AzTrials
AzTrials

Gastroesophageal-junction CancerPhase 3NCT06532006

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

A Phase 3 study testing HLX22, Pembrolizumab and Trastuzumab in people with Gastroesophageal-junction Cancer and Monoclonal Antibody, run by Shanghai Henlius Biotech at 208 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HLX22, Pembrolizumab and Trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
208 sitesin 17 countries
Study dates
22 Nov 2024to 1 Sep 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

208 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Ying Li contact

+86 18810366427

ying_li1@henlius.com

208 sites in 17 countries

China48 sites, 48 recruiting

  • Affiliated Hospital of Youjiang Medical University for Nationalities

    Baise City

    Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Lin Shen

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

    Recruiting

  • Peking Union Medical College Hospital

    Beijing

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu

    Recruiting

  • The First Hospital of Jilin University

    Changchun

    Recruiting

  • Hunan Cancer Hospital

    Changsha

    Recruiting

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi

    Recruiting

  • The First People's Hospital of Changzhou

    Changzhou

    Recruiting

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

    Recruiting

  • Dezhou Second People's hospital

    Dezhou

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Recruiting

  • Zhongshan City People's Hospital

    Guangdong

    Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou

    Recruiting

  • Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine

    Hangzhou

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medic

    Hangzhou

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

    Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan

    Recruiting

  • Gansu Provincial Cancer Hospital

    Lanzhou

    Recruiting

  • Gansu Provincial Hospital

    Lanzhou

    Recruiting

  • Gansu Wuwei Tumour Hospital

    Lanzhou

    Recruiting

  • The First Hospital Of Lanzhou University

    Lanzhou

    Recruiting

  • Liuzhou Workers' Hospital

    Liuzhou

    Recruiting

  • The First Affiliated Hospital of Henan University of Science

    Luoyang

    Recruiting

  • Mianyang Central Hospital

    Mianyang

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Recruiting

  • Jiangsu Province Hospital

    Nanjing

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Recruiting

  • Renji Hospital,Shanghai Jiao Tong University School of Medicine

    Shanghai

    Recruiting

  • The Central Hospital of Shaoyang

    Shaoyang

    Recruiting

  • Liaoning Medical University Cancer Institute & Hospital

    Shenyang

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijia Zhuang

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Recruiting

  • Cancer Hospital Affiliated to Xinjiang Medical University

    Ürümqi

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen

    Recruiting

  • Qinghai University Affiliated Hospital

    Xining

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou

    Recruiting

  • Yichang Central People's Hospital

    Yichang

    Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Recruiting

Other trials in China

United States29 sites, 29 recruiting

  • Texas Oncology - West (SCRI)

    Abilene, Texas, 79606

    Recruiting

  • Los Angeles Cancer Network

    Anaheim, California, 92801

    Recruiting

  • Texas Oncology Central South (SCRI)

    Austin, Texas, 78705

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Recruiting

  • Advanced Research LLC

    Deerfield Beach, Florida, 33064

    Recruiting

  • Texas Oncology Northeast (SCRI)

    Denton, Texas, 76201

    Recruiting

  • Mission Cancer + Blood (Exigent Network)

    Des Moines, Iowa, 50309

    Recruiting

  • Florida Cancer Specialist - South

    Fort Myers, Florida, 33901

    Recruiting

  • Banner MD Anderson Cancer Center

    Greeley, Colorado, 80631

    Recruiting

  • The University of Texas MD Anderson cancer Center

    Houston, Texas, 77030

    Recruiting

  • Holden Comprehensive Cancer Center - University of Iowa

    Iowa City, Iowa, 52242

    Recruiting

  • Comprehensive Cancer Centers Nevada

    Las Vegas, Nevada, 89169

    Recruiting

  • OPN - Oncology Physician Network (Los Alamitos)

    Los Alamitos, California, 90720

    Recruiting

  • West Virginia University Cancer Institute

    Morgantown, West Virginia, 26506

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Recruiting

  • HCA Midwest Health

    Nashville, Tennessee, 60637

    Recruiting

  • American Oncology Network Vista Oncology Division

    Olympia, Washington, 98502

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • BRCR Medical Center

    Plantation, Florida, 33322

    Recruiting

  • Napa Research

    Pompano Beach, Florida, 33064

    Recruiting

  • Guthrie Medical Group, PC and Robert Packer Hospital (Guthrie Cancer Center - Sayre)

    Sayre, Pennsylvania, 18840

    Recruiting

  • Washington University School of Medicine St. Louis

    St Louis, Missouri, 63110

    Recruiting

  • Florida Cancer Specialist - North

    St. Petersburg, Florida, 33705

    Recruiting

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

    Recruiting

  • Texas Oncology - Gulf Coast (SCRI)

