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NCT05836584 · ClinicalTrials.gov registry record · Phase 2
Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy in Locoregional MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer
A Phase 2 study of Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
- 20
- Study locations
NCT05836584 is a Phase 2 study of Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 240 participants, roughly in line with the 240-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target. The trial reports 20 study locations across 2 states.
The verdict
NCT05836584, a Phase 2 study of Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
- 20
- Study locations
Study 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 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
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Docetaxel
- DRUG Capecitabine
- BIOLOGICAL Atezolizumab
Study Locations (20)
California
- Kaiser Permanente Dublin - Dublin
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente-Fresno - Fresno
- Kaiser Permanente-Modesto - Modesto
- Kaiser Permanente-Oakland - Oakland
- Kaiser Permanente-Roseville - Roseville
- Kaiser Permanente Downtown Commons - Sacramento
- Kaiser Permanente-South Sacramento - Sacramento
- Kaiser Permanente-San Francisco - San Francisco
- Kaiser Permanente-Santa Teresa-San Jose - San Jose
- Kaiser Permanente San Leandro - San Leandro
- Kaiser San Rafael-Gallinas - San Rafael
- Kaiser Permanente Medical Center - Santa Clara - Santa Clara
- Kaiser Permanente-Santa Rosa - Santa Rosa
- Kaiser Permanente-South San Francisco - South San Francisco
- Kaiser Permanente-Vallejo - Vallejo
- Kaiser Permanente-Walnut Creek - Walnut Creek
Delaware
- Beebe South Coastal Health Campus - Millville
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2023-12-06 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05836584
The ClinicalTrials.gov registry entry for NCT05836584 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 240-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Gastric Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05836584 reports 20 study locations spanning 2 distinct geographic areas - top geographies include California, Delaware.
Frequently Asked Questions
What is clinical trial NCT05836584 about?
NCT05836584 is a clinical study titled "Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy in Locoregional 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...
What is the current status of trial NCT05836584?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2023-12-06. Estimated completion is 2027-10-31.
What conditions does trial NCT05836584 study?
This clinical trial studies the following conditions: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8.
What interventions are being tested in trial NCT05836584?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Docetaxel (DRUG), Capecitabine (DRUG), Atezolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05836584?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05836584 being conducted?
This trial has 20 study locations across California, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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