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

RecruitingPhase 3Ages 18 Years - anyAllShanghai Henlius Biotech
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In plain words

What the trial is, and whether it could suit you

This is a double-blind, randomized, multiregion, comparative phase โ…ข 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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • HLX22
  • Pembrolizumab
  • Trastuzumab
  • Oxaliplatin
  • Capecitabine
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Where

208 sites
Los Angeles Cancer Network
Anaheim, United States
OPN - Oncology Physician Network (Los Alamitos)
Los Alamitos, United States
Banner MD Anderson Cancer Center
Greeley, United States
Advanced Research LLC
Deerfield Beach, United States
Florida Cancer Specialist - South
Fort Myers, United States
BRCR Medical Center
Plantation, United States
Napa Research
Pompano Beach, United States
Florida Cancer Specialist - North
St. Petersburg, United States

โ€ฆand 200 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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