Adding New Treatments to Help Patients with Advanced Stomach and Esophageal Cancer

Recruiting · Phase 3 · Advanced Esophageal Adenocarcinoma and related conditions · 47 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This trial looks at two ways to treat advanced cancers of the esophagus, gastroesophageal junction, and stomach that cannot be surgically removed. It compares a combination of four medicines, called mFOLFIRINOX, to a different combination called mFOLFOX. The goal is to see which treatment helps patients live longer and feel better. Some patients may also receive an immunotherapy drug called nivolumab to help their immune system fight the cancer.

The trial's ID number is NCT05677490. This is a Phase 3 trial, which means it is looking at how well the treatments work and how safe they are. The study plans to include about 382 participants.

Who can join

This study is open to adults aged 18 and older, including both men and women. To join, participants must have a specific type of cancer that is HER2 negative and cannot be treated with surgery. They should not have had any prior treatment for their cancer that is now advanced. The trial team will check to confirm eligibility before enrollment.

Conditions

Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Metastatic Esophageal Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Unresectable Esophageal Adenocarcinoma, Unresectable Gastric Adenocarcinoma, Unresectable Gastroesophageal Junction Adenocarcinoma

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will be randomly assigned to one of two groups. In the first group, they will receive mFOLFIRINOX, which includes four medicines, plus nivolumab as needed. The second group will receive mFOLFOX, which includes three medicines, plus nivolumab as needed. All participants will have regular imaging tests like MRIs and CT scans, and some may provide blood samples during the study.