UK's first patients for Cardiff-led BICCC study

                                  Professor Rob Jones                                                            Professor Andy Godkin

04 December 2024

We are very proud to have recruited the first patients in the UK to BICCC, a new colorectal clinical trial aimed at increasing disease-free survival.

Colorectal cancer is one of the leading causes of cancer-related deaths worldwide. In the early stages of the disease, many patients can be cured with surgery. However, in the later stages, the cancer can return or progress even after surgery and chemotherapy. One potential way of preventing relapse is by making the patient’s immune system better at detecting and destroying any cancer cells that might remain after removal of the cancer.

T cells are a type of white blood cell that play a key role in the immune system. They identify and destroy infected or cancerous cells in the body by recognising specific proteins found on the cells’ surface. Previous studies have showed that T cells can recognise proteins expressed by colorectal cancer cells.

Professor Andy Godkin from Cardiff University and Cardiff and Vale UHB is leading the project. In collaboration with Velindre Oncologists he has previously shown that low dose cyclophosphamide can prime the immune system in some patients with advanced incurable colorectal cancer. Those patients seen to have a T cell response had their disease controlled for longer. At this low dose, cyclophosphamide was found to be very safe.

As cyclophosphamide kick-starts T cell response to cancer cells, we believe that this response may allow some patient’s immune system to destroy any remaining bowel cancer cells.

Professor Rob Jones, Consultant in Medical Oncology and Associate Medical Director for RD&I at Velindre University NHS Trust said:  
“We have recruited five patients to this new Cardiff-led study, the first UK site to recruit. It has been great working with Professor Andy Godkin in the past and we hope this trial will be equally as successful as our previous collaboration. Patients in the previous study tolerated treatment very well with minimal side effects. Hopefully this trial will demonstrate a brief intervention following definitive standard treatment will lead to additional patients who are cured.

Professor Andy Godkin, the Chief Investigator, Cardiff University and Cardiff and Vale University Health Board said:
“It has been a fairly long campaign to get this trial of the ground, and thanks to everyone for their patience, and for Cancer Research Wales for sticking with it. Velindre Hospital has led the way, being the first of ten centres to open, and having already recruited several patients. Heartfelt thanks to Rob Jones and all the staff at Velindre, and of course, the patients.”

Clinical trial

The Brief Intervention with Cyclophosphamide in patients with Colorectal Cancer who completed treatment (BICCC) clinical trial aims to test whether giving a low dose of cyclophosphamide for four weeks to stage 2 – 4 colorectal cancer patients who have completed surgery and chemotherapy can help improve cure rates.

This is a randomised, open-label, 2-arm study with eligible participants taking part in 10 UK centres including Cardiff and Swansea.

Participants will be recruited and randomised into one of two groups:

1. Active monitoring which is standard of care (no cyclophosphamide given) 

2. Cyclophosphamide for four weeks total spread over a nine-week period.

Recruited participants will be seen (sometimes phoned)  five times over the course of 13 weeks for monitoring and to receive their randomised treatment in the form of a tablet they take at home. The recruited participants will be followed up for three years.

The primary aim is to measure the effect of cyclophosphamide on patients’ disease-free survival.

Funding

The BICCC trial is funded by Cancer Research Wales.