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Hope for stomach cancer: new combo trial aims to extend life

NCT ID NCT07270991

Disease control Sponsor: Federation Francophone de Cancerologie Digestive Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether adding fruquintinib to the standard drug trifluridine/tipiracil helps people with advanced stomach or gastro-esophageal cancer live longer. About 324 participants who have already tried at least two prior treatments will receive either the combo or trifluridine/tipiracil alone. The goal is to see if the combination improves overall survival.

What this could mean

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

Active substance
trifluridine/tipiracil and fruquintinib
What this could lead to
If successful, this combination could offer a new treatment option that extends life for patients with advanced stomach cancer who have run out of standard therapies.
What could go wrong
This is a Phase 3 trial, but the benefit may be modest (months, not years). Side effects from the drug combo could be significant, and the trial may not show a survival advantage.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 324 people

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

Started

Dec 2025

Expected to finish

Nov 2030

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. Age ≥ 18 years (patients enrolled gender independently). 2. Histologically proven metastatic adenocarcinoma of the stomach or the esophagogastric junction (GEJ) or esophagus. 3. Prior treatment by two or three lines of treatment for metastatic setting (patients who received adjuvant therapy and developed metastatic disease within 6 months of completing treatment should be considered as having failed first-line therapy for metastatic disease). 4. Prior treatment (progression or intolerance) with platinum salts (oxaliplatin or cisplatin), fluoropyrimidine and irinotecan and/or taxane (+/- anti-HER2 agents +/- immune checkpoint inhibitors +/- ramucirumab +/- anti-claudin 18.2). 5. Measurable or non-measurable lesions. (Response Evaluation Criteria in Solid Tumors (RECIST 1.1) 6. World Health Organisation (WHO) performance status 0-1. 7. Adequate organ function: ANC ≥ 1.5 x 109/L, hemoglobin ≥ 9 g/dL, platelets ≥ 100 G/L, AST/ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), total bilirubin ≤ 1.5 x ULN, creatinine clearance \> 30 mL/min (CKD EPI). 8. Adequate coagulation tests (INR and activated partial thromboplastin time (APTT) ≤1.5 × ULN) unless the patient is receiving anticoagulant therapy. 9. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. 10. Man and woman of childbearing potential agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception (use contraceptive methods that result in a failure rate of \<1% per year) during the study and for 6 months after the last treatment intake. 11. Patient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed. 12. Available tumor block (surgical specimens of primary tumor and if not available tumor biopsies). 13. Patient willing to participate to biological studies. Exclusion Criteria: 1. Concurrent enrolment in another clinical study - unless it is an observational study or during the follow-up for survival status update only of an interventional study. 2. Administration of the last dose of anticancer therapy and palliative radiotherapy ≤ 2 weeks prior to the first dose of study drug. 3. Current or prior bowel obstruction within 28 days before the first dose of study drugs. 4. Any unresolved clinical significant toxicity NCI CTCAE v5.0 ≥ grade 2 from previous anticancer therapy (except neuropathy). 5. More than 3 prior lines of treatment. 6. Major surgical procedure (e.g. exploratory laparoscopy is not considered as a major surgical procedure) within 2 weeks prior to the first dose of treatment. 7. History of leptomeningeal carcinomatosis or symptomatic or untreated brain metastase(s). Patients whose brain metastase(s) have been treated may participate if any neurologic symptoms that developed as a result of the brain metastases are resolved or stable. 8. Severe cardiac disorders (including but not limited to acute myocardial infarction, stroke, unstable angina, NYHA class III/IV heart failure, or LVEF\<50%) within 6 months. 9. Severe liver dysfunction (cirrhosis Child Pugh B or C). 10. Gastric or duodenal active ulcer. 11. Thromboembolic events (including deep vein thrombosis and pulmonary embolism) in the past 6 months 12. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled hypertension (defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg despite optimal medical management), interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, 13. psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. 14. Patients with urine protein test 2+ or more and 24 hours urine protein≥1.0g/24h. 15. Known positive test for HIV, active hepatitis B or hepatitis C, active tuberculosis. 16. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients (excipients with known effects and potential risk of allergies : tartrazine (E102) ,sunset yellow FCF (E110), Lactose monohydrate). 17. Prior treatment with trifluridine/tipiracil and/or fruquintinib and/or regorafenib and/or any anti-VEGFR tyrosine kinase inhibitor. 18. Active infection requiring intravenous antibiotics at the time of Day 1 of Cycle 1. 19. Other malignancy within 3 years prior to study enrolment, except for localized cancer in situ, basal or squamous cell skin cancer or other localized tumor with complete resection. 20. Treatment with powerful CYP 450 inducers (no contraindication for inhibitors). 21. Pregnant or breastfeeding female patient. 22. Congenital galactosemia, total lactase deficiency (lactose intolerance) or glucose-galactose malabsorption syndrome. 23. Patients with clinically significant bleeding within the past 2 months.

