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Can a Triple-Drug attack slow down stomach cancer?

NCT ID NCT05476796

Disease control Sponsor: UNICANCER 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This phase 2 trial is testing whether a combination of trifluridine/tipiracil (Lonsurf) plus oxaliplatin, with or without the immunotherapy nivolumab, can help people with advanced HER2-negative stomach, esophageal, or gastroesophageal junction cancer. The study compares these combos to the standard FOLFOX regimen, also with or without nivolumab. Participants are frail patients whose cancer has spread or come back and who cannot have curative treatment. The main goal is to see if the new combinations extend the time patients live without their disease worsening.

What this could mean

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

Active substance
a combination of trifluridine/tipiracil (Lonsurf), oxaliplatin, and nivolumab (Opdivo)
What this could lead to
If successful, this could offer a new chemotherapy backbone option for frail patients with advanced gastric or esophageal cancer, potentially improving progression-free survival.
What could go wrong
This is a phase 2 trial with a relatively small number of participants (118), so results may not be definitive. Combining multiple drugs also raises the risk of side effects like neuropathy and immune-related reactions.

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 118 people

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

Started

Jun 2023

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: 1. Histologically confirmed locally advanced, recurrent or metastatic non resectable adenocarcinoma of the stomach, oesophagus or gastroesophageal junction (GEJ) ineligible to curative treatment. 2. No dysphagia or difficulty in swallowing. 3. No overexpression/amplification of HER2 (IHC 0 or 1+; if IHC is 2+, HIS must be negative). Known combined positive scor (CPS) PD-L1 score (result in % with the name of the method used). The microsatellite and mismatch repair (MMR) status of patient's tumour (MSI/MSS and pMMR/dMMR) must also be known at the time of screening (IHC and PCR tests have to be done). 4. At least one evaluable lesion according to RECIST v1.1 outside any previously irradiated area. 5. No prior palliative chemotherapy. 6. Age ≥18 years old. 7. Patient eligible for FOLFOX chemotherapy 8. Adequate organs function: * Absolute neutrophils count ≥1.5x10⁹/L * Platelets count ≥100x10⁹/L * Haemoglobin ≥9 g/L * Serum bilirubin levels \<2 times upper limit of normal (ULN), up to 2.5 times ULN in case of hepatic metastasis (biliary drainage allowed) * Transaminases \<5 times ULN * Creatinine clearance \>40 mL/min 9. No Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia \<16 ng/ml) 10. Women of childbearing potential must have a negative serum or urine pregnancy test done within 14 days before the first study treatment. 11. Patients must agree to use adequate contraception methods for the duration of study treatment and within 6 months after completing treatment. 12. Patients must be affiliated to a Social Security System (or equivalent). 13. Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent. 14. Availability of archived tumour material for ancillary studies Exclusion Criteria: 1. Patient with a performance status ECOG PS \>2. 2. Other current or previous malignancy within the past 3 years (with the exception of squamous cell carcinoma of the skin treated by surgery). 3. Adjuvant chemotherapy or radio-chemotherapy completed for less than 6 months. 4. Peripheral neuropathy of NCI-CTCAE grade ≥2 at baseline. 5. Patients with known allergy or severe hypersensitivity to any of the trial drugs or any of the trial drug excipients. 6. Patients unwilling or unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial. 7. Previous treatment with trifluridine/tipiracil. 8. Known Human Immunodeficiency Virus (HIV) infection. 9. Active Hepatitis B virus (HBV, defined as having a positive hepatitis B surface antigen \[HBsAg\] test prior to inclusion) or hepatitis C virus (HCV). 10. Interstitial lung disease. 11. Prior pneumonitis requiring systemic corticosteroid therapy. 12. Active infections. 13. Pregnant or breastfeeding woman. 14. Participation in another therapeutic trial within the 30 days prior to randomisation. 15. Persons deprived of their liberty or under protective custody or guardianship. 16. Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia (for men: QTc ≥450 msec, for women: QTc ≥470 msec) 17. Active systemic autoimmune disease. Subjects with 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 are permitted to enrol. 18. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first study drug administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease

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Conditions

The condition(s) this trial relates to.

adenocarcinoma Adenocarcinoma Of Esophagus esophageal adenocarcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma Neoplasm Metastasis Recurrence

As listed by the trial registrant

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

Esophagus adenocarcinoma Gastric adenocarcinoma Gastroesophageal junction adenocarcinoma

Contacts and locations

Locations

  • CH Cholet

    Cholet, 49000, France

  • CHU - Hôpital Robert Debré

    Reims, 51092, France

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030, France

  • CHU Morvan

    Brest, 29200, France

  • CHU Nancy - Hôpital Brabois

    Vandœuvre-lès-Nancy, 54500, France

  • CHU Rouen - Charles Nicolle

    Rouen, 76000, France

  • CHU d'Estaing

    Clermont-Ferrand, 63100, France

  • CHU de Poitiers

    Poitiers, 86000, France

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Hospitalier de Beauvais

    Beauvais, 60021, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Léon Bérard

    Lyon, 69373, France

  • Clinique Pasteur Lanroze

    Brest, 29200, France

  • Clinique de l'Europe

    Amiens, 80000, France

  • GH Diaconesses - Crois St Simon

    Paris, 75020, France

  • Hopital Europeen Georges Pompidou

    Paris, 75015, France

  • Hopital Privé Arras Les Bonnettes

    Arras, 62000, France

  • Hôpital Nord Franche Comté

    Montbéliard, 25250, France

  • Hôpital Nord-Ouest Villefranche-sur-Saône

    Gleizé, 69400, France

  • Hôpital Saint Joseph

    Marseille, 13008, France

  • Hôpital Saint Louis

    Paris, 75010, France

  • ICO - Site René Gauducheau

    Saint-Herblain, 44805, France

  • Institut Andrée Dutreix - Clinique de Flandre

    Coudekerque-Branche, 59210, France

  • Institut Jean Godinot

    Reims, 51100, France

  • Institut Mutualiste Montsouris

    Paris, 75674, France

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Institut Sainte Catherine

    Avignon, 84000, France

  • Institut de cancérologie Strasbourg Europe

    Strasbourg, 67033, France

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