A study to determine whether the number and types of bacteria in the gut affects how well treatment works for bile duct cancer (ABC-12)
Cancer type:
Status:
Phase:
This study is looking at whether the number and types of bacteria that live naturally in our bowel affects how well the treatment for biliary cancer works.
It is for people with bile duct cancer that:
- cannot be removed by surgery and you haven’t had any treatment for it
- when you were first diagnosed the cancer had spread to another part of the body
- has come back at least 6 months after treatment with the aim to cure
It is also open to people with gallbladder cancer that has spread or come back least 6 months after treatment with the aim to cure.
More about this trial
In your mouth, gut and bowel (
) there are bacteria that normally live there. This is called the . Each person has an individual microbiome and it varies greatly form one person to the other. The function of the microbiome includes:
- the breakdown of food
- changing food into energy for the body
- protecting us against infection
It also helps in developing the .
There are lots of bacteria that make up the microbiome. Research shows that losing some of them can cause disease including cancer.
Durvalumab is an . It works by helping the immune system recognise and attack the cancer cells. Doctors already use durvalumab for other types of cancer.
Gemcitabine and cisplatin is one of the for bile duct cancer. Research shows that durvalumab with gemcitabine and cisplatin could help people with bile duct cancer. And soon doctors will also be able to use durvalumab with gemcitabine and cisplatin as a standard treatment where surgery is not possible.
In this study everyone will have durvalumab with gemcitabine and cisplatin.
The aims of this study are to find out:
- more about the microbiome
- whether the number and types of bacteria there are affects how well treatment works
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if all of the following apply. You:
- have an adenocarcinoma bile duct cancer or gallbladder cancer that has spread or has come back after having surgery only with the aim to cure. You can join if you had surgery followed by chemotherapy, radiotherapy or both with the aim to cure as long as the cancer came back more than 6 months after finishing treatment.
- have not had treatment for the cancer that has spread or come back
- have at least 1 area of cancer that the doctor can measure
- have a sample of cancer tissue the team can access
- are willing to give a poo sample and a spit (saliva) sample before starting treatment
- are up and about and can look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
- have satisfactory blood test results
- are willing to use reliable contraception during treatment and for a time after if there is any chance you or your partner could become pregnant
- weigh more than 30kg (4st 7lb)
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
- have ampullary cancer or bile duct cancer that is mixed with liver cancer
- have cancer that has spread to the brain or the tissues surrounding the brain
- have cancer pressing on the spinal cord (
spinal cord compression ) - have had treatment directly to the area of cancer in the bile duct such as
radioembolisation - are having radiotherapy to the area of cancer the doctor wants to measure
- have had an
immunotherapy apart from a cancer vaccine - have another cancer. This is apart from successfully treated
non melanoma skin cancer , a type of melanoma skin cancer called lentigo maligna or a carcinoma in situ . You could join if you had a cancer 5 or more years ago, as long as it was treated with the aim to cure and there has not been any sign of it since.
Medical conditions
You cannot join this study if any of these apply. You have:
- an
autoimmune disease apart from certain ones such as vitiligo and hair loss. Your doctor will know about this. - both hepatitis B and hepatitis C or you have hepatitis D
heart problems , lung problems , digestive system problems , any other medical conditions or mental health problems that could affect you taking part. Your doctor will know which ones these are.- an
immune system that isn’t working very well or you are taking medication that affects how well your immune system works - HIV
- ongoing side effects from previous treatment that are moderate to severe. This is apart from hair loss, vitiligo and changes to your blood test results.
- major surgery within 28 days of starting study treatment. For minor surgery for symptom relief it is 14 days.
- had previous immunotherapy treatment
- taken an experimental drug within the past 3 months
- taken durvalumab or another immunotherapy treatment as part of a clinical trial
Other
You cannot join this study if any of these apply. You:
- are allergic or sensitive to the treatments or any of their ingredients used in this study
- have a
live vaccine within 30 days of starting the study treatment. You should not have a live vaccine while having treatment and for a further 30 days after finishing treatment. The COVID-19 and seasonal flu vaccines are not live vaccines. - are pregnant or breastfeeding
Trial design
The team need 70 people to take part.
You have durvalumab followed by cisplatin and gemcitabine every 3 weeks. Each 3 week period is a . You have 8 cycles of this.
After the 8 cycles you have durvalumab on its own every 4 weeks. You continue to have durvalumab as long as it is helping and the side effects aren’t too bad.
You have all the treatment as a drip into a vein.
Samples for research
You give poo samples and spit (saliva) samples when you start treatment. And then at 18 weeks of treatment or earlier if your cancer starts to get worse before the 18 weeks.
Hospital visits
You see the doctor to have a and tests. These include:
- blood tests
- a urine test
- a heart trace (ECG) if your doctor thinks you need on
- a CT scan or an MRI scan
You see the doctor every 6 weeks during treatment. This is to see how you are and for blood tests.
You have a scan every 6 weeks for 24 weeks and then every 8 weeks until your cancer starts to grow again.
After treatment you see the doctor every 8 weeks. If you stopped treatment because your cancer got worse, you see the doctor when you finish treatment. And then a member of the study team will phone you every 4 weeks, if appropriate, to see how you are and if you have started any more treatment.
Side effects
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
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Durvalumab can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
We have information about:
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Mairéad McNamara
Supported by
AstraZeneca
The Christie NHS Foundation Trust
Cardiff University Centre for Trials Research
The University of Manchester
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
