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New chemo cocktail aims to fight esophageal cancer with fewer side effects

NCT ID NCT03764553

Disease control Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This phase 2 trial tests different chemotherapy combinations for people with advanced stomach or esophageal cancer that has spread or cannot be removed. The study compares a new liposomal form of irinotecan plus other drugs against standard treatments to see which works best at slowing cancer growth and causes less nerve damage. About 320 participants will be randomly assigned to one of three treatment groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Liposomal irinotecan, carboplatin, oxaliplatin, capecitabine, 5-fluorouracil, leucovorin
What this could lead to
If successful, this could identify a more effective and less nerve-damaging chemotherapy combination for advanced stomach or esophageal cancer.
What could go wrong
This is a mid-stage (phase 2) trial with 320 participants, so results are not definitive. The experimental combo may not improve survival or could cause unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must provide written informed consent according to International Conference on Harmonization (ICH)/Guideline for Good Clinical practice (GCP), and national/local regulations prior to any screening procedures. * Male or female adult patients (\> 18 years). * Patients with histologically confirmed diagnosis of metastatic or irresectable human epidermal growth (HER2) negative adenocarcinoma of the stomach or oesophagus; patients with HER2 positive disease are eligible when treatment with trastuzumab is contraindicated. If histology cannot be obtained, cytology is acceptable to prove metastatic disease. * Patients with metastatic or irresectable adenocarcinoma of the stomach or oesophagus not pre-treated with chemotherapy or radiotherapy for irresectable or metastatic disease. Palliative radiotherapy on the primary tumor or a metastatic lesion is allowed if other untreated lesions eligible for evaluation are present. * Measurable disease as assessed by RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) (WHO) performance status 0-2 * Patient has adequate bone marrow and organ function as defined by the following laboratory values: * Absolute Neutrophil Count (ANC) \> 1.5 x 109 /L * Hemoglobin (Hgb) \> 5.6 mmol/L * Platelets \> 100 x 109 /L * Serum total bilirubin within ≤ 1.5 x ULN (upper limit of normal); or total bilirubin \< 3.0 x upper limit of normal (ULN) with direct bilirubin within normal range in patients with well documented Gilbert's syndrome; biliary drainage is allowed for biliary obstruction * Serum creatinine \< 1.5 x ULN or creatinine clearance \>30 mL/min/1.73 m2 * Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) \< 2.5x ULN within normal range or \< 5.0 x ULN if liver metastases are present * If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test, beta-human chorionic gonadotropin (β-hCG) documented 72 hours prior to the first administration of study drug. If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug and after the end of treatment as recommended. * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. Exclusion Criteria: * Prior systemic treatment for metastatic or irresectable stomach or oesophageal cancer. * Evidence of disease progression within six months after completion of adjuvant or neoadjuvant treatment (whichever is last) containing a fluoropyrimidine and/or platinum compound and/or irinotecan; progression on neoadjuvant chemoradiation with carboplatin area under the curve (AUC2) and paclitaxel 50 mg/m2 within this time frame is allowed. * All target lesions in a radiation field without documented disease progression. 11 * Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart). * Past or current malignancy other than entry diagnosis interfering with prognosis of metastatic esophagogastric cancer. * Known uncontrollable hypersensitivity or contraindications to any of the components of liposomal irinotecan (Nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, leucovorin, oxaliplatin, carboplatin. Patients with previous dose reductions or delays are eligible. * Complete dihydropyrimidine dehydrogenase deficiency . * Patient has active, uncontrolled bacterial, viral or fungal infection(s) requiring systemic therapy. * Patient has known past or active infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C. * Signs of interstitial lung disease (ILD) * Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate patient participation in the clinical study. * Use of other investigational drugs within 30 days of enrollment. * Patient is enrolled in any other clinical protocol or investigational trial that will interfere with the primary endpoint. * Patients who in the investigators' opinion may be unwilling, unable or unlikely to comply with requirements of the study protocol. * Current use or any use in last two weeks of strong cytochrome P4503A (CYP3A-enzyme), CYP2C8, and/or strong UDP glucuronosyltransferase (UGT1A) inhibitors/inhibitors * Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use a reliable method of birth control, during therapy and for 3 months following the last dose of study treatment. * Treatment within 4 weeks with dihydropyrimidine dehydrogenase (DPD) inhibitors, including sorivudine or its chemically related analogues such as brivudine. * Pre-existing motor or sensory neurotoxicity greater than WHO grade 1.

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Conditions

The condition(s) this trial relates to.

esophageal cancer Esophageal Neoplasms gastroesophageal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal cancer

Contacts and locations

Locations

  • Academic Medical Center, Medical Oncology

    Amsterdam, 1100 DD, Netherlands

  • Admiraal de Ruijter Ziekenhuis

    Goes, 4460 AA, Netherlands

  • Amphia Ziekenhuis

    Breda, 4818 CK, Netherlands

  • Bravis ziekenhuis locatie Roosendaal

    Roosendaal, 4708 AE, Netherlands

  • Canisius Wilherlmina ziekenhuis

    Nijmegen, Netherlands

  • Catherina Ziekenhuis

    Eindhoven, Netherlands

  • Dijklander ziekenhuis

    Hoorn, Netherlands

  • Elkerliek ziekenhuis

    Helmond, Netherlands

  • Flevoziekenhuis

    Almere Stad, Netherlands

  • Haaglanden Medisch Centrum

    The Hague, Netherlands

  • Ikazia ziekenhuis

    Rotterdam, Netherlands

  • Isala Klinieken

    Zwolle, Netherlands

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ, Netherlands

  • Laurentius Ziekenhuis

    Roermond, Netherlands

  • Leids Universitair Medisch Centrum

    Leiden, Netherlands

  • Maasstadziekenhuis

    Rotterdam, Netherlands

  • Meander MC

    Amersfoort, Netherlands

  • Medisch Centrum Leeuwarden

    Leeuwarden, Netherlands

  • Nij Smellinghe

    Drachten, Netherlands

  • Radboud Universitair Medisch Centrum

    Nijmegen, Netherlands

  • Reinier de Graaf Gasthuis

    Delft, 2625 AD, Netherlands

  • Rijnstate Ziekenhuis

    Arnhem, 6815 AD, Netherlands

  • Rivierenland Ziekenhuis

    Rotterdam, Netherlands

  • Sint Antonius Ziekenhuis

    Nieuwegein, Netherlands

  • Sint Jansdal

    Harderwijk, Netherlands

  • Spaarne Gasthuis

    Hoofddorp, Netherlands

  • Tergooi ziekenhuizen

    Hilversum, Netherlands

  • Treant Zorggroep

    Emmen, Netherlands

  • Treant zorggroep

    Hoogeveen, 7909 AA, Netherlands

  • UMCU

    Utrecht, 3508 GA, Netherlands

  • VieCurie

    Roermond, 6043 CV, Netherlands

  • Ziekenhuis Gelderse Vallei

    Ede, Netherlands

  • Ziekenhuisgroep Twente

    Almelo, Netherlands

  • Zuyderland Medisch Centrum

    Geleen, Netherlands

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