Phase 3 Study of HLX22 with Trastuzumab and Chemotherapy for Treating Gastroesophageal Junction and Gastric Cancer
Sponsor: Shanghai Henlius Biotech
ClinicalTrials ID:NCT06532006
This clinical trial is testing a new combination of drugs, including HLX22, trastuzumab, and chemotherapy, to see if it is effective and safe as a first treatment for patients with advanced HER2-positive gastric or gastroesophageal junction cancer.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to find out if adding HLX22 to trastuzumab and chemotherapy can help treat patients with HER2-positive gastric or gastroesophageal junction cancer that is advanced or has spread. Participants will be randomly assigned to receive either the new combination treatment or a standard treatment, and will continue until the treatment no longer benefits them, they experience severe side effects, or they choose to stop.
Description
Participants in the experimental group will receive HLX22 along with trastuzumab and chemotherapy (XELOX), with or without a placebo for pembrolizumab, every three weeks. Those in the control group will receive a placebo instead of HLX22, along with trastuzumab and chemotherapy (XELOX), with or without pembrolizumab, every three weeks.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Diagnosed with advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer that has not been treated before.
- Have at least one tumor that can be measured by scans, and it should not be only in the bones.
- Tumor must be HER2-positive, confirmed by specific lab tests.
- Be in good general health with an ECOG performance status of 0 or 1.
- Expected to live at least 6 more months.
- Have good organ function.
Exclusion Criteria
- Have had another type of cancer within the last 2 years.
- Cancer has worsened within 6 months after previous chemotherapy or radiotherapy for gastric or gastroesophageal cancer.
- Have received any previous HER2-targeted therapy.
- Have active bleeding in the digestive tract.
- Have cancer that has spread to the brain or spinal cord.
- Have a heart function below 55%.
- Have a history of severe allergic reactions to monoclonal antibodies or any part of the study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Los Angeles Cancer Network | 92801 | Anaheim | California |
| OPN - Oncology Physician Network (Los Alamitos) | 90720 | Los Alamitos | California |
| Banner MD Anderson Cancer Center | 80631 | Greeley | Colorado |
| Advanced Research LLC | 33064 | Deerfield Beach | Florida |
| Florida Cancer Specialist - South | 33901 | Fort Myers | Florida |
| BRCR Medical Center | 33322 | Plantation | Florida |
| Napa Research | 33064 | Pompano Beach | Florida |
| Florida Cancer Specialist - North | 33705 | St. Petersburg | Florida |
| Florida Cancer Specialist - East | 33401 | West Palm Beach | Florida |
| Northwestern University | 60611 | Chicago | Illinois |
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