Metastatic Oesogastric AdenocarcinomaPhase 3FRUQUITASNCT07270991
Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma
A Phase 3 study testing trifluridine/tipiracil and fruquintinib in people with Metastatic Oesogastric Adenocarcinoma, run by Federation Francophone de Cancerologie Digestive at 64 sites in 2 countries.
Trial summary
Advanced cancer of the stomach and the gastro-esophageal junction (G/GEJ) remains a very serious disease. Today, only about 10-15% of patients are alive after 5 years. Treatments mainly aim to control symptoms, extend life, and maintain quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Oesogastric Adenocarcinoma
- What is being tested?
- trifluridine/tipiracil and fruquintinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 64 sitesin 2 countries
- Study dates
- 15 Dec 2025to 30 Nov 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years (patients enrolled gender independently).
- Histologically proven metastatic adenocarcinoma of the stomach or the esophagogastric junction (GEJ) or esophagus.
- 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).
- 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).
- Measurable or non-measurable lesions. (Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- World Health Organisation (WHO) performance status 0-1.
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- 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).
- Adequate coagulation tests (INR and activated partial thromboplastin time (APTT) ≤1.5 × ULN) unless the patient is receiving anticoagulant therapy.
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
- 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.
- Patient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed.
- Available tumor block (surgical specimens of primary tumor and if not available tumor biopsies).
- Patient willing to participate to biological studies.
Who cannot join
- 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.
- Administration of the last dose of anticancer therapy and palliative radiotherapy ≤ 2 weeks prior to the first dose of study drug.
- Current or prior bowel obstruction within 28 days before the first dose of study drugs.
- Any unresolved clinical significant toxicity NCI CTCAE v5.0 ≥ grade 2 from previous anticancer therapy (except neuropathy).
- More than 3 prior lines of treatment.
- 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.
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- 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.
- 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.
- Severe liver dysfunction (cirrhosis Child Pugh B or C).
- Gastric or duodenal active ulcer.
- Thromboembolic events (including deep vein thrombosis and pulmonary embolism) in the past 6 months
- 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,
- 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.
- Patients with urine protein test 2+ or more and 24 hours urine protein≥1.0g/24h.
- Known positive test for HIV, active hepatitis B or hepatitis C, active tuberculosis.
- 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).
- Prior treatment with trifluridine/tipiracil and/or fruquintinib and/or regorafenib and/or any anti-VEGFR tyrosine kinase inhibitor.
