Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
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.
Eligibility
Primary outcome measure(s)
- Overall survival — 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.
Trial sites (64)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Hospitalier | Aurillac | France | Not Yet Recruiting |
| Institut Sainte Catherine | Avignon | France | Not Yet Recruiting |
| Centre Hospitalier | Bayeux | France | Not Yet Recruiting |
| Bayonne- Clinique Belharra | Bayonne | France | Not Yet Recruiting |
| Centre Hospitalier Côte Basque | Bayonne | France | Not Yet Recruiting |
| ICONE | Bezannes | France | Not Yet Recruiting |
| BORDEAUX-Institut Bergonié | Bordeaux | France | Not Yet Recruiting |
| Clinique Tivoli | Bordeaux | France | Not Yet Recruiting |
| C.H.U. de Brest | Brest | France | Not Yet Recruiting |
| Cac - François Baclesse | Caen | France | Not Yet Recruiting |
| CHU Côte de Nacre | Caen | France | Not Yet Recruiting |
| Ch - Jean Rougier | Cahors | France | Not Yet Recruiting |
| Centre Hospitalier | Cholet | France | Not Yet Recruiting |
| Saint Côme | Compiègne | France | Not Yet Recruiting |
| Clinique de Flandre | Coudekerque-Branche | France | Not Yet Recruiting |
| Centre Leonard de Vinci | Dechy | France | Not Yet Recruiting |
| Institut de cancérologie de Bourgogne GRReCC | Dijon | France | Not Yet Recruiting |
| Centre Hospitalier Emile Roux | Le Puy-en-Velay | France | Not Yet Recruiting |
| Hôpital Franco-Britannique | Levallois-Perret | France | Not Yet Recruiting |
| CHU Dupuytren | Limoges | France | Not Yet Recruiting |
| Groupement Hospitalier Bretagne Sud | Lorient | France | Not Yet Recruiting |
| Hôpital Prive Jean Mermoz | Lyon | France | Not Yet Recruiting |
| Chu - Hôpital La Timone | Marseille | France | Not Yet Recruiting |
| CAC Paoli Calmettes | Marseille | France | Not Yet Recruiting |
| Confluent Sas | Nantes | France | Not Yet Recruiting |
| CAC Antoine Lacassagne | Nice | France | Not Yet Recruiting |
| Gh Nord Essone | Orsay | France | Not Yet Recruiting |
| Privé - Groupe Hospitalier Diaconesses Croix Saint Simon | Paris | France | Not Yet Recruiting |
| Chu - Aphp - Hôpital Saint Louis | Paris | France | Not Yet Recruiting |
| Chu - Hôpital Européen Georges Pompidou | Paris | France | Not Yet Recruiting |
| Hôpital Cochin (APHP) | Paris | France | Not Yet Recruiting |
| Centre Hospitalier | Pau | France | Not Yet Recruiting |
| Centre Hospitalier Saint Jean | Perpignan | France | Not Yet Recruiting |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | France | Not Yet Recruiting |
| Chu - Centre Hospitalier Universitaire de Poitiers - La Miletrie | Poitiers | France | Recruiting |
| Clinique de La Croix du Sud | Quint-Fonsegrives | France | Not Yet Recruiting |
| Chu - Centre Hospitalier Universitaire Robert Debre | Reims | France | Not Yet Recruiting |
| CAC Jean Godinot | Reims | France | Not Yet Recruiting |
| Centre Eugène Marquis | Rennes | France | Not Yet Recruiting |
| Polyclinique | Rillieux-la-Pape | France | Not Yet Recruiting |
+ 24 more sites — see the full list on the official registry below.
More Federation Francophone de Cancerologie Digestive trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07270991 on ClinicalTrials.gov ↗ ← All trials in Germany