Actively Recruiting
Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma
Led by Federation Francophone de Cancerologie Digestive · Updated on 2026-02-05
324
Participants Needed
64
Research Sites
258 weeks
Total Duration
On this page
Sponsors
F
Federation Francophone de Cancerologie Digestive
Lead Sponsor
T
Takeda Development Center Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed metastatic adenocarcinoma of the stomach, esophagogastric junction, or esophagus
- Received two or three prior treatment lines for metastatic disease
- Prior treatment with platinum salts, fluoropyrimidine, irinotecan and/or taxane, with or without anti-HER2 agents, immune checkpoint inhibitors, ramucirumab, or anti-claudin 18.2
- Measurable or non-measurable lesions as per RECIST 1.1 criteria
- WHO performance status of 0 or 1
- Adequate organ function including ANC ≥ 1.5 x 10^9/L, hemoglobin ≥ 9 g/dL, platelets ≥ 100 G/L, liver enzymes ≤ 3 x ULN (or ≤ 5 x ULN if liver metastases), total bilirubin ≤ 1.5 x ULN, creatinine clearance > 30 mL/min
- Adequate coagulation tests unless receiving anticoagulant therapy
- Post-menopausal status or negative pregnancy test for pre-menopausal females
- Agreement to use two medically acceptable methods of contraception during the study and for 6 months after treatment
- Ability to understand and sign informed consent
- Availability of tumor tissue samples
- Willingness to participate in biological studies
You will not qualify if you...
- Participation in another interventional clinical study (except observational or follow-up studies)
- Anticancer therapy or palliative radiotherapy within 2 weeks before starting study drug
- Current or recent bowel obstruction within 28 days before treatment
- Unresolved moderate or severe toxicity from prior therapies (except neuropathy)
- More than three prior lines of treatment
- Major surgery within 2 weeks before treatment
- History of leptomeningeal carcinomatosis or symptomatic/untreated brain metastases
- Severe cardiac disorders within 6 months, including heart attack, stroke, unstable angina, heart failure with LVEF < 50%
- Severe liver dysfunction (Child Pugh B or C cirrhosis)
- Active gastric or duodenal ulcer
- Thromboembolic events in the past 6 months
- Uncontrolled illnesses such as active infection, uncontrolled hypertension, interstitial lung disease, or serious gastrointestinal conditions with diarrhea
- Psychiatric or social conditions limiting study compliance or consent
- Significant proteinuria (urine protein ≥ 2+ or ≥ 1.0 g/24h)
- Known HIV, active hepatitis B or C, or active tuberculosis
- Allergy to study drugs or excipients including tartrazine, sunset yellow FCF, or lactose monohydrate
- Prior treatment with trifluridine/tipiracil, fruquintinib, regorafenib, or anti-VEGFR tyrosine kinase inhibitors
- Active infection requiring intravenous antibiotics at treatment start
- Other malignancies within 3 years except certain localized cancers
- Treatment with strong CYP 450 inducers
- Pregnant or breastfeeding females
- Certain metabolic disorders such as galactosemia or lactose intolerance
- Clinically significant bleeding within 2 months prior to study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 64 locations
1
Centre Hospitalier
Aurillac, France
Not Yet Recruiting
2
Institut Sainte Catherine
Avignon, France, 84000
Not Yet Recruiting
3
Centre Hospitalier
Bayeux, France
Not Yet Recruiting
4
Bayonne- Clinique Belharra
Bayonne, France
Not Yet Recruiting
5
Centre Hospitalier Côte Basque
Bayonne, France
Not Yet Recruiting
6
ICONE
Bezannes, France
Not Yet Recruiting
7
BORDEAUX-Institut Bergonié
Bordeaux, France
Not Yet Recruiting
8
Clinique Tivoli
Bordeaux, France
Not Yet Recruiting
9
C.H.U. de Brest
Brest, France, 29200
Not Yet Recruiting
10
Cac - François Baclesse
Caen, France
Not Yet Recruiting
