RecruitingPHASE2INTERVENTIONAL

Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma

This research study is investigating a new treatment approach for extrahepatic cholangiocarcinoma, a type of bile duct cancer that affects ducts outside the liver and cannot be removed by surgery. The study combines a local heating treatment called intraductal radiofrequency ablation (ID-RFA), which helps clear the bile ducts, with standard chemotherapy (Gemcitabine and Cisplatin) and a new immunotherapy drug called Durvalumab. Researchers want to see if adding RFA to the chemotherapy and Durvalumab might be more effective at fighting the cancer than current treatments. This trial is in its second phase, meaning it's still an early study, and will involve patients who have already had RFA and stenting to relieve bile duct blockages. The goal is to improve anti-cancer activity for these patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrolment target

Start

23 Aug 2024

Estimated completion

01 Apr 2028

Extrahepatic Cholangiocarcinoma Unresectable Perihilar or Ductal CCA

What is this study about?

This study is about an important type of cancer found in the bile ducts outside the liver, called extrahepatic cholangiocarcinoma. For some people, this cancer can't be completely removed with surgery. In these cases, doctors look for other ways to treat it and slow its growth.

This study will combine a few different treatments that are already used. First, there's a procedure called intraductal radiofrequency ablation, or ID-RFA. This uses heat directly inside the bile ducts to destroy cancer cells and help keep the ducts open. Patients taking part in this study will have already had this treatment and a stent placed to help with any blockages. After that, they will receive standard chemotherapy drugs called Gemcitabine and Cisplatin. On top of this, they'll also get a newer medicine called Durvalumab, which is a type of immunotherapy that helps your body's immune system fight cancer.

The main idea behind this research is to see if putting all these treatments together – ID-RFA, chemotherapy, and Durvalumab – works better at fighting the cancer than just using chemotherapy alone. Doctors are hoping this combination will be more powerful against the cancer cells. This is a Phase 2 study, which means it's an early stage of research to check if the treatment is safe and shows promising results in a group of patients.

Key takeaways

Targets bile duct cancer outside the liver that can't be surgically removed.
Combines local heat treatment (RFA) with chemotherapy and immunotherapy (Durvalumab).
Aims to improve cancer fighting ability for this specific patient group.
It's a Phase 2 study, meaning it's an early look at safety and effectiveness.
Patients will have already had RFA for bile duct blockages.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of extrahepatic cholangiocarcinoma that affects the bile ducts outside the liver and cannot be removed by surgery. Also, you must have already had an RFA procedure and a stent placed to help with any bile duct blockages, and these blockages should now be resolved.

Your medical team needs to agree that standard chemotherapy is suitable for you, and you should be healthy enough for it, apart from any temporary issues caused by bile duct blockages. Generally, you should be able to look after yourself with minimal help, have a life expectancy of at least 12 weeks, and weigh more than 30 kg (about 4 stone 10 pounds). Your blood tests for your blood count, liver, and kidney function also need to be within a certain healthy range.

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.

Are you at least 18 years old?
Do you have extrahepatic cholangiocarcinoma that can't be removed by surgery?
Have you already had RFA and a stent placed for bile duct blockages, and are they now clear?
Are you generally well enough for chemotherapy?
Do you have a life expectancy of at least 12 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given a combination of treatments. This includes specific chemotherapy drugs, Gemcitabine and Cisplatin, along with the drug Durvalumab. You will also be eligible for repeat RFA procedures during the study if your doctor decides it's needed.

Participation will involve regular hospital visits for treatments, check-ups, and tests to monitor your health and how you're responding to the treatment. This will include blood tests, scans, and physical examinations. The exact schedule will be explained by the study team, but it will continue for as long as the treatment is benefiting you and you are tolerating it well. Following study rules, attending all scheduled appointments, and undergoing specific examinations are important parts of your commitment.

Potential risks and benefits

Like all medical treatments, there are potential benefits and risks to consider. The potential benefit of joining this study is that the combination of treatments might be more effective at fighting your cancer than existing treatments. However, there's no guarantee it will work for everyone, and it might not improve your condition. All the medicines involved have potential side effects, which the study team will explain in detail. These can range from mild to serious, and some effects of combining these treatments might not be fully known yet. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (10)

Uniklinik RWTH Aachen
Verified postcode
Aachen, Germany· Recruiting
Universitätsklinikum Bonn
Verified postcode
Bonn, Germany· Recruiting
Universitätsklinikum Köln
Verified postcode
Cologne, Germany· Recruiting
Universitätsklinikum Düsseldorf
Verified postcode
Düsseldorf, Germany· Recruiting
Krankenhaus Nordwest
Verified postcode
Frankfurt, Germany· Recruiting
Universitätsmedizin Göttingen
Verified postcode
Göttingen, Germany· Recruiting
Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany· Recruiting
UKSH Campus Lübeck
Verified postcode
Lübeck, Germany· Recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Verified postcode
Mainz, Germany· Recruiting
Universitätsklinik Münster
Verified postcode
Münster, Germany· Not yet recruiting

Common questions

What is 'extrahepatic cholangiocarcinoma'?

It's a type of cancer that starts in the bile ducts outside the liver.

What does 'unresectable' mean?

It means the cancer can't be fully removed with surgery.

What is ID-RFA?

It's a treatment that uses heat inside the bile ducts to destroy cancer cells and clear blockages.

What is Durvalumab?

It's a type of immunotherapy that helps your body's immune system fight cancer.

Is this a new treatment?

This study combines existing treatments in a new way to see if they work better together.

How to find out more

Christoph Roderburg, Prof. Dr.

christoph.roderburg@med.uni-duesseldorf.de +49 211 8108030 Official trial record

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