Study on Safety and Effectiveness of Treatment Combinations With and Without Chemotherapy for Advanced Upper Gastrointestinal Cancers
Sponsor: Arcus Biosciences, Inc.
ClinicalTrials ID:NCT05329766
This clinical trial is testing different treatment combinations, some with chemotherapy and some without, to see how safe and effective they are for adults with advanced stomach, gastroesophageal junction, or esophageal cancers that cannot be removed by surgery or have spread to other parts of the body.
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Program Overview
The aim of this study is to assess the safety and initial effectiveness of various treatment combinations, including some that use chemotherapy, for patients with advanced cancers of the stomach, gastroesophageal junction (GEJ), and esophagus. The chemotherapy used in this study includes a combination of drugs known as FOLFOX, which consists of oxaliplatin, leucovorin, and fluorouracil.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced stomach, GEJ, or esophageal cancer that cannot be surgically removed or has spread.
- Have a life expectancy of at least 3 months, as determined by the study doctor.
- Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have at least one tumor that can be measured using standard criteria.
- Have good organ and bone marrow function.
- Be able to provide a previous tumor sample for testing.
Exclusion Criteria
- Have medical conditions that could make the study treatments unsafe, according to the study doctor or sponsor.
- For one group of participants, have a tumor that is known to be HER-2 positive.
- Have untreated, symptomatic, or worsening cancer that has spread to the brain. Participants with cancer spread to the membranes around the brain are also excluded.
- Have stopped previous immune therapy due to side effects or have been treated with an anti-TIGIT antibody.
- Have had a major injury or surgery within 28 days before joining the study.
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