The SAGITTARIUS clinical trial enrolled its first patients

The first 6 patients of the project funded by the European Union’s Horizon Europe SAGITTARIUS programme have already been recruited, marking the beginning of a clinical study that could transform colon cancer treatment globally. Within the study, SAGITTARIUS experts will use liquid biopsy, an innovative approach in precision medicine, to tailor post-surgical treatment for patients with locoregional colon cancer (high-risk stage II and operable stage III). SAGITTARIUS could help to improve the effectiveness of treatments for this type of cancer, improve the patients’ quality of life and optimize these treatments’ cost.

"The participation of the first 6 patients marks the beginning of a path that could lead to new and better treatment options for millions. This is just the first step towards results that could radically change the quality of life of colon cancer patients,” commented Silvia Marsoni (IFOM), scientific coordinator of the project, involving 7 partners in 5 European countries and a network of over 20 clinical centres in Italy, Spain and Germany.

How SAGITTARIUS can make a difference

Currently, the main treatment for patients with locoregional colon cancer is surgery to remove the tumour. However, sometimes it is not enough because the tumour may have micrometastases that are not actually removed by surgery. These micrometastases are so small that they cannot be detected by imaging, so a large part of the patients after surgery is also submitted to post-operative chemotherapy (adjuvant chemotherapy), to eliminate any residual cancer cells. However, this therapy may be unnecessary for people with cancer that does not have micrometastasis, and by not taking this treatment they could avoid its toxicity.

Liquid biopsy could play a leading role in detecting the presence of micrometastases, as demonstrated by many recent clinical studies such as the PEGASUS study. SAGITTARIUS aims to use liquid biopsy to assess the presence or absence of micrometastases after surgery to evaluate whether it can help personalise the management and therapy of patients with a high-risk stage II or operable stage III colon cancer. In fact, by analysing the characteristics of tumours in patients with colon cancer, SAGITTARIUS will personalise patients’ treatment in two ways. On the one hand, by avoiding chemotherapy in those who may not need it. On the other hand, by replacing chemotherapy with other biological and immunological treatments based on the molecular characteristics of the tumour.

In the coming months, clinical sites in Italy, Germany and Spain will include more patients in this innovative study. The first challenge of the SAGITTARIUS clinical trial is to recruit 900 patients while meeting rigorous medical criteria and the time required to complete the tests for each patient’s treatment assignment. Patients should enter the study within 2-3 weeks of surgery, which is only possible through close collaboration and coordination between surgeons and pathologists and medical oncologists at participating centers.

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