Study of Oxaliplatin, Nivolumab, and Trifluridine/Tipiracil for Patients with Advanced Gastric, Esophageal, or Gastroesophageal Junction Cancer

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What is this study about?

This clinical trial is focused on studying treatments for patients with advanced forms of cancer in the stomach, esophagus, or the area where the esophagus meets the stomach, known as the gastroesophageal junction. Specifically, it involves patients with a type of cancer called adenocarcinoma that does not have an excess of a protein called HER2. The study is comparing different combinations of medications to see which is more effective in stopping the cancer from getting worse. The medications being tested include trifluridine/tipiracil (known as Lonsurf), oxaliplatin, nivolumab, fluorouracil, levoleucovorin, folinic acid, and capecitabine. Some patients will receive a combination of these drugs, while others may receive a placebo.

The purpose of the study is to determine if the combination of trifluridine/tipiracil and oxaliplatin, with or without nivolumab, is better at delaying the progression of cancer compared to a regimen called FOLFOX, which includes fluorouracil, oxaliplatin, and folinic acid, with or without nivolumab. The study will follow patients over a period to monitor how their cancer responds to the treatment and to assess their overall health and quality of life. Patients will receive their assigned treatment and will be regularly monitored by healthcare professionals to track the progress of their disease and any side effects they may experience.

This trial aims to provide valuable information on the effectiveness and safety of these treatment combinations for patients with advanced gastric, esophageal, or gastroesophageal junction cancer. The results could help improve treatment options for these patients in the future.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of the treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the treatment options being tested.

2 treatment administration

The patient will receive one of the following treatment regimens:

Option 1: Trifluridine/Tipiracil plus Oxaliplatin with or without Nivolumab. Trifluridine/Tipiracil is taken orally in the form of film-coated tablets. Oxaliplatin and Nivolumab are administered as a concentrate for solution for infusion.

Option 2: FOLFOX regimen with or without Nivolumab. FOLFOX includes Fluorouracil, Levoleucovorin, and Oxaliplatin. Fluorouracil and Levoleucovorin are given as a solution for infusion, while Oxaliplatin is a concentrate for solution for infusion.

3 treatment schedule

The treatment will be administered in cycles. Each cycle typically lasts a few weeks, during which the patient will receive the medication on specific days followed by a rest period. The exact schedule will depend on the specific treatment regimen assigned.

4 monitoring and assessments

Throughout the trial, the patient’s health and response to treatment will be closely monitored. This includes regular medical check-ups, blood tests, and imaging studies to assess the progression of the disease and any side effects of the treatment.

5 completion of treatment

The treatment will continue until the disease progresses, unacceptable side effects occur, or the patient decides to withdraw from the study. The estimated end date for the trial is October 31, 2027.

6 follow-up

After completing the treatment, the patient will have follow-up visits to monitor their health and any long-term effects of the treatment. These visits will help gather information on the overall survival and quality of life of the participants.

Who Can Join the Study?