- Active infection requiring intravenous antibiotics at the time of Day 1 of Cycle 1.
- 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.
- Treatment with powerful CYP 450 inducers (no contraindication for inhibitors).
- Pregnant or breastfeeding female patient.
- Congenital galactosemia, total lactase deficiency (lactose intolerance) or glucose-galactose malabsorption syndrome.
- Patients with clinically significant bleeding within the past 2 months.
Trial locations and contacts
64 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
64 sites in 2 countries
France56 sites, 56 recruiting
- Not yet recruiting
Centre Hospitalier
Aurillac
DANIELA BURLACU, 04 71 46 47 41, d.burlacu@ch-aurillac.fr
Daniela BERLACU
- Not yet recruiting
Institut Sainte Catherine
Avignon, 84000
May MABRO, MD, 0490276268, m.mabro@isc84.org
May MABRO
- Not yet recruiting
Centre Hospitalier
Bayeux
ANNIE PEYTIER, 02 31 51 54 17, a.peytier@ch-ab.fr
Annie PEYTIER
- Not yet recruiting
Bayonne- Clinique Belharra
Bayonne
Marjorie FAURE, +335 36 28 90 02, marjorie.faure@copb.eu
Marjorie FAURE
- Not yet recruiting
Centre Hospitalier Côte Basque
Bayonne
Franck AUDEMAR, 05 59 44 33 62, faudemar@ch-cotebasque.fr
FRANCK AUDEMAR
- Not yet recruiting
ICONE
Bezannes
William MINA, 03 26 24 40 00, wmina@icone.fr
WILLIAM MINA
- Not yet recruiting
BORDEAUX-Institut Bergonié
Bordeaux
Lola Jade PALMIERI, 05 56 33 32 78, l.palmieri@bordeaux.unicancer.fr
Lola Jade PALMIERI
- Not yet recruiting
Clinique Tivoli
Bordeaux
VALERIE COCHIN, 05 56 69 06 71, v.cochin@tivoli-oncologie.fr
Valérie COCHIN
- Not yet recruiting
C.H.U. de Brest
Brest, 29200
Jean-Philippe Metges, MD, 33-2-9822-3333, jean-philippe.metges@chu-brest.fr
Jean-Philippe Metges
- Not yet recruiting
Cac - François Baclesse
Caen
Mélanie DOS SANTOS, 02 31 45 50 02, m.dossantos@baclesse.unicancer.fr
Mélanie DOS SANTOS
- Not yet recruiting
CHU Côte de Nacre
Caen
Anne-Laure BIGNON-BRETAGNE, 0231065437, bignon-al@chu-caen.fr
Anne-Laure BIGNON-BRETAGNE
- Not yet recruiting
Ch - Jean Rougier
Cahors
Maher NASRI, 05.65.20.50.21, maher.nasri@ght-lot.fr
Maher NASRI
- Not yet recruiting
Centre Hospitalier
Cholet
Thomas DAVIEAU, 0241498491, thomas.davieau@ch-cholet.fr
Thomas DAVIEAU
- Not yet recruiting
Saint Côme
Compiègne
Kaïs ALDABBAGH, MD, kais.aldabbagh@stcome.com
Kaïs ALDABBAGH
- Not yet recruiting
Clinique de Flandre
Coudekerque-Branche
Jean Baptiste AISENFARB, MD, jbaisenfarb@iadonco.org
Jean-Baptiste AISENFARB
- Not yet recruiting
Centre Leonard de Vinci
Dechy
NATACHA STERN-LEDIEU, 03 20 29 59 59, nstern@clinique-psv.fr
NATACHA STERN-LEDIEU
- Not yet recruiting
Institut de cancérologie de Bourgogne GRReCC
Dijon
Antoine DROUILLARD, 03 80 67 30 10, adrouillard@icb-cancer.fr
Antoine DROUILLARD
- Not yet recruiting
Centre Hospitalier Emile Roux
Le Puy-en-Velay
Kheir Eddine BENMAMMAR, 04 71 04 33 36, kheireddine.benmammar@ch-lepuy.fr
Kheir Eddine BENMAMMAR
- Not yet recruiting
Hôpital Franco-Britannique
Levallois-Perret
Benoist CHIBAUDEL, 01 47 59 19 24, benoist.chibaudel@ihfb.org
Benoist CHIBAUDEL
- Not yet recruiting
CHU Dupuytren
Limoges
Frederic THUILLIER, 05 55 05 63 96, frederic.thuillier@chu-limoges.fr
