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A randomized phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy

This phase II clinical trial is testing two different chemotherapy treatments for people with advanced pancreatic cancer that has spread to other areas of the body. It is designed for patients whose cancer has grown or returned after having an initial treatment known as gemcitabine. All participants will receive a medicine called liposomal irinotecan, given into a vein. Alongside this, one group will receive a standard chemotherapy drug called 5-fluorouracil (5-FU) through a drip. The other group will take an alternative medicine called S-1 (Teysuno) as capsules by mouth. Researchers want to see if one combination is better at keeping the cancer under control for longer. They will also look at overall survival, how tumours shrink, side effects, and how each treatment affects daily quality of life. This helps doctors decide the best second-step treatment option for future patients.

At a glance

Status
Recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Amsterdam UMC
Enrolment target
146
Start
12 Dec 2024
metastatic pancreatic cancer

What is this study about?

Pancreatic cancer starts in the pancreas, an organ in the tummy that aids digestion and controls blood sugar. In many cases, the cancer is diagnosed after it has spread to other parts of the body, which doctors call metastatic cancer. Standard first treatments often use a chemotherapy medicine called gemcitabine. However, over time, the cancer can become resistant to this medicine and start growing again, meaning doctors need effective next-step options.

This clinical study focuses on what doctors call 'second-line' treatment. It compares two combinations of chemotherapy to see which one works better when first-line gemcitabine has stopped working. Both groups receive a drug called liposomal irinotecan (Onivyde), which is packaged in tiny fat bubbles to help deliver the medicine directly into cancer cells.

The study compares giving liposomal irinotecan with 5-fluorouracil (5-FU), which is given through a drip, against giving it with S-1 (Teysuno), which comes as capsules you swallow. The goal is to see if one combination keeps the cancer from growing for longer. Researchers will also closely monitor tumour size, how long patients live, any side effects, and overall quality of life.

Finding better second-line treatments is crucial for people with advanced pancreatic cancer. If one of these combinations proves to be more effective or easier to tolerate, it could help guide NHS treatment choices and give patients more precious, comfortable time.

Key takeaways

  • Tests two chemotherapy combinations for advanced pancreatic cancer that has spread.
  • Aimed at adults whose cancer has worsened after previous gemcitabine treatment.
  • Compares an oral capsule treatment (S-1) with a drip treatment (5-FU), both combined with liposomal irinotecan.
  • Aims to find out which treatment keeps cancer stable for longer and maintains quality of life.
  • Participation is entirely voluntary, and you can leave the study at any time.

Who may be eligible?

This trial is open to adults aged 18 and older who have been diagnosed with advanced (metastatic) pancreatic cancer that has spread beyond the pancreas. To be considered, you must have already received a first-line chemotherapy based on gemcitabine that is no longer controlling the cancer.

Because chemotherapy can place stress on the body, participants must be generally well enough to care for themselves and handle daily activities. Your kidneys, liver, and bone marrow also need to be working well enough to process the trial medicines safely, which will be confirmed through standard blood tests.

You may not be eligible if you have serious other medical conditions, severe infections, or unresolved side effects from past treatments. The hospital trial team will review your full medical records and carry out routine health checks before confirming if you can join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am aged 18 or older.
  2. I have been diagnosed with pancreatic cancer that has spread (metastatic).
  3. I have already received gemcitabine-based chemotherapy, and the cancer has started growing again.
  4. I am well enough to look after myself and do light daily tasks.
  5. I am willing to attend regular hospital appointments for check-ups, scans, and blood tests.
Answer every question to see your result.

What does participation involve?

Taking part involves regular visits to the hospital clinic. Because this is a randomised study, a computer will allocate you by chance to one of two treatment groups. Both groups receive liposomal irinotecan through a drip into a vein (an intravenous infusion). One group also receives 5-fluorouracil through an infusion pump, while the other group takes S-1 capsules by mouth at home.

You will have regular clinic visits for physical exams, blood tests, and scans (such as CT scans) every few weeks to check your tumour and monitor your general health. You will also be asked to fill in simple questionnaires about your symptoms and daily well-being. Treatment usually continues for as long as it is helping and side effects remain manageable, followed by routine follow-up visits to check on your recovery and health.

Potential risks and benefits

The possible benefit is that the study treatment may help shrink or slow down the growth of the cancer, although this cannot be guaranteed for every person. The main risks are the side effects associated with chemotherapy, which can include tiredness, sickness, diarrhoea, mouth ulcers, hair thinning, and a lowered immune system leading to a higher risk of infections. Your care team will monitor you very closely and provide supportive medicines to help manage any discomfort. Joining the study is completely voluntary, and you have the right to withdraw at any time without your regular NHS care being affected.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Spain
  • —
    Unverified
    Italy
  • —
    Unverified
    Netherlands
  • —
    Unverified
    Austria

Common questions

What is a phase II clinical trial?

A phase II trial tests how well a treatment works against a specific condition and looks closely at side effects in a medium-sized group of patients.

Can I choose which treatment group I join?

No. A computer places participants into groups by chance (randomisation). This ensures the comparison between the two treatments is fair and unbiased.

Do I have to pay for the trial medicines?

No, the study medicines and trial-related tests are provided free of charge, usually through the hospital research department.

Will taking capsules instead of a drip change how often I visit the clinic?

Taking capsules at home may reduce the time spent having drips at the hospital, but you will still need regular clinic appointments for safety checks and scans.

What happens if my cancer gets worse during the study?

Your doctor will stop the trial treatment immediately and discuss the best available alternative care and symptom relief options with you.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A randomized phase II study of second line treatment with li…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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