ARTEMIS is a phase II clinical trial taking place across several hospitals.
It is designed for people with moderate to high‑risk rectal cancer who are due to receive pre‑operative chemoradiotherapy (CRT) or total neoadjuvant treatment (TNT) and may be suitable for organ-preserving treatment, meaning avoiding surgery if possible.

ARTEMIS aims to find out whether adding a new immunotherapy drug called AN0025 to standard radiotherapy and chemotherapy can improve outcomes for patients, without causing unacceptable side effects.

Rectal cancer is commonly treated with one of two radiotherapy approaches:

• Short‑course radiotherapy (SCRT):
  Treatment is given over 1 week (5 sessions), usually followed by surgery.

• Long‑course chemoradiotherapy (LCCRT):
  Treatment is given over 5 weeks, sometimes with the aim of avoiding surgery if the tumour responds well.

Participants will be randomly assigned (like flipping a coin) to one of two groups:

1. Standard treatment:

   • SCRT or LCCRT (chosen by your clinical team)
   • Followed by standard chemotherapy (either FOLFOX or CAPOX)

2. Standard treatment plus the new drug (AN0025):

   • The same SCRT or LCCRT
   • The same chemotherapy (FOLFOX or CAPOX)
   • Plus AN0025, taken as a tablet once a day (500 mg), every day

Chemotherapy as part of total neoadjuvant treatment (TNT) is optional and will be decided by your clinical team in either group.

The study will assess whether adding AN0025 to standard radiotherapy and chemotherapy:

• improves how well the cancer responds
• helps achieve organ preservation
• keeps side effects at acceptable levels