Frederic THUILLIER
- Not yet recruiting
Groupement Hospitalier Bretagne Sud
Lorient
EDWINA GIRARD, 0297069695, e.girard@ghbs.bzh
EDWINA GIRARD
- Not yet recruiting
Hôpital Prive Jean Mermoz
Lyon, 69008
Jérôme DESRAME, Pr, 04 37 53 87 26, jerome.desrame@orange.fr
Jérôme DESRAME
- Not yet recruiting
Chu - Hôpital La Timone
Marseille, 13385
Laétitia DAHAN, Pr, +33 4 91 38 60 23, laetitia.dahan@ap-hm.fr
Laétitia DAHAN
- Not yet recruiting
CAC Paoli Calmettes
Marseille
Christelle DE LA FOUCHARDIERE, 06 64 44 05 39, delafouchardierec@ipc.unicancer.fr
Christelle DE LA FOUCHARDIERE
- Not yet recruiting
Confluent Sas
Nantes
Benjamin LINOT, MD, 02 28 27 22 38, benjamin.linot@groupeconfluent.fr
Benjamin LINOT
- Not yet recruiting
CAC Antoine Lacassagne
Nice
Claire JARAUDIAS, 0492031566, claire.jaraudias@nice.unicancer.fr
Claire JARAUDIAS
- Not yet recruiting
Gh Nord Essone
Orsay
Andreï HAVASI, 0169159127, a.havasi@ghne.fr
Andreï HAVASI
- Not yet recruiting
Privé - Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020
Olivier DUBREUIL, Dr, +33 1 44 74 28 39, ODubreuil@hopital-dcss.org
Olivier DUBREUIL
- Not yet recruiting
Chu - Aphp - Hôpital Saint Louis
Paris, 75475
Thomas APARICIO, Pr, 0142499597, thomas.aparicio@aphp.fr
Thomas APARICIO
- Not yet recruiting
Chu - Hôpital Européen Georges Pompidou
Paris
Aziz ZAANAN, 01 49 09 50 64, aziz.zaanan@aphp.fr
Aziz ZAANAN
- Not yet recruiting
Hôpital Cochin (APHP)
Paris
Romain CORIAT, 01 58 41 19 52, romain.coriat@aphp.fr
ROMAIN CORIAT
- Not yet recruiting
Centre Hospitalier
Pau, 64046
Juliette THAURY, Dr, 05 59 92 49 83, juliette.thaury@ch-pau.fr
Juliette THAURY
- Not yet recruiting
Centre Hospitalier Saint Jean
Perpignan
Faiza KHEMISSA AKOUZ, 0468616137, faiza.khemissa@ch-perpignan.fr
Faiza KHEMISSA AKOUZ
- Not yet recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Chloé VENTURIN, 04.78.86.12.91, chloe.venturin01@chu-lyon.fr
Chloé VENTURIN
- Recruiting
Chu - Centre Hospitalier Universitaire de Poitiers - La Miletrie
Poitiers, 86021
David TOUGERON, Pr, +33 5 49 44 37 51, david.tougeron@chu-poitiers.fr
David TOUGERON
- Not yet recruiting
Clinique de La Croix du Sud
Quint-Fonsegrives
Anne-Pascale LAURENTY, 05 32 02 72 44, anne-pascale.laurenty@ramsaysante.fr
Anne-Pascale LAURENTY
- Not yet recruiting
Chu - Centre Hospitalier Universitaire Robert Debre
Reims, 51092
Olivier BOUCHE, Pr, +33 3 26 78 71 72, obouche@chu-reims.fr
Olivier BOUCHE
- Not yet recruiting
CAC Jean Godinot
Reims
Damien BOTSEN, 03 26 78 71 70, dbotsen@chu-reims.fr
Damien BOTSEN
- Not yet recruiting
Centre Eugène Marquis
Rennes
Samuel LE SOURD, 02 99 25 31 96, s.lesourd@rennes.unicancer.fr
Samuel LE SOURD
- Not yet recruiting
Polyclinique
Rillieux-la-Pape
Matthieu SARABI, 0481764470, m.sarabi@gelmad.fr
Matthieu SARABI
- Not yet recruiting
CHU - Charles Nicolle
Rouen
Frédéric DI FIORE, 02 32 88 86 10, Frederic.Di-Fiore@chu-rouen.fr
Frédéric DI FIORE
- Not yet recruiting
Clinique Mathilde
Rouen
Romain KOKORIAN, +332 32 81 15 48, romkokorian@hotmail.fr
Romain KOKORIAN
- Not yet recruiting
Centre Hospitalier Prive Saint Gregoire
Saint-Grégoire
Hortense DE SAINT BASILE, 02.99.23.33.94, hortense.destbasile@icrb.fr
Hortense DE SAINT BASILE
- Not yet recruiting
