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Checkpoint Inhibitor
Atezolizumab + Chemotherapy for Stomach and Esophageal Cancer
Phase 2
Recruiting
Led By Lakshmi Rajdev
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial compares atezolizumab with chemo to treat gastric/GE junction cancers with MSI-H/dMMR. Atezolizumab helps body's immune system attack cancer and chemo drugs kill tumor cells.
Who is the study for?
Adults with untreated localized gastric or gastroesophageal junction adenocarcinoma that is MSI-H/dMMR, meaning their cancer cells have a high number of mutations. They must be fit for surgery, have not had prior curative surgery for this cancer type, and should not have received immune checkpoint inhibitors before. People with severe autoimmune diseases or those who recently received live vaccines are excluded.Check my eligibility
What is being tested?
The trial compares the effectiveness of atezolizumab (an immunotherapy drug) combined with chemotherapy to atezolizumab alone in controlling tumor growth in patients with certain types of stomach cancers. The study will assess if these treatments can shrink tumors before and after surgery without the disease worsening.See study design
What are the potential side effects?
Atezolizumab may cause immune-related reactions affecting organs, fatigue, infusion reactions similar to allergic responses, and increased risk of infections. Chemotherapy can lead to nausea, hair loss, blood cell count changes causing increased infection risk or bleeding problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free survival (EFS)
Secondary outcome measures
Circulating tumor-derived deoxyribonucleic acid (ctDNA)
Incidence of adverse events
Overall survival (OS)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (atezolizumab)Experimental Treatment8 Interventions
NEOADJUVANT THERAPY: Patients receive atezolizumab IV on study.
SURGERY: Patients undergo surgery with lymphadenectomy on study.
ADJUVANT THERAPY: Patients receive atezolizumab IV on study.
Patients also undergo CT or MRI throughout the trial. Patients may optionally undergo PET/CT and/or collection of blood samples throughout the trial. Patients may also undergo ECHO throughout the trial as clinically indicated.
Group II: Arm A (chemotherapy, atezolizumab)Experimental Treatment13 Interventions
NEOADJUVANT THERAPY: Patients receive physician's choice of chemotherapy regimen consisting of FLOT or mFOLFOX or CAPOX in addition to atezolizumab IV on study.
SURGERY: Patients undergo surgery with lymphadenectomy on study.
ADJUVANT THERAPY: Patients receive FLOT, mFOLFOX, or CAPOX and atezolizumab IV as in neoadjuvant therapy and then receive atezolizumab IV alone.
Patients also undergo CT or MRI throughout the trial. Patients may optionally undergo PET/CT and/or collection of blood samples throughout the trial. Patients may also undergo ECHO throughout the trial as clinically indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11540
Capecitabine
2013
Completed Phase 3
~3420
Atezolizumab
2017
Completed Phase 3
~5860
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Docetaxel
1995
Completed Phase 4
~5620
Echocardiography
2013
Completed Phase 4
~11670
Leucovorin Calcium
2011
Completed Phase 3
~12310
Lymphadenectomy
2021
Completed Phase 2
~1480
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Oxaliplatin
2011
Completed Phase 4
~2560
Positron Emission Tomography
2008
Completed Phase 2
~2240
Surgical Procedure
2020
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,671 Previous Clinical Trials
40,926,529 Total Patients Enrolled
Lakshmi RajdevPrincipal InvestigatorECOG-ACRIN Cancer Research Group
4 Previous Clinical Trials
453 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being enlisted for this clinical experiment?
"Affirmative. Information hosted on clinicaltrials.gov indicates that this medical experiment, which was first uploaded to the platform on June 8th 2024, is actively recruiting subjects. Approximately 240 patients need to be recruited from a single healthcare facility."
Answered by AI
Is the opportunity to participate in this research still available for those who qualify?
"As evinced by clinicaltrials.gov, this medical trial is actively recruiting patients and was initially posted on June 8th 2024 with the last update taking place on September 26th 2023."
Answered by AI
What potential risks might patients face with Arm A (chemotherapy, atezolizumab) treatment?
"Our analysts at Power have rated the safety of Arm A (chemotherapy, atezolizumab) as a 2 due to its status in Phase 2 trials. That is; there exists some evidence that it can be safe for patients but no data showing this treatment's efficacy."
Answered by AI
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