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

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. 

Results 
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  in the blood
• a drop in the number of blood cells that clot the blood
• blood clots 

Conclusion
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 ) 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.