Defeating Biliary Tract Cancer with ARTEMIDE-Biliary01
What is the ARTEMIDE-Biliary01 Clinical Trial?
The ARTEMIDE-Biliary01 clinical trial is a Phase III study designed to evaluate a new treatment called rilvegostomig, in combination with chemotherapy, for patients with biliary tract cancer (BTC) who have undergone surgical resection. This treatment aims to enhance the immune system’s ability to fight cancer cells and improve patient outcomes. The trial focuses on determining the efficacy, safety, and tolerability of this combination therapy as an adjuvant treatment to prevent cancer recurrence after surgery.
First, let’s break this down into an animated story
First, let’s break this down into an animated story

Introduction to Cell City (s)
By Professor Guzzba:
Hello again! I’m Professor Guzzba, a fictional Molecular Biologist and Scientist Character, my job is to simplify the complex into a manner that you can better understand and effectively apply.
I will now guide you through an animated explanation of this clinical trial. Firstly, let’s get you acquainted with a ‘Cell City.’ We have trillions of cell cities in our body’s universe. Cells that cluster together fire together, which simply means liver cells make liver, bile duct cells make bile ducts, and bile cells make bile, and so on. Each cell is a vibrant and bustling city within our bodies with its own specific city function, ensuring the well-being of its cluster and our body’s entire eco-universe.
Each city has a town hall (nucleus) packed with city planners and blueprints on how to run the city (genes) and their messengers (mRNA) that carry the messages to the city’s factory plants (ribosomes) that build everything the city needs to remain healthy. But sometimes, things go wrong. The genes get damaged, and the messages to the factories become chaotic, causing the factories to begin manufacturing faulty parts. This is when Cell City falls into chaos and can turn a cell rogue.
Normally, our body’s immune system steps in to help the city planners correct their mistakes, but sometimes cancer gets there first and takes over. Cancer’s first mission is to evade the immune system by stealth or false pretenses and grow its own clusters. Cancer likes to keep its tumor environment cold (cold tumors) and quiet so it can continue to grow under the radar. In some cases, the immune system does recognize and attacks the cancerous cells; this battle turns the environment into a hot tumor. Another way to understand this is that a quiet party (cold tumor) doesn’t attract attention, while a loud party (hot tumor) does. This is where every cancer story begins and the primary focus of introducing a clinical trial—to turn cold tumors hot.
Please Note: I am a fictional Molecular Biologist and Scientist Character, my job is to simplify the complex into a manner that you can better understand and effectively apply.

Meet the Main Characters: Rilvegostomig, PD-1, PD-L1, TIGIT, and Chemotherapy
By Professor Guzzba:
Rilvegostomig: Imagine Rilvegostomig as a vigilant detective in Cell City. Its job is to identify the rogue cells causing chaos. It makes these rogue cancer cells visible to the immune system, which can then target and eliminate them. Here’s how it does that:
- Blocking Immune Checkpoints: Cancer cells often use checkpoints like PD-1 and TIGIT to hide from the immune system. Rilvegostomig blocks these checkpoints, removing the cancer cells’ camouflage and allowing the immune system to recognize and attack them.
- Enhancing Antigen Presentation: Rilvegostomig makes cancer cells more visible to the immune system by encouraging the cell to present more tumor antigens (molecules) on its cell surface. Imagine it like putting up big signs on the rogue cells, making it easier for the immune system to spot and target them.
- Activating Co-stimulatory Pathways: Rilvegostomig boosts the immune response by activating additional pathways that make the immune cells more aggressive in attacking the cancer cells. Think of it as rallying the immune system troops, giving them the signal to attack more effectively.
By using these methods, Rilvegostomig helps convert cold tumors into hot tumors, making them more susceptible to immune-based therapies. This transformation helps the immune system better recognize and destroy the cancer cells, leading to more effective treatment outcomes.
PD-1: PD-1 is like a security scanner on the T cell. It’s a checkpoint protein that, when activated by PD-L1, tells the T cell to stand down. Cancer cells exploit PD-1 to hide from the immune system.
PD-L1: PD-L1 is like a Healthy City Pass on the surface of the cancer cell. When PD-L1 binds to PD-1 on the T cell, it sends a signal to the T cell to ignore the cancer cell, allowing it to evade the immune system.
TIGIT: Similar to PD-1, TIGIT is another security guard that cancer cells deceive. It’s a receptor on immune cells that, when engaged, inhibits the immune response. By blocking TIGIT, Rilvegostomig helps the immune system stay alert and active against cancer cells.
Chemotherapy: The traditional warriors in the fight against cancer, including capecitabine, gemcitabine/cisplatin, and S-1 (tegafur/oteracil/gimeracil). These agents work to kill rapidly dividing cancer cells and prevent their spread.

How ARTEMIDE-Biliary01 Works
By Professor Guzzba:
Rilvegostomig: This detective enhances the immune system’s ability to see the cancer cells. By revealing the rogue cells, the immune system can attack and destroy them more effectively, restoring order in Cell City.
Chemotherapy Combination: Working alongside Rilvegostomig, chemotherapy warriors attack the cancer cells directly. This combination aims to reduce the size of tumors and eradicate any remaining cancer cells after surgery, ensuring the city remains safe and healthy.
Key Trial Takeaways
Purpose: The ARTEMIDE-Biliary01 clinical trial aims to test the efficacy and safety of Rilvegostomig combined with chemotherapy for patients with biliary tract cancer post-surgery.
Mechanism: Rilvegostomig enhances the immune system’s ability to detect and destroy cancer cells, while chemotherapy targets and kills rapidly dividing cancer cells.
Participants: The trial is open to patients with resected biliary tract cancer who meet specific eligibility criteria.
Monitoring: Participants will be closely monitored to assess the treatment’s effects on cancer recurrence and overall survival, as well as any potential side effects.
For more information about the ARTEMIDE-Biliary01 clinical trial, please visit the ClinicalTrials.gov page for NCT06109779 or the AstraZeneca Clinical Trials page.
Recruiting Hospitals (Australia): Monash Health, Medical Oncology and Western Health – Sunshine Hospital
Key Patient Tasks
Participating in a clinical trial involves several important steps to ensure you are well-prepared and supported throughout the process. As a patient, you must discuss your research and understanding with your doctor. Below are resources that will help.
- Visit Our Trials Page
- Action: Go to our website’s dedicated clinical trials page to find detailed information about the trials we are currently conducting, including eligibility criteria, study locations, and contact information.
- Purpose: This helps you identify which trials might be suitable for you and provides essential details to discuss with your healthcare provider.
- Order Your Free Patient Navigator Journal
- Action: Request your complimentary Patient Navigator Journal, which includes a suite of digital toolkits designed to support you through your clinical trial journey.
- Purpose: The journal and toolkits offer valuable resources for tracking your health, understanding the trial process, and managing your treatment and appointments efficiently.
- Join Our Facebook Community
- Action: Become a member of our Facebook community where you can connect with other patients who are participating in the same trial.
- Purpose: This provides a platform for support, sharing experiences, and asking questions to others who are going through similar experiences. It helps build a sense of community and shared knowledge.
- Join Our Email Updates
- Action: Sign up for our email updates to receive the latest news, research findings, and updates on ongoing and upcoming clinical trials.
- Purpose: Staying informed about new developments and receiving regular updates helps you stay engaged and knowledgeable about the latest advancements in your treatment and clinical trials in general.
By completing these tasks, patients can ensure they are well-informed, prepared, and supported throughout their participation in a clinical trial. This proactive approach helps enhance their experience and contributes to the overall success of the trial.