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Study Comparing Ramucirumab with Irinotecan, Leucovorin, and 5-FU or Paclitaxel for Patients with Advanced Stomach or Gastroesophageal Cancer After Previous Chemotherapy

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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 or metastatic adenocarcinoma of the stomach or gastroesophageal junction. These are types of cancer that occur in the stomach or the area where the stomach meets the esophagus. The study is comparing two different treatment combinations. One group of patients will receive a combination of ramucirumab with irinotecan, leucovorin, and 5-FU (also known as FOLFIRI). The other group will receive ramucirumab with paclitaxel. The purpose of the study is to see which treatment is more effective in improving the overall survival of patients who have not responded to previous chemotherapy treatments.

Participants in the study will be randomly assigned to one of the two treatment groups. The treatments will be given through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will last for a period of up to 12 months, during which time patients will receive regular treatments and be monitored for any changes in their condition. The study will also include a group of patients who will receive a placebo, which is a substance with no active medication, to compare the effects of the treatments.

The trial aims to provide valuable information on the effectiveness of these treatment combinations in managing advanced stomach cancer. By comparing the two groups, researchers hope to determine which combination offers better outcomes in terms of survival and response to treatment. This study is important for developing new strategies to treat patients with this type of cancer, especially those who have not had success with previous therapies.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Eligibility criteria include having advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction and having previously received chemotherapy.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups. This process ensures that each participant has an equal chance of receiving either treatment option.

  3. Step 3

    Treatment group 1: ramucirumab with FOLFIRI

    Participants in this group receive a combination of ramucirumab and FOLFIRI. FOLFIRI includes irinotecan hydrochloride trihydrate, calcium folinate, and fluorouracil.

    Ramucirumab is administered as a solution for infusion. Irinotecan and calcium folinate are also given as solutions for infusion, while fluorouracil is provided as an injection or infusion.

    The treatment is administered intravenously, meaning it is delivered directly into the bloodstream through a vein.

  4. Step 4

    Treatment group 2: ramucirumab with paclitaxel

    Participants in this group receive a combination of ramucirumab and paclitaxel.

    Both medications are administered as solutions for infusion, delivered intravenously.

    The treatment schedule and dosage are determined by the study protocol and are designed to optimize effectiveness while minimizing side effects.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, participants undergo regular monitoring to assess the effectiveness of the treatment and to manage any side effects.

    This includes routine blood tests, imaging studies, and clinical evaluations to track the progress of the disease and the participant's overall health.

  6. Step 6

    Completion of study

    The study is expected to conclude by October 31, 2025. At the end of the study, final assessments are conducted to evaluate the outcomes of the treatments.

    Participants may be asked to attend follow-up visits to monitor long-term effects and overall survival.

Who can join the trial?

10 criteria

  • Must sign a written informed consent form, which is a document that explains the study and confirms your agreement to participate.
  • Must be male or female and at least 18 years old. If you can have children, you need to agree to use reliable birth control during the study and for 3 months after the treatment ends. Women who can have children must have a negative pregnancy test before starting the study.
  • Must have a confirmed diagnosis of gastric adenocarcinoma, which is a type of cancer in the stomach or the area where the stomach meets the esophagus.
  • Must have cancer that has spread (metastatic) or is advanced and cannot be removed by surgery.
  • For Phase II: Must show disease progression, meaning the cancer has gotten worse, during or within 6 months after the last dose of a specific type of chemotherapy. For Phase III: Must show disease progression during or after the last dose of a specific type of chemotherapy and have received a taxane, which is a type of chemotherapy drug.
  • Must have disease that can be measured or evaluated by doctors.
  • Must have an ECOG performance status of 0-1, which means you are fully active or have some symptoms but can still do light work.
  • Must have a life expectancy of more than 12 weeks.
  • Must have adequate blood, liver, and kidney function, which means your body is working well enough to handle the treatment. This includes specific blood counts and levels of substances in your blood that doctors will check.
  • Must be able to attend scheduled assessments and manage any side effects from the treatment.

Who cannot join the trial?

