AuthorisedPhase II and Phase III (Integrated)Interventional

A Prospective, Randomized, Controlled, Multinational, Phase 2/3, Open-Label Trial to Evaluate the Efficacy and Safety of SIL204-SL Administered as an Integrated Therapeutic Regimen in Combination with Chemotherapy vs. Chemotherapy Treatment Alone in Participants with Locally Advanced Pancreatic Cancer

This clinical trial is testing whether a new study drug called SIL204-SL can improve treatment for adults with locally advanced pancreatic cancer that cannot be removed with an operation. Participants are divided into groups: one group receives standard NHS-type chemotherapy alone, while the other receives chemotherapy plus the new treatment. Doctors want to see if adding SIL204-SL helps people live longer and stops the cancer from growing for longer. They will also closely monitor safety, side effects, and daily quality of life, including pain levels and energy. To take part, your tumour will also be checked for specific gene changes called KRAS mutations. The study lasts for up to two years of regular monitoring.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Silexion Therapeutics Ltd.

Enrolment target

Start

23 Jun 2026

Non-Resectable Locally Advanced Pancreatic Cancer (LAPC)

What is this study about?

Pancreatic cancer can be difficult to treat, especially when it has grown into nearby blood vessels or tissues and cannot be safely removed with surgery. In the UK, standard care for this stage of cancer usually involves chemotherapy to control the tumour and ease symptoms. However, doctors are actively searching for new treatments that can work alongside chemotherapy to make it more effective.

This trial is testing an experimental medicine called SIL204-SL. Researchers are studying whether giving this new medicine alongside standard chemotherapy helps shrink tumours more effectively and keeps the cancer from growing back. They are particularly interested in seeing how the treatment works in tumours with specific common genetic changes, known as KRAS mutations.

Participants will be placed into treatment groups to compare standard chemotherapy alone against chemotherapy combined with SIL204-SL. Over the course of up to two years, doctors will carefully track how long patients live, how their tumours respond on scans, and how well the treatment is tolerated.

Importantly, the study also focuses on how participants feel day-to-day. You will be asked about pain, daily activities, and general wellbeing. This helps researchers understand whether the new treatment not only helps people live longer, but also supports a good quality of life during and after treatment.

Key takeaways

Tests whether adding the study drug SIL204-SL to standard chemotherapy improves survival in pancreatic cancer.
For adults with locally advanced pancreatic cancer that cannot be removed by surgery.
Tumours will be checked for specific KRAS gene changes before or during the study.
Participants are randomly assigned to receive either chemotherapy alone or chemotherapy with the new drug.
Health, side effects, and quality of life are closely tracked for up to 24 months.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with locally advanced pancreatic cancer that cannot be removed by surgery (often called non-resectable cancer). It is designed for people whose cancer has not spread to distant parts of the body, such as the liver or lungs.

Because the study focuses on how certain tumours respond, your care team will test a sample of your tumour for specific gene markers called KRAS mutations (specifically G12D or G12V). You must also be well enough to safely receive regular chemotherapy.

You may not be eligible if your cancer can already be removed by surgery, if it has spread to distant organs, or if you have other serious medical conditions that would make taking part unsafe. Your hospital doctor will review your full medical history and recent scans to confirm whether the study is suitable for you.

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.

I am aged 18 or older.
I have been diagnosed with locally advanced pancreatic cancer.
My medical team has confirmed my tumour cannot be removed by surgery.
My cancer has not spread to distant parts of my body.
I am well enough to undergo regular chemotherapy treatments.

Answer every question to see your result.

What does participation involve?

Taking part involves regular visits to a specialist hospital cancer clinic over a period of up to 24 months. If you join, you will be placed into a group by chance (randomised). You will either receive standard chemotherapy on its own, or standard chemotherapy combined with the study drug, SIL204-SL.

Visits will involve having your chemotherapy and study medicine, routine blood tests, physical checks, and regular CT scans every few weeks to monitor your tumour. You will also be asked to complete short questionnaires about your pain levels, symptoms, and daily wellbeing. The study team will follow your health closely throughout treatment and for up to two years afterwards.

Potential risks and benefits

A potential benefit is that the study treatment may help shrink or control your cancer better than standard chemotherapy alone, though this cannot be guaranteed. The study also offers very close monitoring by cancer specialists. However, there are risks, including unknown side effects from the new drug as well as the usual side effects of chemotherapy, such as fatigue, sickness, or an increased risk of infection. Taking part is completely voluntary, and you are free to leave the trial at any point without it affecting your standard NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is SIL204-SL?

SIL204-SL is an experimental medicine being tested to see if it can boost the effects of standard chemotherapy against pancreatic cancer cells.

Can I choose which treatment group I am in?

No. A computer assigns you to a group at random. This ensures the trial results are completely fair and scientifically reliable.

Will I still receive standard cancer treatment?

Yes. Everyone in the study receives standard chemotherapy. Nobody receives a dummy drug (placebo) instead of active cancer treatment.

What is a KRAS mutation?

KRAS is a gene commonly altered in pancreatic cancer. Testing your tumour helps doctors see if this specific drug is well-matched to your type of cancer.

What happens if I change my mind?

You can leave the study at any time. Your medical team will simply continue treating you with the best available standard options.