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Phase 2 Study of Chemotherapy and Immunotherapy for Advanced Esophageal and Gastric Adenocarcinoma

This study is testing new combinations of chemotherapy and immunotherapy drugs for people with advanced esophageal or gastric adenocarcinoma (cancers of the esophagus or stomach). Researchers want to see how safe and effective these combinations are as a first treatment. The study uses drugs like 5-FU, oxaliplatin, and nal-IRI (a chemotherapy drug), along with immunotherapy drugs such as trastuzumab (for HER2-positive cancers) and pembrolizumab. You could join if you are 18 or older, have advanced esophageal or gastric adenocarcinoma, and meet other health requirements. The main goals are to see how many people respond to the treatment and to track any side effects over about one year. The study is currently recruiting around 52 participants.

Study design
This is an open-label, Phase 2 study, meaning both you and your doctors will know which treatments you are receiving. It involves about 52 participants across multiple sites.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track your response to treatment and any side effects for up to one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04150640

Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Wisconsin, Madison
~52 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Nal-IRIOxaliplatin5-FUTrastuzumabPembrolizumabNivolumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort 1: Objective Response Rate (ORR)
Measured over up to 1 year
+2 more outcomes measured

Conditions

Esophageal Adenocarcinoma
Gastric Adenocarcinoma

Explore related trials

Esophageal AdenocarcinomaGastric AdenocarcinomaProgrammed Cell Death 1 Ligand 1

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Nataliya Uboha, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Cancer Connect
[email protected]
(800) 622-8922
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Written informed consent and HIPAA authorization for release of personal health information.
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
Absolute Neutrophil Count (ANC) ≥1,500 /μl without the use of hematopoietic growth factors
Hemoglobin (Hgb) ≥8 g/dL (blood transfusions are permitted for participants with hemoglobin levels below 8 g/dL)
Platelets ≥100,000 /μl
Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl). CrCl calculation using the Cockcroft-Gault formula. ≥50 mL/min for participants with creatinine levels \> 1.5 X institutional ULN
Bilirubin within normal range for the institution (biliary drainage is allowed for biliary obstruction); abnormal bilirubin (≤1·5 × upper limit of normal (ULN)) is allowed for patients with Gilbert's disease
Aspartate aminotransferase (AST) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
Alanine aminotransferase (ALT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Women of childbearing potential should have a negative urine or serum pregnancy test within 14 days of study registration. NOTE: Women are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
Women of childbearing potential and males must be willing to abstain from heterosexual activity or to use a form of effective method of contraception from the time of informed consent until 30 days after treatment discontinuation.
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Exclusion

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).
Participants must not have a condition requiring systemic treatment with either corticosteroids (\>10 mg/day prednisone equivalents) or other immunosuppressive medications within 14 days of study immunotherapy administration. Inhaled or topical steroids and adrenal replacement doses (≤10 mg/day prednisone equivalent) are permitted. Participants with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents.
Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.
Active infection requiring systemic therapy.
Pregnant or breastfeeding.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before inclusion.
NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure.
Known history of Human Immunodeficiency Virus (HIV).

What this trial measures

  • Cohort 1: Objective Response Rate (ORR)up to 1 year

    ORR will be calculated by combining the number of participants who achieve complete response and partial response per RECIST 1.1 criteria, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). An ORR of 40% or less for proposed combination of 5-Fluorouracil, Oxaliplatin and nal-IRI during 1st line treatment of advanced esophageal and gastric adenocarcinoma in HER2-negative subjects will be considered as unacceptably low. The number and frequencies of objectives responses will be summarized in tabular format. The ORR will be reported along with the corresponding one-sided 90% confidence intervals.

  • Cohort 3: Objective Response Rate (ORR)up to 1 year

    ORR will be calculated by combining the number of participants who achieve complete response and partial response per RECIST 1.1 criteria, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). An ORR of 45% or less for proposed combination of 5-Fluorouracil, Oxaliplatin, nal-IRI and Nivolumab during 1st line treatment of advanced esophageal and gastric adenocarcinoma in HER2-negative subjects will be considered as unacceptably low. The number and frequencies of objectives responses will be summarized in tabular format. The ORR will be reported along with the corresponding one-sided 90% confidence intervals.

  • Cohorts 2 and 4: Incidence of Adverse Eventsup to 1 year

    The primary objective of cohorts 2 and 4 (HER2-positive EGA) is to evaluate safety and tolerability of the studied drug combination. Toxicities and adverse events will be summarized by type and severity in tabular format.