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

NCT04150640 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-02-24

No results posted yet for this study

Summary

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

  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma

Interventions

DRUG

Nal-IRI

chemotherapy drug

DRUG

Oxaliplatin

chemotherapy drug

DRUG

5-FU

chemotherapy drug

DRUG

Trastuzumab

immunotherapy

DRUG

Pembrolizumab

immunotherapy

DRUG

Nivolumab

immunotherapy

Sponsors & Collaborators

  • Ipsen

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04150640 on ClinicalTrials.gov