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Clinical trialNCT05836584Active, not recruitingPhase 2Interventional

Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy in Locoregional MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer

SponsorNational Cancer Institute (NCI)Enrollment2Clinical Stage I Gastric Cancer AJCC v8Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage II Gastric Cancer AJCC v8Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage III Gastric Cancer AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8+4 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase II trial compares atezolizumab in combination with chemotherapy (docetaxel, oxaliplatin, leucovorin calcium, fluorouracil, capecitabine) to atezolizumab alone for controlling the growth and/or spreading of the disease in patients with gastric or gastroesophageal junction (JEG) cancer that has not spread from where it first started (local) or only has spread to nearby lymph nodes or tissue (locoregional) and has high microsatellite instability (MSI-H) and mismatch repair deficiency (dMMR). The mismatch repair (MMR) system in the body corrects errors made during the copying of DNA and serves as a proofreading function. If this system isn't working correctly, mutations (changes) in DNA occur which can allow the cancer to grow or spread. This is called dMMR (deficient mismatch repair) . MSI-H describes cancer cells that have a high number of mutations within microsatellites. For example, microsatellite testing that shows mutations in 30% or more microsatellites is called microsatellite instability-high (MSI-H). Microsatellites are short, repeated sequences of DNA. There is evidence that MSI-H/ dMMR gastric or GEJ tumors respond well to immunotherapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Chemotherapy drugs such as leucovorin calcium and fluorouracil work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Using atezolizumab as immunotherapy with and following chemotherapy versus atezolizumab alone prior to and after surgery may shrink or stabilize the tumor in patients with MSI-H/dMMR localized gastric or GEJ cancer and may increase the length of time after treatment that cancer does not come back or get worse.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

133 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Kaiser Permanente Dublin

    Dublin, California, United States

  • Kaiser Permanente-Fremont

    Fremont, California, United States

  • Kaiser Permanente-Fresno

    Fresno, California, United States

  • Kaiser Permanente-Modesto

    Modesto, California, United States

  • Kaiser Permanente-Oakland

    Oakland, California, United States

  • Kaiser Permanente-Roseville

    Roseville, California, United States

  • Kaiser Permanente Downtown Commons

    Sacramento, California, United States

  • Kaiser Permanente-South Sacramento

    Sacramento, California, United States

  • Kaiser Permanente-San Francisco

    San Francisco, California, United States

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California, United States

  • Kaiser Permanente San Leandro

    San Leandro, California, United States

  • Kaiser San Rafael-Gallinas

    San Rafael, California, United States

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, United States

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, United States

  • Kaiser Permanente-South San Francisco

    South San Francisco, California, United States

  • Kaiser Permanente-Vallejo

    Vallejo, California, United States

  • Kaiser Permanente-Walnut Creek

    Walnut Creek, California, United States

  • Beebe South Coastal Health Campus

    Millville, Delaware, United States

  • Helen F Graham Cancer Center

    Newark, Delaware, United States

  • Medical Oncology Hematology Consultants Pa

    Newark, Delaware, United States

  • Beebe Health Campus

    Rehoboth Beach, Delaware, United States

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, United States

  • Illinois Cancercare-Bloomington

    Bloomington, Illinois, United States

  • Illinois Cancercare-Canton

    Canton, Illinois, United States

  • Illinois Cancercare-Carthage

    Carthage, Illinois, United States

  • Carle at the Riverfront

    Danville, Illinois, United States

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, United States

  • Illinois Cancercare-Dixon

    Dixon, Illinois, United States

  • Carle Physician Group-Effingham

    Effingham, Illinois, United States

  • Crossroads Cancer Center

    Effingham, Illinois, United States

  • Illinois Cancercare-Eureka

    Eureka, Illinois, United States

  • Illinois Cancercare-Galesburg

    Galesburg, Illinois, United States

  • Illinois Cancercare-Kewanee Clinic

    Kewanee, Illinois, United States

  • Illinois Cancercare-Macomb

    Macomb, Illinois, United States

  • Carle Physician Group-Mattoon/charleston

    Mattoon, Illinois, United States

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, United States

  • Illinois Cancercare-Ottawa Clinic

    Ottawa, Illinois, United States

  • Illinois Cancercare-Pekin

    Pekin, Illinois, United States

  • Illinois Cancercare-Peoria

    Peoria, Illinois, United States

  • Illinois Cancercare-Peru

    Peru, Illinois, United States

93 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
6 Dec 2023
Primary completion
20 Jan 2026
Completion
28 Jun 2027
Last update posted
1 Jul 2026
Registered enrollment
2
Registry id
NCT05836584

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.