RECRUITING

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

Talk to us

Conditions

Gastroesophageal-junction CancerMonoclonal AntibodyGastric CancerHER2-positive Gastric Cancer

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2024-11-22
Study Completion:2028-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06532006

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male/female who are at least 18 years of age on the day of signing the informed consent.
  2. 2. With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
  3. 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. 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. 5. ECOG PS within 7 days before randomization: 0-1.
  6. 6. Expected survival ≥ 6 months.
  7. 7. Had adequate organ function
  1. 1. Patients with other malignant tumors within 2 years before the randomization.
  2. 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. 3. Previous treatment with any HER2-target therapy.
  4. 4. Active gastrointestinal bleeding
  5. 5. Presence of central nervous system (CNS) metastases.
  6. 6. Left ventricular ejection fraction (LVEF) \< 55%.
  7. 7. Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.

Contacts and Locations

Study Contact

Ying Li
CONTACT
+86 18810366427
ying_li1@henlius.com

Study Locations (Sites)

Los Angeles Cancer Network
Anaheim, California, 92801
United States
OPN - Oncology Physician Network (Los Alamitos)
Los Alamitos, California, 90720
United States
Access Research Institute
Brooksville, Florida, 34613
United States
Advanced Research LLC
Deerfield Beach, Florida, 33064
United States
BRCR Medical Center
Plantation, Florida, 33322
United States
Napa Research
Pompano Beach, Florida, 33064
United States
Washington University School of Medicine St. Louis
Saint 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
The University of Texas MD Anderson cancer Center
Houston, Texas, 77030
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

Collaborators and Investigators

Sponsor: Shanghai Henlius Biotech

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 Registration Dates

Study Start Date2024-11-22
Study Completion Date2028-09-01

Study Record Updates

Study Start Date2024-11-22
Study Completion Date2028-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Gastroesophageal-junction Cancer
  • Monoclonal Antibody
  • Gastric Cancer
  • HER2-positive Gastric Cancer