Clinical Stage I Gastric Cancer AJCC v8Phase 2NCT05836584
Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy in Locoregional MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer
A Phase 2 study testing Atezolizumab, Biospecimen Collection and Capecitabine in people with Clinical Stage I Gastric Cancer AJCC v8 and Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, run by National Cancer Institute (NCI) at 133 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage I Gastric Cancer AJCC v8, Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage II Gastric Cancer AJCC v8
- What is being tested?
- Atezolizumab, Biospecimen Collection and Capecitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 133 sitesUnited States
- Study dates
- 6 Dec 2023to 28 Jun 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be >= 18 years of age
- Patient must have histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma that is MSI-H/dMMR (microsatellite instability-high/mismatch repair deficient) as determined by one of three methods:
- Deficient deoxyribonucleic acid (DNA) mismatch repair protein (MMR) expression status: MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR. dMMR may be determined either locally or by site-selected reference lab by Clinical Laboratory Improvement Act (CLIA)-certified assay
- NOTE: Loss of MLH1 and PMS2 commonly occur together
- Polymerase chain reaction (PCR) determined microsatellite instability
- MSI-H tumor status determined by next-generation sequencing
Show all 48Show fewer
- Patient must have previously untreated localized gastric, or Siewert type II or III GEJ (gastroesophageal junction) adenocarcinoma. Tumors must be staged as T2 or greater primary lesion or be any T stage with the presence of positive locoregional lymph nodes- N+ (clinical nodes) without evidence of metastatic disease
- Siewert type II tumors: tumors located between 1 cm proximal and 2 cm distal to the GEJ
- Siewert type III tumors: tumors located between 2 and 5 cm distal to GEJ
- Patient must be amenable to surgical resection with therapeutic intent
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) >= 1,500/mcL (obtained =< 14 days prior to randomization)
- Platelets >= 100,000/mcL (obtained =< 14 days prior to randomization)
- Hemoglobin >= 9 g/dL (obtained =< 14 days prior to randomization)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) OR direct bilirubin =< ULN (for patients with total bilirubin > 1.5 x ULN) (obtained =< 14 days prior to randomization)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]): x =< 3 institutional ULN (obtained =< 14 days prior to randomization)
- Creatinine =< 1.5 x institutional ULN OR glomerular filtration rate (GFR) > 50 mL/min/1.73m^2 (obtained =< 14 days prior to randomization)
- Albumin >= 2.5 g/dL (obtained =< 14 days prior to randomization)
- International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN (unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time [PTT] is within therapeutic range of intended use of anticoagulants) (obtained =< 14 days prior to randomization)
- Activated partial thromboplastin time (aPTT) =< 1.5 x ULN (unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants) (obtained =< 14 days prior to randomization)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Patient must have no contraindications to receive one of the chemotherapy regimens: FLOT or mFOLFOX / CAPOX
- Patient must not have had prior potentially curative surgery for carcinoma of the stomach/GEJ
- Patient must not receive any other standard anti-cancer therapy or experimental agent concurrently with the study drugs
- Patient must have recovered from clinically significant adverse events of their most recent therapy/intervention prior to randomization
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Patient must have chest/abdomen/pelvis CT completed within 4 weeks prior to randomization
- Patient may not have received prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PDL-1, anti-PDL-2, anti-CTLA4 monoclonal antibody)
- Patient must not have received any live vaccines within 30 days prior to randomization and while participating in the study. Live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and coronavirus disease 2019 (COVID-19) (Note: intranasal influenza vaccines, such as Flu-Mist [registered trademark] are live attenuated vaccines and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events)
- Patient must not have active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain- Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis and hepatitis. Patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome are ineligible because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but otherwise are eligible.
- Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
- Patients must not be receiving systemic steroid therapy equivalent to > 10 mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to randomization. Topical corticosteroid or occasional inhaled corticosteroids are allowed
- Patient must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity, and must not have a known history of prior pneumonitis requiring treatment with steroids, or any evidence of active, non-infectious pneumonitis
- Patient must not have a known history of active TB (Bacillus Tuberculosis)
- Patient must not have any hypersensitivity to atezolizumab or any of its excipients
- Patient must not have received any prior chemotherapy, targeted small molecule therapy, or radiation therapy for their MSI-H/dMMR gastric and GEJ cancer
- Patient must not have had an allogeneic bone marrow/stem, cell or solid organ transplant
- Patient must not have a history or current evidence of any condition (e.g., known deficiency of the enzyme dihydropyrimidine dehydrogenase [DPD]), therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
- Patient must not have any condition that would interfere with the cooperation with the requirements of this trial
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
- All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy
- A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse while on protocol treatment. Patients of childbearing potential must continue contraception measures for 5 months after the last dose of atezolizumab and for 9 months after the last dose of chemotherapy. Male patients with partners of childbearing potential must continue contraception measures for 6 months after the last dose of chemotherapy. Patients of childbearing potential must also not breastfeed while on treatment and for 5 months after the last dose of atezolizumab and for 3 months after the last dose of chemotherapy
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- The investigator must declare the chemotherapy regimen their patient will receive (FLOT or mFOLFOX / CAPOX) prior to randomization
Who cannot join
None listed.
