A study comparing trifluridine, tipiracil, and fruquintinib versus trifluridine and tipiracil alone for patients with metastatic stomach or esophageal cancer
This study is looking at metastatic oeso-gastric adenocarcinoma, which is a type of cancer that has spread and affects the stomach, the area where the esophagus meets the stomach, or the esophagus itself. The treatments being tested include trifluridine combined with tipiracil hydrochloride, which is a medicine sold as Lonsurf, and fruquintinib, which is sold as FRUZAQLA. These medicines are taken by mouth as tablets or capsules. The study will compare two treatment approaches: one group will receive Lonsurf together with FRUZAQLA, while another group will receive only Lonsurf. This study includes patients who have already received two or three previous treatments for their cancer that included certain types of chemotherapy medicines.
The main purpose of this study is to find out if adding FRUZAQLA to Lonsurf helps people live longer compared to taking Lonsurf alone. The study will also look at how long patients live without their cancer getting worse, how well the tumors respond to treatment, and how the treatments affect quality of life. The safety of the treatments will be carefully monitored, and any side effects will be recorded. Patients will be assigned randomly to one of the two treatment groups, meaning that neither the patient nor the doctor chooses which treatment is given.
During the study, patients will take their assigned medicines for up to six months, and their health will be regularly checked through medical examinations and scans to see how the cancer is responding. Quality of life will be measured using questionnaires that ask about daily activities and symptoms. The study is expected to start enrolling patients in early 2026 and continue until early 2029. Patients will need to provide tumor tissue samples for testing and agree to participate in additional biological studies as part of the research.
1Treatment assignment
After joining the study, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures fairness in treatment distribution.
You will receive either trifluridine/tipiracil alone (Group A) or trifluridine/tipiracil combined with fruquintinib (Group B).
2Treatment with medications
If you are assigned to Group A, you will take trifluridine/tipiracil tablets by mouth. This medication is available as film-coated tablets in two strengths: 15 mg/6.14 mg and 20 mg/8.19 mg.
If you are assigned to Group B, you will take both trifluridine/tipiracil tablets and fruquintinib capsules by mouth. The fruquintinib capsules are available in two strengths: 1 mg and 5 mg.
All medications are taken orally, meaning you will swallow them by mouth.
The specific dosage, frequency, and duration of treatment will be determined by the study protocol and your medical team, but these details are not specified in the available information.
3Regular monitoring and assessments
Throughout the study, you will undergo regular medical assessments to monitor how the treatment is affecting you and your condition.
These assessments will include imaging scans to check if the cancer is responding to treatment, staying stable, or progressing. The scans will be evaluated using standard criteria called RECIST 1.1, which is a method doctors use to measure tumor size changes.
Your medical team will monitor you for any side effects or adverse events. Any side effects will be classified according to a standardized system called NCI-CTCAE version 5.0, which helps describe the severity of side effects.
Regular blood tests will be performed to check your organ function, including blood cell counts, liver function, kidney function, and blood clotting ability.
4Quality of life assessments
During the study, you will be asked to complete questionnaires about your quality of life at various timepoints.
These questionnaires are called EORTC QLQ-C30 and STO22. They ask questions about your physical health, emotional well-being, and symptoms related to your condition.
Your responses will help researchers understand how the treatment affects your daily life and overall well-being.
5Response evaluation
Your response to treatment will be assessed at specific time intervals, including at 2, 3, 6, and 9 months.
The medical team will determine whether your tumors have completely disappeared (complete response), partially shrunk (partial response), remained stable (stable disease), or grown (progressive disease).
The best response you achieve during treatment will be recorded.
6Continuation of treatment
You will continue taking the assigned medication(s) as long as the treatment is helping control your disease and you are not experiencing unacceptable side effects.
If your cancer progresses or if side effects become too severe, the treatment may be stopped or modified.
7Long-term follow-up
The study will continue to monitor your health status over time, even after treatment ends.
The main focus of this monitoring is to track overall survival, which measures how long patients live from the time they joined the study.
The study is expected to run until January 2029, though individual participation duration may vary.
Who Can Join the Study?
Requirements to participate in this clinical trial:
You must be 18 years of age or older
Both men and women can participate in this study
If you are able to have children, both you and your partner must use reliable birth control methods during the study and for 6 months after the last dose of the study treatment
You must be able to understand and sign a consent form before any study procedures begin
A sample of your tumor tissue must be available from a previous surgery or biopsy, which is a procedure where a small piece of tissue is removed for testing
You must be willing to provide samples for additional laboratory research
You must have adenocarcinoma, a type of cancer that has been confirmed by laboratory examination of tissue, located in the stomach, the area where the esophagus meets the stomach, or the esophagus, and the cancer has spread to other parts of the body
You must have already received two or three previous treatment plans for cancer that has spread. If you received treatment after surgery and your cancer returned within 6 months, this counts as one treatment plan
You must have previously been treated with specific chemotherapy drugs including platinum-based drugs like oxaliplatin or cisplatin, fluoropyrimidine, and irinotecan and/or taxane, and your cancer either grew during treatment or you could not tolerate these treatments. You may also have received other targeted therapies or immunotherapies
Your cancer must be visible on imaging scans or detectable by other methods according to standard measurement criteria
Your overall physical condition must be good enough that you can care for yourself and are active more than half of your waking hours
Your blood tests must show adequate function: white blood cells that fight infection must be at least 1.5 billion per liter, hemoglobin which carries oxygen in your blood must be at least 9 grams per deciliter, platelets that help blood clot must be at least 100 billion per liter
Your liver function tests must be acceptable: liver enzymes called AST and ALT must be no more than 3 times the normal upper limit, or 5 times if cancer has spread to your liver, and bilirubin which is a waste product processed by the liver must be no more than 1.5 times the normal upper limit
Your kidney function must be adequate with a creatinine clearance, which measures how well your kidneys filter waste, greater than 30 milliliters per minute
Your blood clotting tests must be normal or only slightly elevated unless you are taking blood thinning medication
If you are a woman who could become pregnant, you must have a negative pregnancy test or show evidence that you have gone through menopause and can no longer become pregnant
Who Cannot Join the Study?
The source data does not provide specific exclusion criteria, which are the reasons why a patient cannot participate in the study
Without detailed exclusion criteria information, it is not possible to list specific medical conditions, treatments, or situations that would prevent participation
Typically, exclusion criteria may include things like other serious illnesses, certain medications being taken, pregnancy, or previous treatments, but these specific details are not available in the provided information
Trifluridine/tipiracil is a combination medication used to treat cancer. It works by interfering with the growth of cancer cells and helping to slow down or stop the spread of the disease in your body.
Fruquintinib is a cancer medication that works by blocking the formation of new blood vessels that tumors need to grow. By limiting the blood supply to the cancer, it helps to slow down the growth and spread of the tumor.
Metastatic Esophagogastric Adenocarcinoma – This is a type of cancer that begins in the glandular cells of the esophagus or stomach and has spread to other parts of the body. The disease starts when abnormal cells in the lining of these organs grow uncontrollably and form tumors. As the cancer progresses, it can spread through the lymphatic system or bloodstream to distant organs such as the liver, lungs, or bones. This spreading process is called metastasis, which marks an advanced stage of the disease. Patients may experience difficulty swallowing, weight loss, abdominal pain, and digestive problems as the condition advances. The cancer continues to grow in both the original site and the new locations where it has spread.
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