Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma
NCT ID: NCT07270991
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
324 participants
INTERVENTIONAL
2025-12-31
2030-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (control arm): trifluridine/tipiracil
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
trifluridine/tipiracil
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.
Arm B (experimental arm): trifluridine/tipiracil + fruquintinib
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.
trifluridine/tipiracil
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.
fruquintinib
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.
Interventions
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trifluridine/tipiracil
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.
fruquintinib
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Takeda Development Center Americas, Inc.
INDUSTRY
Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Locations
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Centre Hospitalier
Aurillac, , France
Institut Sainte Catherine
Avignon, , France
Centre Hospitalier
Bayeux, , France
Bayonne- Clinique Belharra
Bayonne, , France
Centre Hospitalier Côte Basque
Bayonne, , France
ICONE
Bezannes, , France
BORDEAUX-Institut Bergonié
Bordeaux, , France
Clinique Tivoli
Bordeaux, , France
C.H.U. de Brest
Brest, , France
Cac - François Baclesse
Caen, , France
CHU Côte de Nacre
Caen, , France
Ch - Jean Rougier
Cahors, , France
Centre Hospitalier
Cholet, , France
Saint Côme
Compiègne, , France
Clinique de Flandre
Coudekerque-Branche, , France
Centre Leonard de Vinci
Dechy, , France
Institut de cancérologie de Bourgogne GRReCC
Dijon, , France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, , France
Hôpital Franco-Britannique
Levallois-Perret, , France
CHU Dupuytren
Limoges, , France
Groupement Hospitalier Bretagne Sud
Lorient, , France
Hôpital Prive Jean Mermoz
Lyon, , France
Chu - Hôpital La Timone
Marseille, , France
CAC Paoli Calmettes
Marseille, , France
Confluent Sas
Nantes, , France
CAC Antoine Lacassagne
Nice, , France
Gh Nord Essone
Orsay, , France
Privé - Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, , France
Chu - Aphp - Hôpital Saint Louis
Paris, , France
Chu - Hôpital Européen Georges Pompidou
Paris, , France
Hôpital Cochin (APHP)
Paris, , France
Centre Hospitalier
Pau, , France
Centre Hospitalier Saint Jean
Perpignan, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Chu - Centre Hospitalier Universitaire de Poitiers - La Miletrie
Poitiers, , France
Clinique de La Croix du Sud
Quint-Fonsegrives, , France
Chu - Centre Hospitalier Universitaire Robert Debre
Reims, , France
CAC Jean Godinot
Reims, , France
Centre Eugène Marquis
Rennes, , France
Polyclinique
Rillieux-la-Pape, , France
CHU - Charles Nicolle
Rouen, , France
Clinique Mathilde
Rouen, , France
Centre Hospitalier Prive Saint Gregoire
Saint-Grégoire, , France
Ch Memorial France Etats Unis
Saint-Lô, , France
Hia Begin
Saint-Mandé, , France
Clinique Mutualiste de L'Estuaire
Saint-Nazaire, , France
CHU de Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, , France
Center Hospitalier de Sens
Sens, , France
Groupe Hospitalier Rance Emeraude
St-Malo, , France
CAC - Paul Strauss
Strasbourg, , France
Clinique Sainte Anne
Strasbourg, , France
Hôpital FOCH
Suresnes, , France
Hia Sainte Anne
Toulon, , France
CHRU de Tours - Hopital Trousseau
Tours, , France
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, , France
Ch Nord Ouest
Villefranche-sur-Saône, , France
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
KEM/Evang. Kliniken Essen Mitte gGmbH
Essen, , Germany
Krankenhaus Nordwest GmbH
Frankfurt, , Germany
Haematologisch Onkologische Praxis Eppendorf
Hamburg, , Germany
Universitätsklinikum Jena
Jena, , Germany
Uniklinikum Leipzig
Leipzig, , Germany
Klinikum Rechts Der Isar Der Technischen Universitat Munchen
München, , Germany
Rostock University Medical Center
Rostock, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-522395-92-00
Identifier Type: CTIS
Identifier Source: secondary_id
ENGIC06-PRODIGE114-FRUQUITAS
Identifier Type: -
Identifier Source: org_study_id
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