Trial locations and contacts
133 sites in 1 country.
133 sites in 1 country
United States133 sites
Mary Greeley Medical Center
Ames, Iowa, 50010
McFarland Clinic - Ames
Ames, Iowa, 50010
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Bronson Battle Creek
Battle Creek, Michigan, 49017
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
McFarland Clinic - Boone
Boone, Iowa, 50036
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Illinois CancerCare-Canton
Canton, Illinois, 61520
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Chelsea Hospital
Chelsea, Michigan, 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Mercy Hospital
Coon Rapids, Minnesota, 55433
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Northwest Cancer Center - Crown Point
Crown Point, Indiana, 46307
Carle at The Riverfront
Danville, Illinois, 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Kaiser Permanente Dublin
Dublin, California, 94568
Northwest Oncology LLC
Dyer, Indiana, 46311
Henry Ford River District Hospital
East China Township, Michigan, 48054
Fairview Southdale Hospital
Edina, Minnesota, 55435
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Kaiser Permanente-Fremont
Fremont, California, 94538
Kaiser Permanente-Fresno
Fresno, California, 93720
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, 48236
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236
Northwest Cancer Center - Hobart
Hobart, Indiana, 46342
Saint Mary Medical Center
Hobart, Indiana, 46342
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Saint Catherine Hospital
Indianapolis, Indiana, 46312
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, 48044
Henry Ford Warren Hospital - Breast Macomb
Macomb, Michigan, 48044
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Kaiser Permanente-Modesto
Modesto, California, 95356
The Community Hospital
Munster, Indiana, 46321
Women's Diagnostic Center - Munster
Munster, Indiana, 46321
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Mount Sinai West
New York, New York, 10019
Mount Sinai Hospital
New York, New York, 10029
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Providence Newberg Medical Center
Newberg, Oregon, 97132
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Kaiser Permanente-Oakland
Oakland, California, 94611
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Illinois CancerCare-Peru
Peru, Illinois, 61354
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Kaiser Permanente-Roseville
Roseville, California, 95661
Kaiser Permanente Downtown Commons
Sacramento, California, 95814
Kaiser Permanente-South Sacramento
Sacramento, California, 95823
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Kaiser Permanente-San Francisco
San Francisco, California, 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119
Kaiser Permanente San Leandro
San Leandro, California, 94577
Kaiser San Rafael-Gallinas
San Rafael, California, 94903
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403
Memorial Hospital East
Shiloh, Illinois, 62269
VCU Community Memorial Health Center
South Hill, Virginia, 23970
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Springfield Clinic
Springfield, Illinois, 62702
Springfield Memorial Hospital
Springfield, Illinois, 62781
Washington University School of Medicine
St Louis, Missouri, 63110
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764
Munson Medical Center
Traverse City, Michigan, 49684
Carle Cancer Center
Urbana, Illinois, 61801
Kaiser Permanente-Vallejo
Vallejo, California, 94589
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, 46383
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596
Henry Ford Health Warren Hospital
Warren, Michigan, 48093
Henry Ford Madison Heights Hospital - Breast
Warren, Michigan, 48093
Henry Ford Warren Hospital - GLCMS
Warren, Michigan, 48093
Illinois CancerCare - Washington
Washington, Illinois, 61571
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
University of Michigan Health - West
Wyoming, Michigan, 49519
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
About this study
Official title: A Randomized Phase II Study of Perioperative Atezolizumab +/- Chemotherapy in Resectable MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare three-year event-free survival (EFS) following the administration of perioperative atezolizumab and chemotherapy versus atezolizumab alone in patients with resectable microsatellite instability-high (MSI-H)/mismatch repair deficiency (dMMR) gastric and gastroesophageal junction (GEJ) cancer.
SECONDARY OBJECTIVES:
- To assess tumor regression grade (TRG) rates following the administration of perioperative atezolizumab and chemotherapy versus atezolizumab in patients with resectable MSI-H/dMMR gastric and gastroesophageal junction (GEJ) cancer.
II. To assess overall survival (OS) following the administration of perioperative atezolizumab and chemotherapy versus atezolizumab in patients with resectable MSI-H/dMMR gastric and gastroesophageal junction (GEJ) cancer.