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Conditions

The condition(s) this trial relates to.

esophageal adenocarcinoma gastric adenocarcinoma gastroesophageal adenocarcinoma gastroesophageal junction adenocarcinoma neoplasm

As listed by the trial registrant

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

Metastatic oeso-gastric adenocarcinoma Metastatic oesogastric adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    64 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BORDEAUX-Institut Bergonié

    NOT_YET_RECRUITING

    Bordeaux, France

  • Bayonne- Clinique Belharra

    NOT_YET_RECRUITING

    Bayonne, France

  • C.H.U. de Brest

    NOT_YET_RECRUITING

    Brest, 29200, France

  • CAC - Paul Strauss

    NOT_YET_RECRUITING

    Strasbourg, France

  • CAC Antoine Lacassagne

    NOT_YET_RECRUITING

    Nice, France

  • CAC Jean Godinot

    NOT_YET_RECRUITING

    Reims, France

  • CAC Paoli Calmettes

    NOT_YET_RECRUITING

    Marseille, France

  • CHRU Nancy Brabois

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, France

  • CHRU de Tours - Hopital Trousseau

    NOT_YET_RECRUITING

    Tours, 37044, France

  • CHU - Charles Nicolle

    NOT_YET_RECRUITING

    Rouen, France

  • CHU Côte de Nacre

    NOT_YET_RECRUITING

    Caen, France

  • CHU Dupuytren

    NOT_YET_RECRUITING

    Limoges, France

  • CHU de Saint Etienne - Hôpital Nord

    NOT_YET_RECRUITING

    Saint-Priest-en-Jarez, 42270, France

  • Cac - François Baclesse

    NOT_YET_RECRUITING

    Caen, France

  • Center Hospitalier de Sens

    NOT_YET_RECRUITING

    Sens, 89108, France

  • Centre Eugène Marquis

    NOT_YET_RECRUITING

    Rennes, France

  • Centre Hospitalier

    NOT_YET_RECRUITING

    Aurillac, France

  • Centre Hospitalier

    NOT_YET_RECRUITING

    Bayeux, France

  • Centre Hospitalier

    NOT_YET_RECRUITING

    Cholet, France

  • Centre Hospitalier

    NOT_YET_RECRUITING

    Pau, 64046, France

  • Centre Hospitalier Côte Basque

    NOT_YET_RECRUITING

    Bayonne, France

  • Centre Hospitalier Emile Roux

    NOT_YET_RECRUITING

    Le Puy-en-Velay, France

  • Centre Hospitalier Lyon Sud

    NOT_YET_RECRUITING

    Pierre-Bénite, 69495, France

  • Centre Hospitalier Prive Saint Gregoire

    NOT_YET_RECRUITING

    Saint-Grégoire, France

  • Centre Hospitalier Saint Jean

    NOT_YET_RECRUITING

    Perpignan, France

  • Centre Leonard de Vinci

    NOT_YET_RECRUITING

    Dechy, France

  • Ch - Jean Rougier

    NOT_YET_RECRUITING

    Cahors, France

  • Ch Memorial France Etats Unis

    NOT_YET_RECRUITING

    Saint-Lô, France

  • Ch Nord Ouest

    NOT_YET_RECRUITING

    Villefranche-sur-Saône, France

  • Chu - Aphp - Hôpital Saint Louis

    NOT_YET_RECRUITING

    Paris, 75475, France