    Webster, Texas, 77598

    Recruiting

  • Florida Cancer Specialist - East

    West Palm Beach, Florida, 33401

    Recruiting

Other trials in United States

Japan26 sites, 26 recruiting

  • Hyogo Cancer Center

    Akashi-shi, Hyōgo

    Recruiting

  • National Cancer Center Hospital

    Chuo Ku, Tokyo

    Recruiting

  • National Hospital Organization Osaka National Hospital

    Chuo-ku Osaka-shi

    Recruiting

  • Gifu University Hospital

    Gifu

    Recruiting

  • Hamamatsu University Hospital

    Hamamatsu

    Recruiting

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima

    Recruiting

  • Izumi City General Hospital

    Izumi-shi

    Recruiting

  • Ishikawa Prefectural Central Hospital

    Kanazawa

    Recruiting

  • Ibaraki Prefectural Central Hospital, Ibaraki Cancer Center

    Kasama-shi

    Recruiting

  • The Cancer Institute Hospital of JFCR

    Kōtoku

    Recruiting

  • Gunma University Hospital

    Maebashi

    Recruiting

  • Osaka International Cancer Institute

    Osaka

    Recruiting

  • Osaka Keisatsu Hospital

    Osaka

    Recruiting

  • Osaki Citizen Hospital

    Osaki-shi

    Recruiting

  • Saitama Cancer Center

    Saitama

    Recruiting

  • Hokkaido University Hospital

    Sapporo

    Recruiting

  • Keiyukai Sapporo Hospital

    Sapporo

    Recruiting

  • Teine Keijinkai Hospital

    Sapporo

    Recruiting

  • Shizuoka General Hospital

    Shizuoka

    Recruiting

  • Suita Municipal Hospital

    Suita

    Recruiting

  • Kagawa University Hospital

    Takamatsu, Kagawa-ken

    Recruiting

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki-shi

    Recruiting

  • Toyonaka Municipal Hospital

    Toyonaka-shi

    Recruiting

  • Tochigi Cancer Center

    Utsunomiya

    Recruiting

  • Wakayama Medical University Hospital

    Wakayama

    Recruiting

  • Yamagata Prefectural Central Hospital

    Yamagata

    Recruiting

Other trials in Japan

Argentina13 sites, 13 recruiting

  • Centro de Investigacion Pergamino SA

    Buenos Aires, Buenos Aires, B2700

    Recruiting

  • Fundacion CENIT

    Buenos Aires, 1125

    Recruiting

  • Instituto de Oncologia de Rosario

    Cordoba, Santa Fe Province, 2000

    Recruiting

  • Centro Médico Privado CEMAIC

    Cordoba, Santa Fe Province, X5008HHW

    Not yet recruiting

  • IONC Instituto Oncologico de Cordoba

    Córdoba, 5000

    Recruiting

  • União Brasileira de Educação e Assistência

    Puerto Alegre, RS, 90610000

    Recruiting

  • Sanatorio Plaza - Fundacion Pita

    Rosario, Santa Fe Province, 2000

    Recruiting

  • Sanatorio de la Mujer

    Rosario, Santa Fe Province, S2013

    Recruiting

  • Instituto San Marcos

    San Juan, J5400 EBB

    Recruiting

  • CER - Centro de Rehabilitacion Medica San Juan

    San Juan, J5402 DIL

    Recruiting

  • Exelsus

    San Miguel de Tucumán, 4000

    Recruiting

  • Beneficência Portuguesa de São Paulo

    San Pablo, SP, 01321-001

    Recruiting

  • Centro de Investigaciones Clinicas. Clinica Viedma S.A.

    Viedma, Río Negro Province, 8500

    Recruiting

Other trials in Argentina

Turkey (Türkiye)11 sites, 11 recruiting

  • Baskent University Adana Dr Turgut Noyan Research and Application Center

    Adana

    Recruiting

  • Medical Park Seyhan Hospital

    Adana

    Recruiting

  • Ankara City Hospital

    Ankara

    Recruiting

  • Ankara University Medicine Faculty Cebeci Hospital

    Ankara

    Recruiting

  • Dicle University Medical Faculty Oncology Hospital

    Diyarbakır

    Recruiting

  • Balkan Oncology Hospital, Trakya University

    Edirne

    Recruiting

  • Ataturk University Faculty Of Medicine Research Hospital Medical Oncology

    Erzurum

    Recruiting

  • Kayseri Memorial Hospital

    Kayseri

    Recruiting

  • Kocaeli University Hospital

    Kocaeli

    Recruiting

  • Sakarya Training and Research Hospital

    Sakarya

    Recruiting

  • Tekirdag namik kemal university hospital medical oncology klinik

    Tekirdağ

    Recruiting

Other trials in Turkey (Türkiye)

Poland10 sites, 10 recruiting

  • Szpital Specjalistyczny Podkarpacki Osrodek Onkologiczny w Brzozowie

    Brzozów

    Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk

    Enrolling by invitation

  • Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika

    Koszalin

    Recruiting

  • IP Clinic

    Lodz

    Recruiting

  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie

    Lublin

    Recruiting

  • AidPort, Osrodek Badan Klinicznych

    Otwock

    Recruiting

  • Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.