Ch Memorial France Etats Unis
Saint-Lô
Dingyu XIAO, 02 33 06 31 59, dingyu.xiao@ch-stlo.fr
Dingyu XIAO
- Not yet recruiting
Hia Begin
Saint-Mandé
Julie LAVOLE, 01.43.98.47.22, julie.lavole@intradef.gouv.fr
Julie LAVOLE
- Not yet recruiting
Clinique Mutualiste de L'Estuaire
Saint-Nazaire
Manon BAVEREZ, MD, 02 72 27 54 82, manon.baverez@hospigrandouest.fr
Manon BAVEREZ
- Not yet recruiting
CHU de Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270
Jean-Marc PHELIP, Pr, 04 77 82 86 19, j.marc.phelip@chu-st-etienne.fr
Jean-Marc PHELIP
- Not yet recruiting
Center Hospitalier de Sens
Sens, 89108
Huu Thanh LE, 07 50 81 80 18, HTLE@ch-sens.fr
Huu Thanh LE
- Not yet recruiting
Groupe Hospitalier Rance Emeraude
St-Malo
Anne-Sophie MOUSSADDAQ, 0299212226, A.MOUSSADDAQ@ch-stmalo.fr
Anne-Sophie MOUSSADDAQ
- Not yet recruiting
CAC - Paul Strauss
Strasbourg
Meher Ben ABDELGHANI, 03 88 25 24 85, mbenabdelghani@strasbourg.unicancer.fr
Meher Ben ABDELGHANI
- Not yet recruiting
Clinique Sainte Anne
Strasbourg
LOUIS MARIE DOURTHE, 0388453750, lm.dourthe@solcrr.org
LOUIS MARIE DOURTHE
- Not yet recruiting
Hôpital FOCH
Suresnes
Asmahane BENMAZIANE TEILLET, 01 46 25 28 64, basmahane@gmail.com
Asmahane BENMAZIANE TEILLET
- Not yet recruiting
Hia Sainte Anne
Toulon
Caroline PRIEUX-KLOTZ, 04 83 16 25 19, caroline.klotz@intradef.gouv.fr
Caroline PRIEUX-KLOTZ
- Not yet recruiting
CHRU de Tours - Hopital Trousseau
Tours, 37044
MORGANE CAULET, MD, 02 47 47 59 00, m.caulet@chu-tours.fr
MORGANE CAULET
- Not yet recruiting
CHRU Nancy Brabois
Vandœuvre-lès-Nancy
Marie MULLER, 0383155179, m.muller7@chru-nancy.fr
MARIE MULLER
- Not yet recruiting
Ch Nord Ouest
Villefranche-sur-Saône
Boris MOREL, MD, bomorel@hno.fr
Boris MOREL
Germany8 sites, 8 recruiting
- Not yet recruiting
Klinikum Chemnitz gGmbH
Chemnitz
Jack Chafic Chater Cure, +49 371 3330, juhle@uke.de
Jack Chafic Chater Cure
- Not yet recruiting
KEM/Evang. Kliniken Essen Mitte gGmbH
Essen
Christian Müller, +49 201 1740, r.bergfried@kem-med.com
Christian Müller
- Not yet recruiting
Krankenhaus Nordwest GmbH
Frankfurt
Thorsten GÖTZE, +49 69 76011, bankstahl.ulli@khnw.de
Thorsten Götze
- Not yet recruiting
Haematologisch Onkologische Praxis Eppendorf
Hamburg
Alexander STEIN, 40360352222, info@hope-hamburg.de
Alexander STEIN
- Not yet recruiting
Universitätsklinikum Jena
Jena
Udo Lindig, +49 3641 9-324201, Diana.kathe@med.uni-jena.de
Udo Lindig
- Not yet recruiting
Uniklinikum Leipzig
Leipzig
Gertraud Stocker, +49 341 97109, Sabine.Falz@medizin.uni-leipzig.de
Gertraud Stocker
- Not yet recruiting
Klinikum Rechts Der Isar Der Technischen Universitat Munchen
München
Sylvie Lorenzen, +49 89 41400, sarah.lang@mri.tum.de
Sylvie Lorenzen
- Not yet recruiting
Rostock University Medical Center
Rostock
Hartmut GLÄSER, +49 381 4940, julia.gruen@med.uni-rostock.de
Hartmut GLÄSER
About this study
Official title: Randomized Phase III Trial to Compare Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma
Advanced cancer of the stomach and the gastro-esophageal junction (G/GEJ) remains a very serious disease. Today, only about 10-15% of patients are alive after 5 years. Treatments mainly aim to control symptoms, extend life, and maintain quality of life.
