RecruitingEsophageal AdenocarcinomaGastric Adenocarcinoma
Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: University of Wisconsin, Madison
You may qualify if…
- ✓ Written informed consent and HIPAA authorization for release of personal health information.
- ✓ NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- ✓ Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- ✓ Histological or cytological confirmed locally advanced or metastatic EGA. Known HER2 status prior to treatment initiation required. Known PDL1 CPS status prior to treatment initiation.
- ✓ Measurable disease according to RECIST v1.1.
- ✓ No prior lines of systemic therapy for advanced disease.
- ✓ Participants who had received neoadjuvant or adjuvant therapy or definitive chemoradiation will be allowed to participate if recurrence occurred 6 months or longer from the completion of all prior treatments.
- ✓ Demonstrate adequate organ function as defined below; all screening labs to be obtained within 14 days prior to registration
You may not qualify if…
- ✕ Known hypersensitivity to 5-FU, oxaliplatin or other platinum agents, or any of the components of nal-IRI and other liposomal products.
- ✕ Known dihydropyrimidine dehydrogenase (DPD) deficiency (testing not required prior to enrollment).
- ✕ Other active malignancy requiring treatment within the last 2 years. Exceptions include subjects with non-melanoma skin cancer, non-invasive/in situ cancer or low-risk prostate cancer requiring hormonal therapy only.
- ✕ Current therapy with other investigational agents or participation in another clinical study (supportive care and nontherapeutic trial participation allowed if not receiving an investigational drug). Participants may participate in prescreening for other therapeutic trials (prescreening of biologic sample for specific mutations, receptors, etc.)
- ✕ Major surgery within 28 days or minor surgery within 14 days of the start of the study treatment, except for tumor biopsy or placement of central infusion device (port placement).
- ✕ Radiotherapy less than 7 days prior to the start of the study treatment
- ✕ Participants who receive nivolumab or pembrolizumab in addition to chemotherapy should not have any contraindications to immune checkpoint inhibitors and should not have received immunotherapy agents for the treatment of EGA prior to study enrollment.
- ✕ Participants must not have active autoimmune disease that has required systemic treatment in the past 2 years. Participants are permitted to receive immunotherapy l 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).
Where it's recruiting
Wisconsin
Madison
Source: ClinicalTrials.gov · NCT04150640 · last updated 2026-06-23