    Skorzewo

    Recruiting

  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w S?upsku Sp. z o.o.

    Słupsk

    Recruiting

  • Maria Sklodowska-Curie National Cancer Research Institute

    Warsaw

    Recruiting

  • Panstwowy Instytut Medyczny MSWiA

    Warsaw

    Recruiting

Other trials in Poland

South Korea10 sites, 10 recruiting

  • Chungbuk National University Hospital

    Cheongju-si

    Recruiting

  • Jeonbuk National University Hospital

    Cheongju-si

    Recruiting

  • Gyeongsang National University Hospital

    Jinju

    Recruiting

  • Asan Medical Center

    Seoul

    Recruiting

  • Kangbuk Samsung Hospital

    Seoul

    Recruiting

  • Korea University Anam Hospital

    Seoul

    Recruiting

  • Korea University Guro Hospital

    Seoul

    Recruiting

  • Samsung Medical Center

    Seoul

    Recruiting

  • Seoul National University Hospital

    Seoul

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul

    Recruiting

Other trials in South Korea

Brazil9 sites, 9 recruiting

  • Personal Oncologia de Precisio e Personalizada

    Belo Horizonte, Minas Gerais, 30130 090

    Recruiting

  • Instituto de Oncologia do Paraná - IOP Pequisa

    Curitiba, Paraná (PR), 82305-100

    Recruiting

  • ANIMI - Unidade de Tratamento Oncologico

    Lages, Santa Catarina, 88501-003

    Recruiting

  • Hospital de Clinicas de Porto Alegre (HCPA)

    Porto Alegre, Rio Grande do Sul, 90035-903

    Recruiting

  • Centro Gaúcho Integrado - Hospital Mãe de Deus

    Porto Alegre, Rio Grande do Sul, 90110-270

    Recruiting

  • Real Hospital de Beneficencia Portuguesa

    Recife, Pernambuco, 52010-075

    Recruiting

  • Clinica de Hematologia e Oncologia Viver

    Santa Maria, Rio Grande Do Sul (RS), 97015-450

    Recruiting

  • Hospital Santa Marcelina HSM

    São Paulo, 08270-120

    Recruiting

  • Brazilian Institute for Cancer Control (IBCC)

    Vila Mariana, São Paulo, 04014-002

    Recruiting

Other trials in Brazil

Spain9 sites, 9 recruiting

  • Hospital del Mar

    Barcelona

    Recruiting

  • Institut Catala di Oncologia - Hospital Duran i Reynals

    Barcelona

    Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid

    Recruiting

  • Hospital Universitario La Paz

    Madrid

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia

    Recruiting

  • Hospital Alvaro Cunqueiro

    Vigo

    Recruiting

Other trials in Spain

Australia7 sites, 7 recruiting

  • GenesisCare Research

    Campbelltown, Sydney, 2560

    Recruiting

  • Concord Repatriation General Hospital

    Concord, Sydney

    Recruiting

  • St. Vincent Hospital Melbourne

    Fitzroy, Melbourne, 3065

    Recruiting

  • Peninsula Health-Frankston hospital

    Frankston, Melbourne, 3940

    Recruiting

  • Central Coast Local Health District (Gosford and Wyong Hospital)

    Gosford, Sydney, 2250

    Recruiting

  • Macquarie University

    North Ryde, Sydney, 2109

    Recruiting

  • University of the Sunshine Coast Clinical Trials, Sunshine Coast Haematology and Oncology Clinic

    Sunshine Coast, Queensland, 4556

    Recruiting

Other trials in Australia

Germany7 sites, 7 recruiting

  • Klinikum St. Marien Amberg

    Amberg, 92224

    Recruiting

  • Evangelisches Krankenhaus Bielefeld gGmbH (EvKB)

    Bielefeld, 33611

    Recruiting

  • Universitaetsklinikum Carl-Gustav-Carus

    Dresden, 1307

    Recruiting

  • Hamatologisch-Onkologischen Praxis Eppendorf (HOPE)

