Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

14 criteria

  • 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 trial?

10 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

  • Trifluridine/Tipiracil

    This medication is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating certain types of advanced gastric and esophageal cancers. It is primarily indicated for patients with HER2 negative locally advanced, recurrent, or metastatic gastric, esophageal, or gastroesophageal junction adenocarcinoma. The drug works by incorporating into DNA and inhibiting cell division, thereby slowing the growth of cancer cells. It is classified as an antineoplastic agent.

  • Oxaliplatin

    Administered intravenously, oxaliplatin is a chemotherapy drug used in combination with other medications to treat advanced gastric and esophageal cancers. It is being evaluated in clinical trials for its potential to improve progression-free survival in patients with HER2 negative locally advanced, recurrent, or metastatic gastric, esophageal, or gastroesophageal junction adenocarcinoma. Oxaliplatin works by forming cross-links in DNA, which prevents cancer cells from dividing and growing. It belongs to the class of platinum-based antineoplastic agents.

  • Nivolumab

    This medication is given as an intravenous infusion and is currently under investigation in clinical trials for its role in treating advanced gastric and esophageal cancers. It is used for patients with HER2 negative locally advanced, recurrent, or metastatic gastric, esophageal, or gastroesophageal junction adenocarcinoma. Nivolumab is an immune checkpoint inhibitor that enhances the body's immune response against cancer cells by blocking the PD-1 pathway. It is classified as an immunotherapy drug.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512999-35-00Protocol codeUC-GIG-2023Estimated enrolment118 patientsSponsorUnicancer

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.