Patients must have a type of cancer called adenocarcinoma in the stomach, esophagus, or where the stomach and esophagus meet. This cancer must be advanced, have come back, or spread to other parts of the body, and cannot be removed by surgery.
Women who can have children must have a negative pregnancy test within 14 days before starting the study treatment.
Patients must agree to use reliable birth control methods during the study and for 6 months after finishing the treatment.
Patients must be part of a Social Security System or something similar.
Patients must sign a consent form to participate in the study. If they cannot sign, a trusted person can sign for them.
There must be available samples of the patient’s tumor for additional studies.
Patients should not have trouble swallowing.
The cancer should not have too much of a protein called HER2. The status of other proteins and genes related to the cancer must be known before starting the study.
Patients must have at least one area of cancer that can be measured and is not in a place that was treated with radiation before.
Patients should not have had chemotherapy for advanced cancer before.
Patients must be at least 18 years old.
Patients must be able to receive a type of chemotherapy called FOLFOX.
Patients must have organs that are working well, with specific levels of blood cells, liver enzymes, and kidney function.
Patients should not have a deficiency in an enzyme called DPD, which is important for processing certain drugs.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have received certain treatments for their cancer before.
Patients with serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures.
Patients who have allergies to the study medications.
Patients who are participating in another clinical trial.
Patients with a history of certain heart conditions.
Patients with active infections that require treatment.
Patients with a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Mco Cote D’Opale	Saint-Martin-Boulogne	France
Centre Jean Perrin	Clermont Ferrand	France
Clinique de Flandre	Coudekerque Branche	France
CHU de Rouen – Hôpital Charles Nicolle	Rouen	France
CHU d’Estaing	Clermont Ferrand	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Institut Sainte Catherine	Avignon	France
Clinique Pasteur Lanroze	Brest	France
Institut Godinot	Reims	France
Centre Hospitalier Bethune Beuvry	Beuvry	France
Clinique de l’Europe	Amiens	France
Hopital Saint Joseph	Marseille	France
Centre Hospitalier De Cholet	Cholet	France
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
Centre Hospitalier Simone Veil De Beauvais	Beauvais	France
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Clauvy Lcti Bkilse	Lyon	France
Csfukn Hzpqsowiulz Uqpgfzoxwgvzm Rjdsg	Reims	France
Irzimmab Mtcpgriyav Mddvcmcons	Paris	France
Hlswxnh Pkaee Aijhd Los Bfngjmujg	Arras	France
Hhnxkaz Nfmw Fvqxldg Czgzt	Montbéliard	France
Cuuten Hbbomxcutrc Ds Jhov Ehxq Twjaoo	Calais	France
Ctpvce Pzij Sqsbsto	STRASBOURG, Alsace	France
Cu Vsenndnkebgb Nkcp Okthl	Villefranche sur Saône	France
Anjxbkjonh Pgvwysqr Hmozckwx Dk Pdamp	Paris	France
Blzqfqkc Ummnboufxc Hnmcdsmn Cnkyxp	Besançon	France
Cnji Di Ncrbf	Vandoeuvre Les Nancy	France
Ijzougwo Pnwzjdjcwydpett Ckojzy Cchplo	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	23.06.2023

Trial locations

Investigated drugs:

Trifluridine/Tipiracil is a combination medication used in cancer treatment. It works by interfering with the DNA of cancer cells, preventing them from growing and multiplying. This medication is being tested to see if it can help patients with certain types of advanced stomach and esophageal cancers live longer without their disease getting worse.

Oxaliplatin is a chemotherapy drug that is used to treat various types of cancer, including stomach and esophageal cancers. It works by damaging the DNA in cancer cells, which stops them from dividing and growing. In this trial, it is being combined with other medications to see if it can improve treatment outcomes for patients.

Nivolumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used in the treatment of several types of cancer. In this study, it is being tested to see if it can enhance the effectiveness of chemotherapy in patients with advanced stomach and esophageal cancers.

FOLFOX is a combination chemotherapy regimen that includes several drugs used to treat cancer. It typically consists of folinic acid, fluorouracil, and oxaliplatin. This regimen is being compared to other treatments in the trial to determine which is more effective in managing advanced stomach and esophageal cancers.

Investigated diseases:

Gastric Adenocarcinoma – This is a type of cancer that begins in the glandular cells of the stomach lining. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can cause symptoms like stomach pain, nausea, and weight loss. The disease can spread to nearby organs and lymph nodes. It is classified as locally advanced, recurrent, or metastatic based on its spread and recurrence.

Esophageal Adenocarcinoma – This cancer starts in the mucus-secreting glands of the esophagus, typically in the lower part. It progresses by invading deeper layers of the esophagus and can spread to nearby tissues and lymph nodes. Symptoms may include difficulty swallowing, chest pain, and weight loss. The disease can be locally advanced, recurrent, or metastatic, indicating its extent and recurrence.

Gastroesophageal Junction Adenocarcinoma – This cancer occurs where the esophagus meets the stomach. It progresses by growing into surrounding tissues and can spread to lymph nodes and distant organs. Symptoms often include difficulty swallowing, heartburn, and weight loss. The disease is categorized as locally advanced, recurrent, or metastatic, reflecting its spread and recurrence.

Trial ID:

2024-512999-35-00

Protocol code:

UC-GIG-2023

NCT ID:

NCT05476796

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Oxaliplatin, Nivolumab, and Trifluridine/Tipiracil for Patients with Advanced Gastric, Esophageal, or Gastroesophageal Junction Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?