Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy for Localized Gastric and Gastroesophageal Junction Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05836584

Provider View

This study is exploring whether using the immunotherapy drug atezolizumab alone or with chemotherapy can better control gastric and gastroesophageal junction cancer that hasn't spread far. The focus is on cancers with specific genetic features that might respond well to this treatment.

Patient Parameters

Program Overview

This phase II trial is comparing two treatment approaches for patients with gastric or gastroesophageal junction cancer that is localized or has only spread to nearby areas. The study focuses on cancers with high microsatellite instability (MSI-H) and mismatch repair deficiency (dMMR), which are specific genetic features. These features can make the cancer more likely to respond to immunotherapy. The trial is testing atezolizumab, an immunotherapy drug, both alone and in combination with chemotherapy drugs like docetaxel, oxaliplatin, leucovorin calcium, fluorouracil, and capecitabine. The goal is to see which approach is more effective in controlling the cancer and preventing it from coming back or getting worse.

Description

The main goal of this study is to compare the effectiveness of atezolizumab with and without chemotherapy in treating localized gastric and gastroesophageal junction cancer with specific genetic features (MSI-H/dMMR). Researchers want to see if these treatments can help patients live longer without the cancer returning or worsening.

Participants will be randomly assigned to one of two groups:

  • Group A: Patients will receive a combination of chemotherapy and atezolizumab before surgery. After surgery, they will continue with chemotherapy and atezolizumab, followed by atezolizumab alone.

  • Group B: Patients will receive atezolizumab alone before surgery. After surgery, they will continue with atezolizumab for a longer period.

Throughout the study, patients will undergo regular scans and tests to monitor their health and the cancer's response to treatment. The study will also look at how well the treatments are tolerated and any side effects that occur.

Participants will be followed for up to 10 years to track their long-term health and cancer outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of gastric or gastroesophageal junction cancer with MSI-H/dMMR genetic features.
  • Cancer must be localized or have only spread to nearby lymph nodes, and must not have been treated before.
  • Must be eligible for surgery to remove the cancer.
  • Have a good overall health status, with an ECOG performance score of 0-2.
  • Meet specific blood count and organ function requirements based on recent tests.
  • Must not have had prior surgery or treatment for this type of cancer.
  • Must not be receiving other cancer treatments during the study.
  • Women of childbearing potential must agree to use effective contraception during and after the study.
  • Must not have active autoimmune diseases or be on high-dose steroids.
  • Must not have received live vaccines recently.
  • Must not have a history of severe allergic reactions to atezolizumab or its components.
  • Must not be pregnant or breastfeeding.
  • Must be able to understand and sign a consent form.

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