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Prospective phase IIb study to evaluate the efficacy of laparoscopic electrochemotherapy in the treatment of locally advanced pancreatic cancer - ECT-LAPC Laparoscopic

Pancreatic cancer can be difficult to treat, especially when it has grown into nearby tissues and cannot be removed by an operation. This is called locally advanced pancreatic cancer. The usual treatment is chemotherapy to help slow down the tumour's growth. This trial is testing a technique called electrochemotherapy, performed through keyhole surgery. During the procedure, doctors give a chemotherapy drug and apply brief electrical pulses to the tumour. These pulses temporarily open tiny pores in cancer cells, allowing more medicine to enter and destroy them. Participants will either receive standard chemotherapy alone or standard chemotherapy combined with electrochemotherapy. Doctors want to see if this new approach shrinks tumours more effectively, relieves tummy or back pain, and improves quality of life. In some cases, shrinking the tumour might make it possible to remove the cancer with surgery in the future.

At a glance

Status
Recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Enrolment target
90
Start
02 Dec 2024

What is this study about?

Locally advanced pancreatic cancer means the tumour has grown around vital blood vessels near the pancreas. Because of this, surgeons cannot safely take it out straight away. Standard care relies on strong chemotherapy combinations to keep the cancer from spreading and to help manage symptoms. However, doctors are always looking for better ways to make these treatments more effective.

This study looks at a procedure called laparoscopic electrochemotherapy. 'Laparoscopic' means it is done using keyhole surgery, where a surgeon makes small cuts in the tummy and uses a tiny camera and instruments. During the operation, a chemotherapy medicine called bleomycin is given, followed by gentle, controlled electrical pulses directed at the tumour. These pulses make the cancer cell walls briefly porous, acting like an open door so the medicine can rush inside.

Researchers want to find out if adding electrochemotherapy to regular chemotherapy does a better job of shrinking the tumour than chemotherapy alone. They also want to see whether it reduces cancer-related pain, improves day-to-day wellbeing, and helps people live longer without their illness getting worse.

Another important goal is to see if electrochemotherapy can shrink the tumour enough to make future surgery an option. Taking part in this study could help doctors understand whether this combined approach offers a safe and powerful new option for people living with pancreatic cancer.

Key takeaways

  • Tests whether electrochemotherapy combined with standard chemotherapy improves pancreatic cancer care.
  • The procedure uses keyhole surgery to deliver brief electrical pulses to the tumour.
  • Aims to shrink tumours, relieve cancer-related pain, and extend quality of life.
  • Open to adults with locally advanced pancreatic cancer that cannot be removed by surgery.
  • Taking part is voluntary, and you can withdraw at any time.

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 an operation. Patients must be well enough to undergo both standard chemotherapy and a keyhole surgical procedure under general anaesthetic.

You may not be able to take part if your cancer has already spread to distant parts of your body, such as your liver or lungs, or if you have other serious health problems—such as severe heart or lung conditions—that would make surgery unsafe.

A doctor will carry out detailed scans and health checks to confirm whether this trial is a suitable and safe match 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.

  1. I am aged 18 or older.
  2. I have been diagnosed with locally advanced pancreatic cancer.
  3. My cancer cannot currently be removed by surgery.
  4. My cancer has not spread to distant parts of my body.
  5. I am well enough to have keyhole surgery and chemotherapy.
Answer every question to see your result.

What does participation involve?

If you take part, you will be placed into a treatment group to receive either standard chemotherapy on its own or standard chemotherapy alongside electrochemotherapy. Electrochemotherapy involves a short hospital stay for a keyhole surgical procedure performed under general anaesthetic. Chemotherapy medicines are given through a drip into a vein on regular scheduled cycles over several weeks or months. You will need to attend hospital for routine blood tests, health check-ups, and regular CT or MRI scans to monitor the tumour. You will also be asked to complete simple questionnaires about your pain levels and general quality of life. The study team will follow your progress closely throughout your treatment and for several months afterwards.

Potential risks and benefits

A potential benefit is that electrochemotherapy may shrink your tumour more effectively, which could help relieve cancer-related pain and potentially make future surgery possible. However, there is no guarantee that the treatment will work for everyone. Potential risks include the usual side effects of chemotherapy, such as tiredness, sickness, and a higher risk of infections, as well as temporary soreness, bruising, or complications from the keyhole operation. Taking part is completely voluntary, and you can withdraw from the study at any time without your regular NHS medical care being affected.

Locations (1)

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

Common questions

What is electrochemotherapy?

It is a treatment that uses short, controlled electrical pulses to open tiny pores in cancer cells, helping chemotherapy medicine get directly inside to destroy them.

Will I have to stay in hospital?

Yes, you will likely need a short stay in hospital for the keyhole procedure, while regular chemotherapy is usually given as a day patient.

Will the procedure be painful?

The keyhole surgery is performed under a general anaesthetic, so you will be asleep and feel nothing during the treatment. You will be given painkillers to help with any soreness afterwards.

Can I choose which treatment group I am in?

No, a computer randomly assigns participants to either standard chemotherapy alone or standard chemotherapy with electrochemotherapy, ensuring the study results are fair and reliable.

What happens if I change my mind about taking part?

You are free to leave the trial at any point. Your decision will not change your relationship with your medical team or the quality of your care.

How to find out more

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 "Prospective phase IIb study to evaluate the efficacy of lapa…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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