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ENGIC 06 (PRODIGE 114) – FFCD 2401 – FRUQUITAS Randomized phase III trial to compare trifluridine/tipiracil + Fruquintinib versus trifluridine/tipiracil alone for metastatic oeso-gastric adenocarcinoma.
EU CTIS ID: 2025-522395-92-00
What this study is testing
To compare OS between trifluridine/tipiracil plus fruquintinib (Arm B) versus trifluridine/tipiracil alone (Arm A)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years (patients enrolled gender independently).
- 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 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
- Histologically proven metastatic adenocarcinoma of the stomach or the esophagogastric junction (GEJ) or esophagus.
You likely can't join if
- 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.
- 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.
See the full eligibility criteria
Who can join
- Age ≥ 18 years (patients enrolled gender independently).
- 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 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
- 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.
- 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.
What rules you out
- 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.
- 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.
- Administration of the last dose of anticancer therapy and palliative radiotherapy ≤ 2 weeks prior to the first dose of study drug.
- 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.
- 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.
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.