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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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free survival (EFS)

Secondary study objectives

Circulating tumor-derived deoxyribonucleic acid (ctDNA)

Incidence of adverse events

Overall survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~11700

Capecitabine

2013

Completed Phase 3

~4280