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

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID
NCT05177133
Phase
PHASE2
Status
Recruiting
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Conditions

  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    PO Capecitabine
  • Oxaliplatin — DRUG
    IV Oxaliplatin
  • Retifanlimab — DRUG
    IV retifanlimab

Study Details

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.

Key Dates

Start date
Nov 5, 2021
Status verified
Aug 2024
Primary completion
May 1, 2025
Completion
Nov 4, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Capecitabine, oxaliplatin and retifanlimab
    IV and PO Capecitabine 1000 mg/m2, oxaliplatin 130 mg/m2, every three weeks (up to 2 cycles) IV retifanlimab 500mg, every four weeks

Primary Outcome Measure

Effect of chemo- and immunotherapy on the interferon gamma expression signature in the tumor microenviornment [ Time Frame: 40 months ]

Central Contacts

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