Actively Recruiting
Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma
Led by University of Wisconsin, Madison · Updated on 2026-02-24
52
Participants Needed
1
Research Sites
385 weeks
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
I
Ipsen
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and Gastric Adenocarcinoma (EGA). The investigators hypothesize that this drug combination will be better tolerated than current first-line chemotherapy combinations for this disease.
CONDITIONS
Official Title
Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization for personal health information release
- Have an ECOG Performance Status of 0 to 2
- Have confirmed locally advanced or metastatic esophageal or gastric adenocarcinoma with known HER2 and PDL1 CPS status
- Have measurable disease based on RECIST v1.1 criteria
- Have not received prior systemic therapy for advanced disease
- Prior neoadjuvant, adjuvant therapy, or definitive chemoradiation allowed if recurrence occurred 6 months or more after treatment completion
- Meet specific organ function requirements including ANC ≥1500/µL, hemoglobin ≥8 g/dL, platelets ≥100,000/µL, creatinine clearance ≥50 mL/min, normal bilirubin, AST and ALT within specified limits, and acceptable coagulation parameters
- Women of childbearing potential must have a negative pregnancy test within 14 days prior to registration
- Women of childbearing potential and males must agree to use effective contraception or abstain from heterosexual activity during the study and for 30 days after treatment ends
- Be able to understand and comply with study procedures as judged by the enrolling physician
You will not qualify if you...
- Known allergy to 5-FU, oxaliplatin, nal-IRI, or liposomal products
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Other active cancer requiring treatment within the past 2 years, except certain skin or prostate cancers
- Currently receiving other investigational treatments or enrolled in another clinical trial with investigational drugs
- Major surgery within 28 days or minor surgery within 14 days before study treatment, except biopsy or port placement
- Radiotherapy less than 7 days before starting study treatment
- Contraindications to immune checkpoint inhibitors if receiving nivolumab or pembrolizumab, including active autoimmune disease requiring recent systemic treatment or immunosuppressive medications
- History of immune-related adverse events leading to permanent immunotherapy discontinuation
- Psychological, social, or familial conditions that could interfere with study compliance
- Active infection requiring systemic therapy
- Pregnancy or breastfeeding
- Known active brain metastases or carcinomatous meningitis (stable treated brain metastases allowed)
- Severe recent arterial thromboembolic events within 6 months
- Severe heart failure, ventricular arrhythmias, or uncontrolled blood pressure
- Known HIV infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
C
Cancer Connect
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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