3 criteria

  • Patients who have not failed a previous treatment that included a type of drug called **Taxane** cannot participate. **Taxane** is a type of chemotherapy drug used to treat cancer.
  • Patients with a type of cancer that is not **advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junctions** cannot participate. **Adenocarcinoma** is a type of cancer that forms in mucus-secreting glands, and **metastatic** means the cancer has spread to other parts of the body.
  • Patients who have not received a prior line of **palliative chemotherapy** cannot participate. **Palliative chemotherapy** is treatment given to relieve symptoms and improve quality of life, but not to cure the disease.
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Investigated drugs

  • Ramucirumab

    is a medication used in this trial to treat patients with advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. It is combined with other chemotherapy drugs to help slow down the growth of cancer cells.

  • Irinotecan

    is a chemotherapy drug used in this trial. It works by interfering with the DNA of cancer cells, preventing them from dividing and growing. It is part of a combination treatment to enhance its effectiveness against cancer.

  • Leucovorin

    is used in this trial to enhance the effects of other chemotherapy drugs. It helps protect healthy cells from the harmful effects of chemotherapy and improves the overall treatment outcome.

  • 5-FU (5-Fluorouracil)

    is a chemotherapy medication used in this trial. It works by blocking the growth of cancer cells, which helps to slow down or stop the spread of cancer.

  • Paclitaxel

    is another chemotherapy drug used in this trial. It helps stop cancer cells from dividing and growing, which can help control the spread of cancer. It is used in combination with ramucirumab to improve treatment results.

What is already known about the treatment

  • Ramucirumab

    This medication is administered intravenously and is used in combination with other drugs for treating advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction, particularly in patients who have not responded to previous chemotherapy. It is currently being studied in clinical trials to assess its effectiveness in improving overall survival and response rates. Ramucirumab works by blocking a specific protein involved in the growth of blood vessels that supply tumors, thereby inhibiting tumor growth. It is classified as a monoclonal antibody and is part of targeted cancer therapies.

  • Irinotecan

    Administered intravenously, this medication is used in combination with other drugs to treat advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. It is being evaluated in clinical trials for its effectiveness in combination therapies. Irinotecan works by interfering with the DNA replication process in cancer cells, leading to cell death. It is classified as a topoisomerase inhibitor, which is a type of chemotherapy.

  • Leucovorin

    This medication is given intravenously and is used alongside other drugs to enhance their effectiveness in treating advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. It is part of ongoing clinical trials to determine its role in combination therapies. Leucovorin acts by stabilizing the binding of chemotherapy drugs to cancer cells, increasing their efficacy. It is classified as a chemoprotective agent.

  • 5-FU (Fluorouracil)

    Administered intravenously, this medication is used in combination with other drugs for treating advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. It is under investigation in clinical trials to evaluate its effectiveness in combination therapies. 5-FU works by disrupting the synthesis of DNA in cancer cells, preventing their growth and division. It is classified as an antimetabolite, a type of chemotherapy.

  • Paclitaxel

    This medication is administered intravenously and is used in combination with other drugs for treating advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. It is being studied in clinical trials to assess its effectiveness in combination therapies. Paclitaxel works by stabilizing the structure of microtubules in cancer cells, preventing them from dividing. It is classified as a taxane, a type of chemotherapy.

Investigated diseases

  • Adenocarcinoma of the Stomach

    This is a type of cancer that begins in the glandular cells of the stomach lining. It often develops slowly over many years and may not cause symptoms in the early stages. As it progresses, it can lead to symptoms such as stomach pain, nausea, and weight loss. The cancer can spread to nearby organs and lymph nodes, making it more challenging to treat. Advanced stages may involve the cancer spreading to distant parts of the body. It is often diagnosed at a later stage due to the subtlety of early symptoms.

  • Adenocarcinoma of the Gastroesophageal Junction

    This cancer occurs where the esophagus meets the stomach, affecting the glandular cells in this area. It can develop due to chronic acid reflux or other conditions that cause changes in the cells lining the esophagus. As the disease progresses, it may cause difficulty swallowing, chest pain, and unintended weight loss. The cancer can invade nearby tissues and spread to distant organs. It is often detected in advanced stages due to the non-specific nature of early symptoms. The progression can vary, but it typically involves increasing difficulty in swallowing and other digestive issues.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512934-14-00Protocol codeRAMIRISEstimated enrolment319 patientsSponsorFrankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

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