Hospital
      • Gifu, Japan
        • Recruiting
        • Gifu University Hospital
      • Hamamatsu, Japan
        • Recruiting
        • Hamamatsu University Hospital
      • Hiroshima, Japan
        • Recruiting
        • Hiroshima City Hiroshima Citizens Hospital
      • Izumi-shi, Japan
        • Recruiting
        • Izumi City General Hospital
      • Kanazawa, Japan
        • Recruiting
        • Ishikawa Prefectural Central Hospital
      • Kasama-shi, Japan
        • Recruiting
        • Ibaraki Prefectural Central Hospital, Ibaraki Cancer Center
      • Kōtoku, Japan
        • Recruiting
        • The Cancer Institute Hospital Of JFCR
      • Maebashi, Japan
        • Recruiting
        • Gunma University Hospital
      • Osaka, Japan
        • Recruiting
        • Osaka International Cancer Institute
      • Osaka, Japan
        • Recruiting
        • Osaka Keisatsu Hospital
      • Osaki-shi, Japan
        • Recruiting
        • Osaki Citizen Hospital
      • Saitama, Japan
        • Recruiting
        • Saitama Cancer Center
      • Sapporo, Japan
        • Recruiting
        • Hokkaido University Hospital
      • Sapporo, Japan
        • Recruiting
        • Teine Keijinkai Hospital
      • Sapporo, Japan
        • Recruiting
        • Keiyukai Sapporo Hospital
      • Shizuoka, Japan
        • Recruiting
        • Shizuoka General Hospital
      • Suita, Japan
        • Recruiting
        • Suita Municipal Hospital
      • Takatsuki-shi, Japan
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital
      • Toyonaka-shi, Japan
        • Recruiting
        • Toyonaka Municipal Hospital
      • Utsunomiya, Japan
        • Recruiting
        • Tochigi Cancer Center
      • Wakayama, Japan
        • Recruiting
        • Wakayama Medical University Hospital
      • Yamagata, Japan
        • Recruiting
        • Yamagata Prefectural Central Hospital
    • Hyōgo
      • Akashi-shi, Hyōgo, Japan
        • Recruiting
        • Hyogo Cancer Center
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, Japan
        • Recruiting
        • Kagawa University Hospital
    • Tokyo
      • Chuo Ku, Tokyo, Japan
        • Recruiting
        • National Cancer Center Hospital
  • Peru
      • Lima, Peru
        • Recruiting
        • Centro Especializado en Oncologia de Precision
      • Lima, Peru
        • Recruiting
        • Instiruto Nacional de Enfermedades Neoplasicas
      • San Isidro, Peru
        • Recruiting
        • Institutto Peruano de Oncologia y Radioterapia
  • Poland
      • Brzozów, Poland
        • Recruiting
        • Szpital Specjalistyczny Podkarpacki Osrodek Onkologiczny w Brzozowie
      • Gdansk, Poland
        • Enrolling by invitation
        • Uniwersyteckie Centrum Kliniczne
      • Koszalin, Poland
        • Recruiting
        • Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika
      • Lodz, Poland
        • Recruiting
        • IP Clinic
      • Lublin, Poland
        • Recruiting
        • Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
      • Otwock, Poland
        • Recruiting
        • AidPort, Osrodek Badan Klinicznych
      • Skorzewo, Poland
        • Recruiting
        • Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
      • Słupsk, Poland
        • Recruiting
        • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w S?upsku Sp. z o.o.
      • Warsaw, Poland
        • Recruiting
        • Maria Sklodowska-Curie National Cancer Research Institute
      • Warsaw, Poland
        • Recruiting
        • PANSTWOWY INSTYTUT MEDYCZNY MSWiA
  • Romania
      • Cluj-Napoca, Romania
        • Recruiting
        • Regional Institute of Gastroenterology and Hepatology
      • Craiova, Romania
        • Recruiting
        • Clinica Amethyst Radiotherapy
      • Floreşti, Romania
        • Recruiting
        • Centrul de Oncologie Sfantu Nectarie
      • Oradea, Romania
        • Recruiting
        • Spitalul Pelican
      • Suceava, Romania
        • Recruiting
        • Sc Sigmedical Srl
  • South Korea
      • Cheongju-si, South Korea
        • Recruiting
        • Chungbuk National University Hospital
      • Cheongju-si, South Korea
        • Recruiting
        • Jeonbuk National University Hospital
      • Jinju, South Korea
        • Recruiting
        • Gyeongsang National University Hospital
      • Seoul, South Korea
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
      • Seoul, South Korea
        • Recruiting
        • Korea University Guro Hospital
      • Seoul, South Korea
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea
        • Recruiting
        • Korea University Anam Hospital
      • Seoul, South Korea
        • Recruiting
        • Kangbuk Samsung Hospital
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital del Mar
      • Barcelona, Spain
        • Recruiting
        • Institut Catala di Oncologia - Hospital Duran i Reynals
      • Madrid, Spain
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Paz
      • Majadahonda, Spain
        • Recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Oviedo, Spain
        • Recruiting
        • Hospital Universitario Central de Asturias
      • Seville, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain
        • Recruiting
        • Hospital Clinico Universitario de Valencia
      • Vigo, Spain
        • Recruiting
        • Hospital Álvaro Cunqueiro
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye)
        • Recruiting
        • Medical Park Seyhan Hospital
      • Adana, Turkey (Türkiye)
        • Recruiting
        • Baskent University Adana Dr Turgut Noyan Research and Application Center
