48-year-old Nick Cleworth, a train driver and dad-of-one from Swinton, is free from rectal (lower bowel) cancer after taking part in a clinical trial at The Christie NHS Foundation Trust, the specialist cancer centre where he was treated.
Nick, who has been married to Louise for 20 years, went to his GP in late 2024 after noticing significant amounts of blood in his stool. He had a colonoscopy, CT scan and MRI scan, which revealed a 4cm tumour in his rectum, which he visualises as being the size of a golf ball. The cancer had also spread to a couple of nearby lymph nodes.
“My Dad was 48 when he died from bowel cancer, the same age that I am now, so I’d always been vigilant about my health. But even though it was something that I knew might happen, the diagnosis still hit me extra hard. I couldn’t help but think about my dad and what he went through,” he says. “It was a really difficult time.”
Currently, many people with rectal cancer require surgery, sometimes with radiotherapy or chemotherapy to shrink the tumour beforehand.
“I had a chat with the surgeon at my local hospital who said that because of the size and position of my tumour, he wouldn’t be able to operate without leaving me with a permanent colostomy bag and, although I was obviously willing to do anything to get rid of my cancer, it wasn’t ideal,” Nick says.
As Nick’s cancer had spread to some nearby lymph nodes, he was referred to The Christie for radiotherapy. It was there that he met his consultant, Dr Claire Arthur, who told him that he might be eligible for a trial that could avoid the need for surgery altogether.
The ARTEMIS trial is a phase II clinical trial that is investigating whether adding a brand-new investigational immunotherapy drug called palupiprant (previously known as AN0025) to standard chemotherapy and radiotherapy can successfully treat rectal cancer and avoid surgery altogether. The trial will enable researchers to find out whether this approach is better than the standard of care treatment alone.
An earlier phase 1b study of palupiprant showed that this immunotherapy was well tolerated and 36% of participants were cancer free following 6 months of treatment.
Like other immunotherapy treatments, palupiprant is thought to work by stimulating the body’s own immune response against the cancer, helping destroy cancer cells alongside the radiotherapy and chemotherapy treatments.
The trial, which is being led by the Cancer Research UK Clinical Trials Unit at the University of Leeds, has recently closed to recruitment after reaching the target of 140 patients across 22 NHS sites in the UK. Half of the patients were randomised to receive the additional immunotherapy drug alongside standard chemotherapy and radiotherapy. This allows researchers to compare outcomes clearly and ensure any benefits outweigh any additional risks of palupiprant.
Professor Mark Saunders, Consultant Clinical Oncologist at The Christie, and another member of Nick’s clinical team at The Christie, is the co-chief investigator of the ARTEMIS trial.
“I was much more positive coming out of that first meeting with Dr Arthur. She was very calm and reassuring. I left feeling like we had a plan and, more importantly, I felt hopeful for the first time since my diagnosis. She helped put me in the right mindset to tackle my treatment. Everyone at The Christie was brilliant, I can’t thank them enough.”
Nick started on his immunotherapy and chemotherapy tablets in February 2025, followed by 5 weeks of radiotherapy in March. Following this, he had a further 12 weeks of intravenous chemotherapy that started at the beginning of May. He had a scan in July, which showed he was cancer-free, and he has stayed that way ever since.
“Because of my family history, I had some preconceptions about what cancer treatment would be like. I had my immunotherapy and part of my chemotherapy as tablets at home and, although I did have some side effects, they weren’t as bad as I’d anticipated. And that’s all down to research. I would recommend a clinical trial to anyone. You are well looked after, and you could be making life better for other people like you in the future.”
“I know there’s a chance that my cancer could come back, but I’m just taking each day as it comes. I’ve got three holidays planned for this year and am living life to the full. Thanks to the trial, I didn’t have to have surgery, which meant I could get back to doing the things I love – like restoring classic cars – much more quickly. I’m so grateful for that,” Nick says.
“It’s great to see that Nick has had such a good response to the trial treatment and that he tolerated treatment well,” comments Dr Claire Arthur, Nick’s consultant clinical oncologist at The Christie. “As clinicians, our goal is to treat the cancer effectively while also giving patients the best quality of life we can. The ARTEMIS trial is a great example of that”.
“Immunotherapy has only been around for a relatively short time, but it is an exciting development. As it harnesses the body’s immune system to fight the cancer, it generally comes with different side effects than traditional chemotherapy, and we’re continuing to learn about this.
“Although ARTEMIS is still in its early stages, a smaller study involving palupiprant had previously showed some promising results. By involving more patients, we hope to be able to validate those findings and hopefully change the way rectal cancer is treated on the NHS.”
Patients and GPs interested in learning more about the trial are encouraged to contact The Christie or speak with their oncology team.
Not all patients will fit the criteria for a specific trial. While clinical trials can be successful for some patients, outcomes can vary from case to case. More information about taking part in clinical trials can be found on our taking part in studies and trials page.
About Palupiprant (AN0025)
“Palupiprant is a small molecule prostaglandin E receptor 4 (EP4) antagonist, discovered by Eisai Co., Ltd. (Eisai), designed to modulate the tumor microenvironment. Adlai Nortye has been granted exclusive rights concerning the research, development, manufacture, and marketing in all regions outside of Japan and parts of Asia (excluding China) by Eisai. It is currently under development for the treatment of locally advanced rectal cancer with radiation therapy in the ongoing global Phase II ARTEMIS study. Phase 1b results for this indication were presented at the European Society for Medical Oncology (ESMO) in October 2019, where combination therapy with palupiprant and RT/CRT was well tolerated and enabled 36% of patients to achieve either a clinical complete response (cCR) or a pathologic complete response (pCR).”