A study of Acelarin with cisplatin for cancer of the bile duct or gallbladder (ABC-08)

Cancer type:

Bile duct cancer
Biliary tree cancers
Gallbladder cancer
Secondary cancers




Phase 1

This study looked at Acelarin and cisplatin chemotherapy for cancer of the bile duct, ampulla of Vater or gallbladder. 

It was for people whose cancer had grown into surrounding tissues, spread to another part of the body or come back after treatment. This is called advanced cancer. 

It was open for people to join between 2016 and 2018. The team published the results in 2021.

More about this trial

Bile duct cancer, ampulla of Vater cancer and gallbladder cancer are known as biliary tract cancers. The ampulla of Vater is where the pancreatic duct Open a glossary item meets the bile duct Open a glossary item.

At the time of this study, gemcitabine and cisplatin were a standard first treatment for advanced biliary tract cancer. Sometimes gemcitabine stops working. This is because cancer cells become resistant to it.

So researchers were looking for ways to improve treatment. In this study, doctors looked at the combination of Acelarin chemotherapy and cisplatin.

Acelarin (NUC-1031) is a similar drug to gemcitabine. But researchers have made changes to it to try to stop the cancer building up a resistance to the drug.

The main aims of this study were to:

  • find the best dose of Acelarin to have with cisplatin
  • learn more about the side effects of treatment 

Summary of results

Study design
This study was for people whose biliary tract cancer had come back after treatment or spread. And who hadn’t yet had chemotherapy to treat this. 

Everyone taking part had Acelarin (NUC-1031) and cisplatin. It was the first time people had this combination of treatment for biliary tract cancer. 

21 people took part. The first few people had a lower dose of Acelarin. The next few people had a higher dose if they didn’t have any bad side effects. And so on, until the research team found the best dose to give with cisplatin. This type of trial is called a dose escalation study.

The team found the best dose of Acelarin to have with cisplatin.

Everyone had treatment for as long as it was working and the side effects weren’t too bad. 

Side effects 
Everyone taking part had at least one side effect. Many were mild or didn’t last long. Some had more severe side effects. Researchers can class a side effect as serious for a number of reasons, including if:

  • the person has to go to hospital because of it
  • it is particularly important for the specific treatment in the trial

The most common severe side effects of Acelarin and cisplatin included: 

  • liver blood test changes
  • a drop in the number of blood cells that fight infection
  • feeling sick
  • diarrhoea 
  • tiredness (fatigue)
  • a build up of bilirubin Open a glossary item in the blood
  • a drop in the number of blood cells that clot the blood
  • blood clots 

The study team found the best dose and schedule of Acelarin and cisplatin to give. They concluded that the combination of treatment was safe. 

At the time of the publication of the results, researchers were doing a larger trial. They were looking at the combination of Acelarin and cisplatin for people with advanced bile duct, ampulla of Vater cancer or gallbladder cancer. 

More detailed information
There is more information about this research in the reference below. 

Please note, this article is not in plain English. It has been written for healthcare professionals and researchers.

A Phase Ib Study of NUC-1031 in Combination with Cisplatin for the First-Line Treatment of Patients with Advanced Biliary Tract Cancer (ABC-08)
M McNamara and others 
The Oncologist, 2021. Volume 26, Issue 4, Pages e669 - e678

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Mairéad McNamara

Supported by

Experimental Cancer Medicine Centre (ECMC)
National Cancer Research Institute (NCRI)
Nucana BioMed Limited
Manchester Academic Health Science Centre Trials co-ordination unit (MAHSC-CTU)
The Christie NHS Foundation Trust

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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