A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
NCT ID: NCT06532006
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
550 participants
INTERVENTIONAL
2024-11-22
2028-09-01
Brief Summary
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Detailed Description
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In control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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)
HLX22
HLX22 15mg/kg Q3w
Trastuzumab
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
Oxaliplatin
Oxaliplatin 130 mg/m2 ,Q3W
Capecitabine
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W
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
Pembrolizumab
Pembrolizumab 200mg q3w
Trastuzumab
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
Oxaliplatin
Oxaliplatin 130 mg/m2 ,Q3W
Capecitabine
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W
Interventions
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HLX22
HLX22 15mg/kg Q3w
Pembrolizumab
Pembrolizumab 200mg q3w
Trastuzumab
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
Oxaliplatin
Oxaliplatin 130 mg/m2 ,Q3W
Capecitabine
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Henlius USA
UNKNOWN
Shanghai Henlius Biotech
INDUSTRY
Responsible Party
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Locations
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Los Angeles Cancer Network
Anaheim, California, United States
OPN - Oncology Physician Network (Los Alamitos)
Los Alamitos, California, United States
Banner MD Anderson Cancer Center
Greeley, Colorado, United States
Advanced Research LLC
Deerfield Beach, Florida, United States
Florida Cancer Specialist - South
Fort Myers, Florida, United States
BRCR Medical Center
Plantation, Florida, United States
Napa Research
Pompano Beach, Florida, United States
Florida Cancer Specialist - North
St. Petersburg, Florida, United States
Florida Cancer Specialist - East
West Palm Beach, Florida, United States
Northwestern University
Chicago, Illinois, United States
Mission Cancer + Blood (Exigent Network)
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center - University of Iowa
Iowa City, Iowa, United States
Washington University School of Medicine St. Louis
St Louis, Missouri, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Comprehensive Cancer Centers Nevada
Las Vegas, Nevada, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Guthrie Medical Group, PC and Robert Packer Hospital (Guthrie Cancer Center - Sayre)
Sayre, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Oncology - West (SCRI)
Abilene, Texas, United States
Texas Oncology Central South (SCRI)
Austin, Texas, United States
The University of Texas MD Anderson cancer Center
Houston, Texas, United States
Texas Oncology - Gulf Coast (SCRI)
Webster, Texas, United States
American Oncology Network Vista Oncology Division
Olympia, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, United States
St. Vincent Hospital Melbourne
Fitzroy, Melbourne, Australia
Peninsula Health-Frankston hospital
Frankston, Melbourne, Australia
University of the Sunshine Coast Clinical Trials, Sunshine Coast Haematology and Oncology Clinic
Sunshine Coast, Queensland, Australia
GenesisCare Research
Campbelltown, Sydney, Australia
Central Coast Local Health District (Gosford and Wyong Hospital)
Gosford, Sydney, Australia
Macquarie University
North Ryde, Sydney, Australia
Concord Repatriation General Hospital
Concord, , Australia
Centro de Oncologia de Precision
Santiago, Santiago Metropolitan, Chile
Instituto del Cancer RedSalud Vitacura
Santiago, Santiago Metropolitan, Chile
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Affiliated Hospital of Youjiang Medical University for Nationalities
Baise City, , 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
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
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
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
Nanjing Drum Tower Hospital
Nanjing, , China
The Affiliated Hospital of Qingdao University
Qingdao, , 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
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, , Georgia
Ltd "New Hospitals"
Tbilisi, , Georgia
Tbilisi State Medical University and Ingorovka High Medical Technology University Clinic Ltd
Tbilisi, , Georgia
JSV VIAN- Caraps Medline
Tbilisi, , Georgia
Evex Hospitals - Caucasus Medical Center
Tbilisi, , Georgia
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, , Japan
Ishikawa Prefectural Central Hospital
Kanazawa, , Japan
Osaki Citizen Hospital
Osaki-shi, , Japan
Saitama Cancer Center
Saitama, , Japan
Keiyukai Sapporo Hospital
Sapporo, , Japan
Countries
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Central Contacts
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Other Identifiers
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HLX22-GC-301
Identifier Type: -
Identifier Source: org_study_id
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