III. To assess the toxicity associated with the administration of perioperative atezolizumab and chemotherapy versus atezolizumab in patients with resectable MSI-H/dMMR gastric and gastroesophageal junction (GEJ) cancer.
IV. To correlate circulating tumor-derived deoxyribonucleic acid (ctDNA) clearance (defined as > 50% reduction or a reduction to undetectable levels) with TRG, EFS and OS.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A:
NEOADJUVANT THERAPY: Patients receive physician's choice of chemotherapy regimen consisting of 4 cycles of docetaxel intravenously (IV), oxaliplatin IV, leucovorin calcium IV, and fluorouracil IV (FLOT) or 4 cycles of oxaliplatin IV, leucovorin calcium IV, and fluorouracil IV (mFOLFOX) or 3 cycles of oxaliplatin IV and capecitabine orally (PO) (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.
ARM B:
NEOADJUVANT THERAPY: Patients receive 3 cycles of atezolizumab IV on study.
SURGERY: Patients undergo surgery with lymphadenectomy on study.
ADJUVANT THERAPY: Patients receive 9 cycles of atezolizumab IV on study.
All patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) throughout the trial. Patients may optionally undergo positron emission tomography (PET)/CT and/or collection of blood samples throughout the trial. Patients may also undergo echocardiography (ECHO) throughout the trial as clinically indicated.
Patients are followed up for 10 years from the date of randomization.
- Conditions
- Clinical Stage I Gastric Cancer AJCC v8, Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage II Gastric Cancer AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Being tested
- Atezolizumab, Biospecimen Collection, Capecitabine, Computed Tomography, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabBiological
Also called MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A
Given IV
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood samples
CapecitabineDrug
Also called Ro 09-1978/000, Xeloda
Given PO
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT or PET/CT
DocetaxelDrug
Also called Docecad, RP 56976, RP-56976, RP56976
Given IV
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo ECHO
FluorouracilDrug
Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
Given IV
Also called Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate
Given IV
LymphadenectomyProcedure or surgery
Also called excision of the lymph node, Lymph Node Dissection, Lymph Node Excision
Undergo lymphadenectomy
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
OxaliplatinDrug
Also called 1-OHP, Ai Heng, Aiheng, Dacotin
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgery Type, Surgery, NOS
Undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm A (chemotherapy, atezolizumab) | Experimental | 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. Receives: Biological: Atezolizumab; Procedure: Biospecimen Collection; Drug: Capecitabine; Procedure: Computed Tomography; Drug: Docetaxel; Procedure: Echocardiography Test; Drug: Fluorouracil; Drug: Leucovorin Calcium; Procedure: Lymphadenectomy; Procedure: Magnetic Resonance Imaging; Drug: Oxaliplatin; Procedure: Positron Emission Tomography; Procedure: Surgical Procedure |
| Arm B (atezolizumab) | Experimental | 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. Receives: Biological: Atezolizumab; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Lymphadenectomy; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
EFS is defined as the time from randomization to an unfavorable event. Hence, occurrences such as local, resectable recurrences, patients' refusal for surgery of resectable tumor, or patients' undergoing definitive therapy such as salvage surgery would not be counted as events for EFS.
Measured: From randomization to systemic progression of disease that precludes surgery or distant recurrence, or death due to any cause, assessed up to 3 years
Secondary outcomes (4)
Tumor regression grade (TRG)
Will be assessed in the primary tumor using Becker's grading criteria. Fisher's exact test will be used to compare the TRG across the arms.
Measured: Up to 10 years
Overall survival (OS)
The stratified log rank test will be used to compare OS across the arms.
Measured: From randomization to death from any cause, assessed up to 10 years
Incidence of adverse events
All adverse events will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Formal comparison (hypothesis testing) of toxicity rates across the arms is not a primary goal of this trial and the sample size of 240 patients will provide sufficient power for detecting only relatively large differences in adverse events.
Measured: Up to 10 years
Circulating tumor-derived deoxyribonucleic acid (ctDNA)
The proportion of ctDNA clearance on each arm would be correlated with time-to-event (EFS and OS) and binary (TRG) data of the trial. For correlating ctDNA clearance rates and time-to-event data, cox-regression would be used to estimate the correlation magnitude. For correlating ctDNA and binary data, proportions of ctDNA clearances will be compared.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start6 Dec 2023
- Primary completion20 Jan 2026
- Study completion28 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage I Gastric Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lakshmi Rajdev, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836584
- Sponsor's protocol ID
- NCI-2023-03192
- Other IDs
- NCI-2023-03192, EA2212, EA2212, U10CA180820
- Status last verified
- Jun 2026
- First submitted
- 26 Apr 2023
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.