In short
Clinical trials are studying HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 in people with locally advanced or metastatic gastroesophageal junction and gastric cancer. These studies mainly look at how well the treatment works and how long patients live, especially in first-line treatment.
Key points
- One clinical trial is studying HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 in people with locally advanced or metastatic gastroesophageal junction and gastric cancer. It is a Phase 3 study, so it is testing the treatment in a larger group of patients. The study looks at first-line treatment, meaning the first treatment used for this cancer. Researchers are comparing treatment combinations to see which works better. The main outcomes are progression-free survival and overall survival. The planned enrollment is 550 people.
Trial overview
The main study in the source data is NCT06532006, a randomized, double-blinded, multicenter, Phase 3 clinical study. It is testing HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 in people with locally advanced or metastatic gastroesophageal junction and gastric cancer.
This trial is authorised and plans to enroll 550 participants. The study is designed for first-line treatment, which means the first treatment given for this cancer.
Study design and treatment groups
This is an interventional study, meaning researchers assign the treatment rather than just observing what happens. The trial compares HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 plus trastuzumab and chemotherapy with trastuzumab and chemotherapy with or without pembrolizumab.
The chemotherapy backbone is XELOX, which is listed in the study title. The source also lists placebo versions for pembrolizumab and for HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2, showing that the study uses a blinded comparison.
- Randomized means people are assigned to groups by chance, which helps make the comparison fair.
- Double-blinded means the study is designed so that treatment assignment is hidden to reduce bias.
- Multicenter means the trial is run at more than one study site.
Who can participate
The trial is for patients with locally advanced or metastatic gastroesophageal junction and gastric cancer. These terms mean the cancer is either advanced near the original site or has spread to other parts of the body.
The study focuses on first-line treatment, so it is aimed at people starting treatment for this cancer rather than those who have already received several other treatments.
What the study measures
The primary outcomes are progression-free survival and overall survival. Progression-free survival means the time during and after treatment when the cancer does not get worse, while overall survival means how long patients live.
Progression-free survival is assessed by the Blinded Independent Central Review, using RECIST v1.1. RECIST v1.1 is a standard way to measure changes in tumors, such as whether they shrink, stay the same, or grow.
Why this trial matters
This study is important because it tests whether adding HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 to current treatment can improve outcomes for people with advanced stomach-related cancers. The Phase 3 design and larger enrollment suggest the researchers are looking for a clear answer about benefit in a real patient group.
The trial also compares treatment strategies that include or exclude pembrolizumab, which helps show whether the new study drug adds value on top of existing options. Because the study is first-line and includes a blinded comparison, it is built to give a strong test of the treatment approach.