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NCT06532006PHASE3Recruiting

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

Shanghai Henlius Biotech

Start Date

11/22/2024

Completion Date

9/1/2028

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).

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

HLX22

DRUG

Pembrolizumab

DRUG

Trastuzumab

DRUG

Oxaliplatin

DRUG

Capecitabine

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Conditions

Gastroesophageal-junction CancerMonoclonal AntibodyGastric CancerHER2-positive Gastric Cancer

Locations

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

Liuzhou,

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)