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Ankara City Hospital
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Ankara University Medicine Faculty Cebeci Hospital
      • Diyarbakır, Turkey (Türkiye)
        • Recruiting
        • Dicle University Medical Faculty Oncology Hospital
      • Edirne, Turkey (Türkiye)
        • Recruiting
        • Balkan Oncology Hospital, Trakya University
      • Erzurum, Turkey (Türkiye)
        • Recruiting
        • Ataturk University Faculty Of Medicine Research Hospital Medical Oncology
      • Kayseri, Turkey (Türkiye)
        • Recruiting
        • Kayseri Memorial Hospital
      • Kocaeli, Turkey (Türkiye)
        • Recruiting
        • Kocaeli University Hospital
      • Sakarya, Turkey (Türkiye)
        • Recruiting
        • Sakarya Training and Research Hospital
      • Tekirdağ, Turkey (Türkiye)
        • Recruiting
        • Tekirdag namik kemal university hospital medical oncology klinik
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Recruiting
        • Los Angeles Cancer Network
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • OPN - Oncology Physician Network (Los Alamitos)
    • Colorado
      • Greeley, Colorado, United States, 80631
        • Recruiting
        • Banner MD Anderson Cancer Center
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Recruiting
        • Advanced Research LLC
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialist - South
      • Plantation, Florida, United States, 33322
        • Recruiting
        • BRCR Medical Center
      • Pompano Beach, Florida, United States, 33064
        • Recruiting
        • NAPA Research
      • St. Petersburg, Florida, United States, 33705
        • Recruiting
        • Florida Cancer Specialist - North
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Florida Cancer Specialist - East
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Mission Cancer + Blood (Exigent Network)
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Holden Comprehensive Cancer Center - University of Iowa
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine St. Louis
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Nebraska Cancer Specialists
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers Nevada
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center
      • Sayre, Pennsylvania, United States, 18840
        • Recruiting
        • Guthrie Medical Group, PC and Robert Packer Hospital (Guthrie Cancer Center - Sayre)
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 60637
        • Recruiting
        • HCA Midwest Health
    • Texas
      • Abilene, Texas, United States, 79606
        • Recruiting
        • Texas Oncology - West (SCRI)
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Oncology Central South (SCRI)
      • Denton, Texas, United States, 76201
        • Recruiting
        • Texas Oncology Northeast (SCRI)
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
      • Webster, Texas, United States, 77598
        • Recruiting
        • Texas Oncology - Gulf Coast (SCRI)
    • Washington
      • Olympia, Washington, United States, 98502
        • Recruiting
        • American Oncology Network Vista Oncology Division
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Northwest Medical Specialties
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male/female who are at least 18 years of age on the day of signing the informed consent.
  2. With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
  3. Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
  4. 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.
  5. ECOG PS within 7 days before randomization: 0-1.
  6. Expected survival ≥ 6 months.
  7. Had adequate organ function

Exclusion Criteria:

  1. Patients with other malignant tumors within 2 years before the randomization.
  2. 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.
  3. Previous treatment with any HER2-target therapy.
  4. Active gastrointestinal bleeding
  5. Presence of central nervous system (CNS) metastases.
  6. Left ventricular ejection fraction (LVEF) < 55%.
  7. Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group

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
HLX22 15mg/kg Q3w
Drug: Trastuzumab
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
Drug: Oxaliplatin
Oxaliplatin 130 mg/m2 ,Q3W
Drug: Capecitabine
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W
Active Comparator: Control group

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: Trastuzumab
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
Drug: Oxaliplatin
Oxaliplatin 130 mg/m2 ,Q3W
Drug: Capecitabine
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W
Drug: Pembrolizumab
Pembrolizumab 200mg q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)
Time Frame: Up to 5 years
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）
Time Frame: Up to 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS per RECIST 1.1 assessed by investigator
Time Frame: Up to 5 years
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
Objective Response Rate (ORR) assessed by IRRC and investigator per RECIST v1.1
Time Frame: Up to 5 years
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.
Up to 5 years
Adverse events (AE)
Time Frame: Up to 5 years
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.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Henlius Biotech

Collaborators

Henlius USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLX22-GC-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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