Not recruiting

Study of Irinotecan with S1 or 5-Fluorouracil for Patients with Metastatic Pancreatic Cancer After Gemcitabine Treatment

Verified siteRegistered drugNo placebo

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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 metastatic pancreatic cancer, a type of cancer that has spread from the pancreas to other parts of the body. The study is exploring the effectiveness of two different treatment combinations for patients whose cancer did not respond to initial chemotherapy with a drug called gemcitabine. The first treatment combination includes liposomal irinotecan and a medication known as S-1, which is a combination of three substances: tegafur, gimeracil, and oteracil. The second treatment combination involves liposomal irinotecan and 5-fluorouracil, also known as 5-FU, which is often used in cancer treatment.

The purpose of this study is to determine which treatment combination is more effective in delaying the progression of the cancer. Participants in the study will receive one of the two treatment combinations. The treatments are administered through intravenous infusion, which means they are given directly into a vein, or in the case of S-1, taken orally as capsules. The study will monitor the participants over a period to see how the cancer responds to the treatments and to assess any side effects or changes in quality of life.

Throughout the study, researchers will focus on measuring how long the cancer can be kept from getting worse, known as progression-free survival. They will also look at overall survival rates, how well the cancer responds to the treatments, any side effects experienced, and the impact on the participants' quality of life. This information will help determine the best treatment option for patients with metastatic pancreatic cancer who have not had success with gemcitabine-based chemotherapy.

The research process

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

Step 1
Joining the study
Upon joining the study, you will be asked to provide written consent, confirming your understanding and agreement to participate.
You must be at least 18 years old and have a confirmed diagnosis of metastatic pancreatic cancer.
Your previous treatment should have included gemcitabine-based chemotherapy.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your health status.
This includes checking liver, kidney, and blood functions to ensure they meet the required levels.
Step 3
Treatment assignment
You will be randomly assigned to one of two treatment groups.
One group will receive liposomal irinotecan and S-1, while the other group will receive liposomal irinotecan and 5-fluorouracil.
Step 4
Treatment administration
If you are in the liposomal irinotecan and S-1 group, you will receive liposomal irinotecan through an intravenous infusion and take S-1 capsules orally.
If you are in the liposomal irinotecan and 5-fluorouracil group, you will receive both medications through intravenous infusions.
Step 5
Monitoring and follow-up
Regular monitoring will be conducted to assess your response to the treatment.
This includes evaluating progression-free survival, overall survival, and any side effects experienced.
Step 6
Completion of the study
The study is expected to continue until November 2031.
Upon completion, your overall health and response to the treatment will be reviewed.

Who can join the trial?

12 criteria

Able to understand and provide written informed consent.
Must be 18 years of age or older.
Must have a confirmed diagnosis of pancreatic cancer through a test called histology or cytology.
Must have cancer that has spread to other parts of the body, as documented by a specific set of guidelines called RECIST 1.1.
Must have been previously treated with a chemotherapy drug called gemcitabine, or the cancer must have worsened within 6 months after receiving gemcitabine as part of a treatment plan.
Must have adequate liver function, which means certain blood tests should be within specific ranges:
- Total bilirubin: 0-17 µmol/L
- AST (a liver enzyme): 0-40 U/L
- ALT (another liver enzyme): 0-34 U/L
- Must have adequate kidney function, with creatinine levels between 65-95 µmol/L.
- Must have adequate blood health, with the following levels:
  - Hemoglobin: 7.5-10 mmol/L
  - Platelets: 150-400 x 10⁹/L
  - Leukocytes (white blood cells): 4.0-10.5 x 10⁹/L

Who cannot join the trial?

3 criteria

Patients who have not been treated with gemcitabine-based chemotherapy for their **metastatic pancreatic cancer**.
Patients who have not experienced cancer progression within 6 months after completing **adjuvant gemcitabine treatment**. Adjuvant treatment is additional cancer treatment given after the primary treatment to lower the risk of the cancer coming back.
Patients who are part of a **vulnerable population**. This means groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those unable to give consent.

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Verified sites

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

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Centro Ricerche Cliniche Di Verona S.r.l.
Verified
Verona, Italy
Hospital Vall d’Hebron
Verified
Barcelona, Spain

Trial locations

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Investigated drugs

Liposomal Irinotecan
is a form of chemotherapy used to treat cancer. It is designed to deliver the active drug, irinotecan, directly to the cancer cells in a more targeted way. This helps to reduce the side effects that are often associated with chemotherapy. In this trial, liposomal irinotecan is being used to treat patients with pancreatic cancer who have not responded to previous treatments.
S-1
is an oral medication used in cancer treatment. It combines three different components that work together to stop cancer cells from growing and multiplying. S-1 is often used in combination with other cancer drugs to improve its effectiveness. In this study, it is being tested alongside liposomal irinotecan to see if it can help control pancreatic cancer.
5-Fluorouracil (5-FU)
is a type of chemotherapy that works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is a well-known treatment for various types of cancer and is often used in combination with other drugs to enhance its effects. In this trial, 5-FU is being used with liposomal irinotecan to evaluate its effectiveness in treating pancreatic cancer.
Leucovorin (LV)
is not a chemotherapy drug itself, but it is often used in combination with chemotherapy to enhance its effects. It helps to protect healthy cells from the damage caused by chemotherapy drugs like 5-fluorouracil. In this study, leucovorin is used alongside 5-FU and liposomal irinotecan to help improve the treatment outcomes for patients with pancreatic cancer.

What is already known about the treatment

Liposomal Irinotecan
Liposomal Irinotecan is administered intravenously, meaning it is given through a vein, usually in a hospital or clinic setting. It is currently being studied in clinical trials for its effectiveness in treating metastatic pancreatic cancer, particularly in patients who have not responded to initial gemcitabine-based chemotherapy. The medication works by interfering with the DNA of cancer cells, preventing them from multiplying and spreading. It belongs to a class of drugs known as topoisomerase inhibitors, which are used to treat various types of cancer by targeting the enzymes involved in DNA replication.
S-1
S-1 is an oral medication, meaning it is taken by mouth in the form of a pill. It is being investigated in clinical trials for its potential to treat metastatic pancreatic cancer, especially in patients who have not had success with gemcitabine-based chemotherapy. S-1 works by inhibiting the growth of cancer cells through a combination of compounds that block the synthesis of DNA and RNA, essential components for cell division. It is classified as an antimetabolite, a type of drug that interferes with the normal metabolism of cancer cells, thereby slowing or stopping their growth.
5-Fluorouracil (5-FU)
5-Fluorouracil is administered intravenously, typically in a clinical setting, and is being studied for its use in treating metastatic pancreatic cancer in patients who have not responded to gemcitabine-based treatments. This medication works by disrupting the production of DNA in cancer cells, which prevents them from growing and dividing. It is part of the antimetabolite class of drugs, which are designed to interfere with the metabolic processes of cancer cells, ultimately leading to their death.

Investigated diseases

Metastatic Pancreatic Cancer – Metastatic pancreatic cancer is a type of cancer that originates in the pancreas and has spread to other parts of the body. The disease begins in the pancreatic ductal cells, which are responsible for producing digestive enzymes. As the cancer progresses, it invades nearby tissues and organs, such as the liver, lungs, or peritoneum. The spread of cancer cells occurs through the bloodstream or lymphatic system. Symptoms may include abdominal pain, weight loss, jaundice, and changes in stool. The progression of the disease can lead to further complications as it affects more organs.