First treatments usually combine two chemotherapies, but recent years have brought real progress. Immunotherapy - drugs that "unlock" the immune system - has shown clear benefits. For patients whose tumors have certain markers (like PD-L1), combining drugs such as nivolumab or pembrolizumab with chemotherapy can help patients live longer. Another breakthrough is zolbetuximab, a targeted therapy that attacks a protein (Claudin 18.2) found on many gastric cancers, also improving survival.
Read more
When cancer grows despite these therapies, second-line treatments are used. The most common is chemotherapy with paclitaxel + ramucirumab, which blocks the tumor's blood supply. These drugs extend survival, but usually only by a few months.
For patients who need a third option, the oral drug trifluridine/tipiracil (TAS-102) can provide extra time, though benefits remain limited. That's why researchers are now exploring combinations. Since stomach tumors rely on forming new blood vessels, combining trifluridine/tipiracil with anti-angiogenic drugs - medicines that cut off the tumor's blood supply - looks promising.
One of the most exciting of these drugs is fruquintinib, already proven effective in colorectal cancer. A new international trial, FRUQUITAS (ENGIC 06/PRODIGE 114), is now testing whether adding fruquintinib to trifluridine/tipiracil can improve survival for patients with advanced stomach or gastro-esophageal cancer.
- Conditions
- Metastatic Oesogastric Adenocarcinoma
- Being tested
- trifluridine/tipiracil, fruquintinib
- Keywords
- Cancer, Fruquintinib, oeso-gastric, third line
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trifluridine/tipiracilDrug
Cycle of 28 days 35 mg/m2 by mouth twice daily on Days 1 to 5, 2 days of rest and 35 mg/m2 by mouth twice daily on days 8 to 12 Treatment will be repeated every 4 weeks until radiological disease progression, unacceptable toxicity or patient's refusal.
fruquintinibDrug
For fruquintinib: 5 mg by mouth once daily Day 1 to Day 21 (3 weeks) Treatment will be repeated every 4 weeks until radiological disease progression, unacceptable toxicity or patient's refusal.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (control arm): trifluridine/tipiracil | Active comparator | Cycle of 28 days 35 mg/m2 by mouth twice daily on Days 1 to 5, 2 days of rest and 35 mg/m2 by mouth twice daily on days 8 to 12 Receives: Drug: trifluridine/tipiracil |
| Arm B (experimental arm): trifluridine/tipiracil + fruquintinib | Experimental | Cycle of 28 days
For trifluridine/tipiracil: 35 mg/m2 by mouth twice daily on Day 1 to 5, 2 days of rest and 35 mg/m2 by mouth twice daily on days 8 to 12
For fruquintinib: 5 mg by mouth once daily Day 1 to Day 21 (3 weeks) Treatment will be repeated every 4 weeks until radiological disease progression, unacceptable toxicity or patient's refusal. Receives: Drug: trifluridine/tipiracil; Drug: fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The primary endpoint is the Overall survival (OS) and is defined as the time between the date of randomization and the date of death caused by any reason or the date of last news if the patient is alive.
Measured: up to 18 months after randomization
Secondary outcomes (1)
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time between date of randomization and the date of first radiological progression according to RECIST 1.1 or death (whichever occurs first). Patients alive without progression will be censored to the date of last radiologic assessment.
Measured: Up 18 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start15 Dec 2025
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Oesogastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Development Center Americas, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270991
- Sponsor's protocol ID
- ENGIC06-PRODIGE114-FRUQUITAS
- Other IDs
- 2025-522395-92-00, 2025
- Acronym
- FRUQUITAS
- Status last verified
- Feb 2025
- First submitted
- 24 Nov 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial to Compare Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07270991
- Acronym / sponsor ID
- FRUQUITAS / ENGIC06-PRODIGE114-FRUQUITAS
- Conditions
- Metastatic Oesogastric Adenocarcinoma
- Keywords
- Cancer, Fruquintinib, oeso-gastric, third line
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Collaborators
- Takeda Development Center Americas, Inc.
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Advanced cancer of the stomach and the gastro-esophageal junction (G/GEJ) remains a very serious disease. Today, only about 10-15% of patients are alive after 5 years. Treatments mainly aim to control symptoms, extend life, and maintain quality of life.
