Combination Chemotherapy for Stomach and Esophageal Cancer

This trial tests a new drug combination for treating stomach and esophageal cancer, specifically adenocarcinoma. The researchers aim to determine if this treatment is gentler on the body than current options. The trial includes different groups based on whether the cancer is HER2-positive or HER2-negative, a specific protein marker. Individuals with advanced esophageal or gastric adenocarcinoma who have not received prior systemic therapy may be suitable for this study. The combination includes Nal-IRI (also known as Onivyde or Liposomal Irinotecan), Oxaliplatin, and Trastuzumab (also known as Herceptin). As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

The trial information does not specify if you need to stop taking your current medications. However, you cannot be on other investigational drugs or have certain conditions that require systemic treatment with corticosteroids or immunosuppressive medications within 14 days of starting the trial.

Research has shown that the treatments in this trial have varying safety levels based on earlier studies. Each treatment is detailed below:

For nal-IRI (a form of irinotecan), studies have found that some patients experience serious side effects. About 44% of patients reported severe reactions, primarily a low white blood cell count and diarrhea.

Oxaliplatin is effective but can cause side effects like nausea and nerve damage, leading to tingling in the hands and feet. These side effects are generally well-understood and managed.

Trastuzumab, used for HER2-positive cancers, has been extensively studied. Some patients experience heart-related issues, but overall, it is considered safe for many when monitored properly.

Researchers are excited about these treatments for stomach and esophageal cancer because they introduce innovative drug combinations that target cancer in new ways. Unlike current standard treatments that often rely on traditional chemotherapy alone, such as FOLFOX or EOX regimens, these investigational therapies incorporate targeted and immune-modulating agents like trastuzumab, pembrolizumab, and nivolumab. Trastuzumab specifically targets the HER2 protein, which is overexpressed in some cancers, while pembrolizumab and nivolumab enhance the immune system's ability to fight cancer cells. These combinations may potentially offer more effective treatment options, particularly for patients with HER2-positive cancers, and could improve outcomes by leveraging the body's immune response alongside chemotherapy.

Research shows that the combination of drugs in this trial may help treat stomach and esophageal cancers. Participants in different cohorts will receive specific drug combinations. Studies have found that nal-IRI, a type of irinotecan, improves survival rates when combined with other chemotherapy drugs. Oxaliplatin, another chemotherapy drug, effectively treats advanced stomach cancers, showing a good response rate. Trastuzumab, used for HER2-positive tumors, has proven to extend patients' lives with these cancers. These findings suggest that the drug combinations in this study might effectively treat esophageal and stomach adenocarcinoma.³⁶⁷⁸⁹