  • Chu - Centre Hospitalier Universitaire Robert Debre

    NOT_YET_RECRUITING

    Reims, 51092, France

  • Chu - Centre Hospitalier Universitaire de Poitiers - La Miletrie

    RECRUITING

    Poitiers, 86021, France

  • Chu - Hôpital Européen Georges Pompidou

    NOT_YET_RECRUITING

    Paris, France

  • Chu - Hôpital La Timone

    NOT_YET_RECRUITING

    Marseille, 13385, France

  • Clinique Mathilde

    NOT_YET_RECRUITING

    Rouen, France

  • Clinique Mutualiste de L'Estuaire

    NOT_YET_RECRUITING

    Saint-Nazaire, France

  • Clinique Sainte Anne

    NOT_YET_RECRUITING

    Strasbourg, France

  • Clinique Tivoli

    NOT_YET_RECRUITING

    Bordeaux, France

  • Clinique de Flandre

    NOT_YET_RECRUITING

    Coudekerque-Branche, France

  • Clinique de La Croix du Sud

    NOT_YET_RECRUITING

    Quint-Fonsegrives, France

  • Confluent Sas

    NOT_YET_RECRUITING

    Nantes, France

  • Gh Nord Essone

    NOT_YET_RECRUITING

    Orsay, France

  • Groupe Hospitalier Rance Emeraude

    NOT_YET_RECRUITING

    St-Malo, France

  • Groupement Hospitalier Bretagne Sud

    NOT_YET_RECRUITING

    Lorient, France

  • Haematologisch Onkologische Praxis Eppendorf

    NOT_YET_RECRUITING

    Hamburg, Germany

    Contact Email: •••••@•••••

  • Hia Begin

    NOT_YET_RECRUITING

    Saint-Mandé, France

  • Hia Sainte Anne

    NOT_YET_RECRUITING

    Toulon, France

  • Hôpital Cochin (APHP)

    NOT_YET_RECRUITING

    Paris, France

  • Hôpital FOCH

    NOT_YET_RECRUITING

    Suresnes, France

  • Hôpital Franco-Britannique

    NOT_YET_RECRUITING

    Levallois-Perret, France

  • Hôpital Prive Jean Mermoz

    NOT_YET_RECRUITING

    Lyon, 69008, France

  • ICONE

    NOT_YET_RECRUITING

    Bezannes, France

  • Institut Sainte Catherine

    NOT_YET_RECRUITING

    Avignon, 84000, France

  • Institut de cancérologie de Bourgogne GRReCC

    NOT_YET_RECRUITING

    Dijon, France

  • KEM/Evang. Kliniken Essen Mitte gGmbH

    NOT_YET_RECRUITING

    Essen, Germany

  • Klinikum Chemnitz gGmbH

    NOT_YET_RECRUITING

    Chemnitz, Germany

  • Klinikum Rechts Der Isar Der Technischen Universitat Munchen

    NOT_YET_RECRUITING

    München, Germany

  • Krankenhaus Nordwest GmbH

    NOT_YET_RECRUITING

    Frankfurt, Germany

  • Polyclinique

    NOT_YET_RECRUITING

    Rillieux-la-Pape, France

  • Privé - Groupe Hospitalier Diaconesses Croix Saint Simon

    NOT_YET_RECRUITING

    Paris, 75020, France

  • Rostock University Medical Center

    NOT_YET_RECRUITING

    Rostock, Germany

  • Saint Côme

    NOT_YET_RECRUITING

    Compiègne, France

  • Uniklinikum Leipzig

    NOT_YET_RECRUITING

    Leipzig, Germany

  • Universitätsklinikum Jena

    NOT_YET_RECRUITING

    Jena, Germany

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