First treatments usually combine two chemotherapies, but recent years have brought real progress. Immunotherapy - drugs that "unlock" the immune system - has shown clear benefits. For patients whose tumors have certain markers (like PD-L1), combining drugs such as nivolumab or pembrolizumab with chemotherapy can help patients live longer. Another breakthrough is zolbetuximab, a targeted therapy that attacks a protein (Claudin 18.2) found on many gastric cancers, also improving survival.
When cancer grows despite these therapies, second-line treatments are used. The most common is chemotherapy with paclitaxel + ramucirumab, which blocks the tumor's blood supply. These drugs extend survival, but usually only by a few months.
For patients who need a third option, the oral drug trifluridine/tipiracil (TAS-102) can provide extra time, though benefits remain limited. That's why researchers are now exploring combinations. Since stomach tumors rely on forming new blood vessels, combining trifluridine/tipiracil with anti-angiogenic drugs - medicines that cut off the tumor's blood supply - looks promising.
One of the most exciting of these drugs is fruquintinib, already proven effective in colorectal cancer. A new international trial, FRUQUITAS (ENGIC 06/PRODIGE 114), is now testing whether adding fruquintinib to trifluridine/tipiracil can improve survival for patients with advanced stomach or gastro-esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (control arm): trifluridine/tipiracil | Active comparator | Drug: trifluridine/tipiracilCycle of 28 days 35 mg/m2 by mouth twice daily on Days 1 to 5, 2 days of rest and 35 mg/m2 by mouth twice daily on days 8 to 12 |
| Arm B (experimental arm): trifluridine/tipiracil + fruquintinib | Experimental | Drug: trifluridine/tipiracil, Drug: fruquintinibCycle of 28 days For trifluridine/tipiracil: 35 mg/m2 by mouth twice daily on Day 1 to 5, 2 days of rest and 35 mg/m2 by mouth twice daily on days 8 to 12 For fruquintinib: 5 mg by mouth once daily Day 1 to Day 21 (3 weeks) Treatment will be repeated every 4 weeks until radiological disease progression, unacceptable toxicity or patient's refusal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years (patients enrolled gender independently).
- Histologically proven metastatic adenocarcinoma of the stomach or the esophagogastric junction (GEJ) or esophagus.
- 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).
- 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).
- Measurable or non-measurable lesions. (Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Key exclusion criteria (23 listed)
- 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.
- Administration of the last dose of anticancer therapy and palliative radiotherapy ≤ 2 weeks prior to the first dose of study drug.
- Current or prior bowel obstruction within 28 days before the first dose of study drugs.
- Any unresolved clinical significant toxicity NCI CTCAE v5.0 ≥ grade 2 from previous anticancer therapy (except neuropathy).
- More than 3 prior lines of treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trifluridine/tipiracilCycle of 28 days 35 mg/m2 by mouth twice daily on Days 1 to 5, 2 days of rest and 35 mg/m2 by mouth twice daily on days 8 to 12 Treatment will be repeated every 4 weeks until radiological disease progression, unacceptable toxicity or patient's refusal. | Drug | Arm A (control arm): trifluridine/tipiracil, Arm B (experimental arm): trifluridine/tipiracil + fruquintinib |
| fruquintinibFor fruquintinib: 5 mg by mouth once daily Day 1 to Day 21 (3 weeks) Treatment will be repeated every 4 weeks until radiological disease progression, unacceptable toxicity or patient's refusal. | Drug | Arm B (experimental arm): trifluridine/tipiracil + fruquintinib |
Primary outcome
Overall survival
Time frame: up to 18 months after randomization
The primary endpoint is the Overall survival (OS) and is defined as the time between the date of randomization and the date of death caused by any reason or the date of last news if the patient is alive.
1 secondary outcome
Progression-free survival (PFS)
Time frame: Up 18 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Metastatic Oesogastric Adenocarcinoma
Active, not recruitingPhase 2
Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer
Gastric Adenocarcinoma, Esophagus Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
64 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing trifluridine/tipiracil and fruquintinib in people with Metastatic Oesogastric Adenocarcinoma, run by Federation Francophone de Cancerologie Digestive at 64 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project manager (+33(0)3 80 66 80 13, prodige114.fruquitas@ffcd.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to 18 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.