11
CHU Côte de Nacre
Caen, France
Not Yet Recruiting
12
Ch - Jean Rougier
Cahors, France
Not Yet Recruiting
13
Centre Hospitalier
Cholet, France
Not Yet Recruiting
14
Saint Côme
Compiègne, France
Not Yet Recruiting
15
Clinique de Flandre
Coudekerque-Branche, France
Not Yet Recruiting
16
Centre Leonard de Vinci
Dechy, France
Not Yet Recruiting
17
Institut de cancérologie de Bourgogne GRReCC
Dijon, France
Not Yet Recruiting
18
Centre Hospitalier Emile Roux
Le Puy-en-Velay, France
Not Yet Recruiting
19
Hôpital Franco-Britannique
Levallois-Perret, France
Not Yet Recruiting
20
CHU Dupuytren
Limoges, France
Not Yet Recruiting
21
Groupement Hospitalier Bretagne Sud
Lorient, France
Not Yet Recruiting
22
Hôpital Prive Jean Mermoz
Lyon, France, 69008
Not Yet Recruiting
23
Chu - Hôpital La Timone
Marseille, France, 13385
Not Yet Recruiting
24
CAC Paoli Calmettes
Marseille, France
Not Yet Recruiting
25
Confluent Sas
Nantes, France
Not Yet Recruiting
26
CAC Antoine Lacassagne
Nice, France
Not Yet Recruiting
27
Gh Nord Essone
Orsay, France
Not Yet Recruiting
28
Privé - Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, France, 75020
Not Yet Recruiting
29
Chu - Aphp - Hôpital Saint Louis
Paris, France, 75475
Not Yet Recruiting
30
Chu - Hôpital Européen Georges Pompidou
Paris, France
Not Yet Recruiting
31
Hôpital Cochin (APHP)
Paris, France
Not Yet Recruiting
32
Centre Hospitalier
Pau, France, 64046
Not Yet Recruiting
33
Centre Hospitalier Saint Jean
Perpignan, France
Not Yet Recruiting
34
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Not Yet Recruiting
35
Chu - Centre Hospitalier Universitaire de Poitiers - La Miletrie
Poitiers, France, 86021
Actively Recruiting
36
Clinique de La Croix du Sud
Quint-Fonsegrives, France
Not Yet Recruiting
37
Chu - Centre Hospitalier Universitaire Robert Debre
Reims, France, 51092
Not Yet Recruiting
38
CAC Jean Godinot
Reims, France
Not Yet Recruiting
39
Centre Eugène Marquis
Rennes, France
Not Yet Recruiting
40
Polyclinique
Rillieux-la-Pape, France
Not Yet Recruiting
41
CHU - Charles Nicolle
Rouen, France
Not Yet Recruiting
42
Clinique Mathilde
Rouen, France
Not Yet Recruiting
43
Centre Hospitalier Prive Saint Gregoire
Saint-Grégoire, France
Not Yet Recruiting
44
Ch Memorial France Etats Unis
Saint-Lô, France
Not Yet Recruiting
45
Hia Begin
Saint-Mandé, France
Not Yet Recruiting
46
Clinique Mutualiste de L'Estuaire
Saint-Nazaire, France
Not Yet Recruiting
47
CHU de Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, France, 42270
Not Yet Recruiting
48
Center Hospitalier de Sens
Sens, France, 89108
Not Yet Recruiting
49
Groupe Hospitalier Rance Emeraude
St-Malo, France
Not Yet Recruiting
50
CAC - Paul Strauss
Strasbourg, France
Not Yet Recruiting
51
Clinique Sainte Anne
Strasbourg, France
Not Yet Recruiting
52
Hôpital FOCH
Suresnes, France
Not Yet Recruiting
53
Hia Sainte Anne
Toulon, France
Not Yet Recruiting
54
CHRU de Tours - Hopital Trousseau
Tours, France, 37044
Not Yet Recruiting
55
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, France
Not Yet Recruiting
56
Ch Nord Ouest
Villefranche-sur-Saône, France
Not Yet Recruiting
57
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Not Yet Recruiting
58
KEM/Evang. Kliniken Essen Mitte gGmbH
Essen, Germany
Not Yet Recruiting
59
Krankenhaus Nordwest GmbH
Frankfurt, Germany
Not Yet Recruiting
60
Haematologisch Onkologische Praxis Eppendorf
Hamburg, Germany
Not Yet Recruiting
61
Universitätsklinikum Jena
Jena, Germany
Not Yet Recruiting
62
Uniklinikum Leipzig
Leipzig, Germany
Not Yet Recruiting
63
Klinikum Rechts Der Isar Der Technischen Universitat Munchen
München, Germany
Not Yet Recruiting
64
Rostock University Medical Center
Rostock, Germany
Not Yet Recruiting
Research Team
P
Project manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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