    Hamburg, 20249

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Recruiting

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

    Recruiting

  • Kreiskliniken Reutlingen gGmbH

    Reutlingen, 72764

    Recruiting

Other trials in Germany

Italy7 sites, 7 recruiting

  • Azienda Ospedaliera San Sebastiano di Caserta

    Caserta, 81100

    Recruiting

  • ASST Cremona

    Cremona, 80131

    Recruiting

  • Universita degli Studi della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria

    Naples, 80131

    Recruiting

  • Gruppo Humanitas - Humanitas Research Hospital (Istituto Clinico Humanitas)

    Rozzano, 20089

    Recruiting

  • Instituto di Ricovero e Cura a Carattere Scientifico (IRCCS)

    San Giovanni Rotondo, 71013

    Recruiting

  • Azienda Ospedaliero Universitaria delle Marche

    Torrette, 60126

    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)

    Udine, 33100

    Recruiting

Other trials in Italy

Georgia5 sites, 5 recruiting

  • LLC Todua Clinic

    Tbilisi, 112

    Recruiting

  • Ltd "New Hospitals"

    Tbilisi, 114

    Recruiting

  • Tbilisi State Medical University and Ingorovka High Medical Technology University Clinic Ltd

    Tbilisi, 114

    Recruiting

  • JSV VIAN- Caraps Medline

    Tbilisi, 159

    Recruiting

  • Evex Hospitals - Caucasus Medical Center

    Tbilisi, 186

    Recruiting

Other trials in Georgia

Greece5 sites, 5 recruiting

  • Agios Savvas Cancer Hospital (Saint Savvas Regional Anticancer Oncology Hospital of Athens)

    Athens, 11522

    Recruiting

  • Medical Center, Psychiko Clinic

    Athens, 11527

    Recruiting

  • Sotiria General Hospital of Chest Diseases

    Athens, 11527

    Recruiting

  • Agioi Anargiroi General Oncology Hospital of Kifissia

    Kifissia, 14564

    Recruiting

  • Papageorgiou General Hospital

    Thessaloniki, 56429

    Recruiting

Other trials in Greece

Romania5 sites, 5 recruiting

  • Regional Institute of Gastroenterology and Hepatology

    Cluj-Napoca

    Recruiting

  • Clinica Amethyst Radiotherapy

    Craiova

    Recruiting

  • Centrul de Oncologie Sfantu Nectarie

    Floreşti

    Recruiting

  • Spitalul Pelican

    Oradea

    Recruiting

  • Sc Sigmedical Srl

    Suceava

    Recruiting

Other trials in Romania

Chile4 sites, 4 recruiting

  • Centro de Oncologia de Precision

    Santiago, Santiago Metropolitan, 7560908

    Recruiting

  • Instituto del Cancer RedSalud Vitacura

    Santiago, Santiago Metropolitan, 7630000

    Recruiting

  • Icegclinic

    Santiago, 8240000

    Recruiting

  • Fundacion Arturo Lopez Perez

    Santiago, 99010-080

    Recruiting

Other trials in Chile

Peru3 sites, 3 recruiting

  • Centro Especializado en Oncologia de Precision

    Lima

    Recruiting

  • Instiruto Nacional de Enfermedades Neoplasicas

    Lima

    Recruiting

  • Institutto Peruano de Oncologia y Radioterapia

    San Isidro

    Recruiting

Other trials in Peru

About this study

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

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).

Read the 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.

Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX22Drug

    HLX22 15mg/kg Q3w

  • PembrolizumabDrug

    Pembrolizumab 200mg q3w

  • TrastuzumabDrug

    Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W

  • OxaliplatinDrug

    Oxaliplatin 130 mg/m2 ,Q3W

  • CapecitabineDrug

    Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W

Study groups in NCT06532006
Study groupRoleWhat they receive
Experimental groupExperimentalExperimental 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)
Receives: Drug: HLX22; Drug: Trastuzumab; Drug: Oxaliplatin; Drug: Capecitabine
Control groupActive 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
Receives: Drug: Pembrolizumab; Drug: Trastuzumab; Drug: Oxaliplatin; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 5 years

  2. 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.

    Measured: Up to 5 years

Secondary outcomes (3)

  1. 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

    Measured: Up to 5 years

  2. 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.

    Measured: Up to 5 years

  3. 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.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start22 Nov 2024
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06532006
Sponsor's protocol ID
HLX22-GC-301
Status last verified
Dec 2025
First submitted
25 Jul 2024
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HLX22, Pembrolizumab and Trastuzumab in people with Gastroesophageal-junction Cancer and Monoclonal Antibody, run by Shanghai Henlius Biotech at 208 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 208 sites in China, United States, Japan, Argentina, Turkey (Türkiye) and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ying Li (+86 18810366427, ying_li1@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee) (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06532006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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