What is this trial studying for metastatic oesogastric adenocarcinoma?

This trial is studying whether adding fruquintinib to the oral drug trifluridine/tipiracil can improve survival for patients with advanced stomach or gastro-esophageal cancer. Researchers want to find better treatment options after other therapies have been tried. The study is sponsored by the Federation Francophone de Cancerologie Digestive.

Who may be eligible for this metastatic oesogastric adenocarcinoma clinical trial?

Adults aged 18 years or older with metastatic adenocarcinoma of the stomach, esophagogastric junction, or esophagus may be eligible. Participants should have had two or three prior treatments for metastatic disease and a good performance status. The trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic oesogastric adenocarcinoma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07270991

Randomized Phase III Trial Comparing TrifluridineTipiracil Plus Fruquintinib Versus TrifluridineTipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma

Led by Federation Francophone de Cancerologie Digestive · Updated on 2026-02-05

324

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying advanced cancer of the stomach and the gastro-esophageal junction, a serious disease with low survival rates. The trial focuses on patients whose cancer has progressed after two or three prior treatments. The study aims to evaluate whether combining the oral drug trifluridinetipiracil with the anti-angiogenic drug fruquintinib can improve survival compared to trifluridinetipiracil alone. This international Phase III trial builds on recent advances in immunotherapy and targeted therapies for this cancer type. Participants are randomly assigned to one of two groups. One group receives trifluridinetipiracil alone in 28-day cycles, taking the drug by mouth twice daily on Days 1 to 5 and Days 8 to 12 with rest days in between, repeated every 4 weeks. The other group receives the same trifluridinetipiracil schedule plus fruquintinib by mouth once daily for 21 days each cycle. Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant chooses to stop. During the study, participants undergo regular assessments to monitor overall survival up to 18 months after starting treatment. Researchers will also measure progression-free survival during this period. Patients will have tumor evaluations, laboratory tests, and monitoring for treatment side effects. Participants must meet specific health criteria and agree to biological studies. The study provides close follow-up to evaluate the effects of the treatments over time.

CONDITIONS

Brief Title

Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older at enrollment
Diagnosed with histologically proven metastatic adenocarcinoma of the stomach, esophagogastric junction, or esophagus
Received two or three prior lines of treatment for metastatic disease
Prior treatment must include 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 according to RECIST 1.1 criteria
WHO performance status of 0 or 1
Adequate organ function (specific blood counts, liver enzymes, bilirubin, and kidney function as defined)
Adequate coagulation tests unless on anticoagulants
Post-menopausal status or negative pregnancy test for pre-menopausal women
Agreement to use two medically acceptable contraception methods during and for 6 months after treatment
Ability to understand and sign informed consent
Availability of tumor block samples
Willingness to participate in biological studies

You will not qualify if you...

Enrolled in another clinical study unless observational or follow-up only
Received anticancer therapy or palliative radiotherapy within 2 weeks before study drug
Current or recent bowel obstruction within 28 days before treatment start
Unresolved significant toxicity grade 2 or higher from previous therapy except neuropathy
More than three prior lines of treatment
Major surgery within 2 weeks before treatment start
History of leptomeningeal carcinomatosis or symptomatic untreated brain metastases
Severe cardiac disorders within 6 months
Severe liver dysfunction (Child Pugh B or C cirrhosis)
Active gastric or duodenal ulcer
Thromboembolic events in past 6 months
Uncontrolled illness including infection, hypertension, lung disease, or serious gastrointestinal conditions
Psychiatric or social conditions limiting compliance or consent ability
Significant proteinuria
Positive test for HIV, active hepatitis B or C, or active tuberculosis
Allergy or hypersensitivity to study drugs or excipients
Prior treatment with trifluridine/tipiracil, fruquintinib, regorafenib, or anti-VEGFR inhibitors
Active infection requiring intravenous antibiotics at treatment start
Other malignancy within 3 years except certain localized cancers
Treatment with strong CYP 450 inducers
Pregnant or breastfeeding
Certain metabolic disorders including galactosemia or lactose intolerance
Clinically significant bleeding in past 2 months

Research Team

Project manager

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