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Clinical trial aims to find a new treatment for cervical cancer

Published: 30 September 2022

Researchers have started a new clinical trial which they hope can improve the treatment of cervical cancer.

The CRAIN trial is looking at whether a new drug called tolinapant can help to destroy cancerous cells and improve outcomes for patients so that more people survive the disease for longer.

The trial is led by Peter Hoskin, Professor of Clinical Oncology at the University of Manchester and the Christie NHS Foundation Trust and is run by the team at the Cancer Research UK Southampton Clinical Trials Unit at the University of Southampton.

Around 3,200 people are diagnosed with cervical cancer in the UK each year. The current standard of care in the UK is chemoradiotherapy, but around half of patients will suffer long-term side effects from the treatment, and approximately half will see their disease come back. Sadly, over a third of patients will not survive for more than five years after diagnosis.

“One of the hallmarks of cancer cells is that they can avoid a process called apoptosis,” says Professor Hoskin. “This is the mechanism of programmed cell death that is part of all normal cells in the body and ensures that damaged or old cells are removed. But in cancerous cells, the mechanism that causes apoptosis is switched off, which means the cells can grow uncontrollably, causing a tumour.”

Tolinapant is a new drug which causes this process of apoptosis in cells.

Marina Lee, trial manager for the CRAIN trial at the Southampton Clinical Trials Unit, says “Studies in the laboratory have shown that adding this drug to chemoradiotherapy can increase the number of cancer cells that are destroyed, compared to radiation alone. This early phase clinical trial will help us to find the maximum dose of tolinapant that can be safely tolerated by patients and give us an indication of whether it is effective against their cancer.”


Patient representative, Deb Smith

Deb Smith, 52, was diagnosed with cervical cancer 5 years ago. “The diagnosis came as a real shock,” says Deb. “My treatment involved having surgery and then chemotherapy. It was a very hard time. Thankfully I am now in remission and doing well, but I know that this is not the case for everyone.”

Deb is now working with the CRAIN trial team as a public research partner, acting as the patient voice in the running of the trial. “Research into cervical cancer is important to me so that as many people as possible can be successfully treated and we don’t lose people to this horrible disease. I find it incredibly exciting to be involved in the trial, quite simply because I believe this research can save lives.”

The CRAIN trial aims to recruit 42 patients at six hospitals around the UK over the next two years. It recently opened at The Christie in Manchester and is soon to open at University Hospital Southampton and several other sites around the UK.

Professor Hoskin continues: “If this first trial is successful, the hope is that it will lead to a larger trial where we can test whether the addition of tolinapant may work better than chemoradiation treatment alone and improve outcomes for people with cervical cancer in the future.”

The trial is being funded by nearly £700,000 of funding from Cancer Research UK and is supported by ASTEX Pharmaceuticals who manufacture tolinapant and are providing the drug for the trial.

Notes for editors

The CRAIN trial - A phase 1b clinical trial with dose escalation and dose expansion phases of tolinapant (ASTX660) in combination with standard radical radiotherapy in cervical cancer with chemoradiation. Read more on the CRAIN webpage.

The Southampton Clinical Trials Unit (SCTU) is a Cancer Research UK (CRUK) core-funded and National institute for Health and Care Research (NIHR) supported CTU with expertise in the design, conduct and analysis of interventional, multi-centre clinical trials. The CTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site. For more information, visit the SCTU website or follow us on Twitter and Facebook.

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The Christie:

  • The Christie is a specialist cancer centre in Manchester and has more than 120 years of expertise in cancer care, research and education. It is one of Europe’s leading cancer centres, treating over 60,000 patients a year.
  • It is the largest provider of radiotherapy in the NHS (including high energy proton beam therapy and MR guided radiotherapy); it is home to the largest chemotherapy unit in the UK; and is a specialist surgical centre concentrating on rare cancers and complex procedures.
  • The Christie is one of Europe's largest experimental cancer medicine centres and an international leader in research and development with around 650 clinical studies ongoing at any one time.
  • The Christie charity provides enhanced services for patients over and above what the NHS funds.

 Visit to find out more or follow The Christie on social media @TheChristieNHS

Cervical cancer statistics from Cancer Research UK website

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