RecruitingPhase 2NCT05177133

Anti-PD-1 and CapOx for the First-line Treatment of dMMR Esophagogastric Cancer (AuspiCiOus)

Anti-PD-1, Capecitabine, and Oxaliplatin for the First-line Treatment of dMMR Esophagogastric Cancer (AuspiCiOus-dMMR): a Proof-of-principle Study


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

25 participants

Start Date

Nov 5, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

To investigate the effects of the combination of two chemotherapies followed by immunostimulants on the interferon gamma expression and infiltration of cytotoxic T cells in the tumour microenvironment in patients with previously untreated metastatic or locally advanced esophagogastric cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (an anti-PD-1 agent) to standard chemotherapy (capecitabine and oxaliplatin) improves outcomes as a first-line treatment for patients with a specific type of advanced stomach or esophageal cancer that has a genetic marker called dMMR (mismatch repair deficiency), which means the cancer's repair system is faulty. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with advanced or inoperable HER2-negative adenocarcinoma of the stomach or the area where the esophagus meets the stomach - Your tumor has been tested and found to be dMMR-positive - You have not yet received chemotherapy or radiation for advanced or metastatic disease - You are in reasonably good health (ECOG 0–2) - Your blood counts, liver, and kidney function are in acceptable range - Your tumor is accessible for biopsy **You may NOT be eligible if:** - Your tumor is HER2-positive (unless trastuzumab is not an option for you) - You have already received chemotherapy for metastatic disease - You have serious heart, liver, or blood problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

PO Capecitabine

DRUGOxaliplatin

IV Oxaliplatin

DRUGRetifanlimab

IV retifanlimab


Locations(8)

Academic Medical Center, Medical Oncology

Amsterdam, Netherlands

Amsterdam UMC, location VUmc

Amsterdam, Netherlands

Catharina ziekenhuis

Eindhoven, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

LUMC

Leiden, Netherlands

Radboud UMC

Nijmegen, Netherlands

Erasmus MC

Rotterdam, Netherlands

UMC Utrecht

Utrecht, Netherlands

View Full Details on ClinicalTrials.gov

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NCT05177133


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