ASPIRE is a research project on liver cancer funded by the Spanish Association Against Cancer (AECC) with the participation of 26 prestigious Spanish centers. Its ultimate goal is to improve the overall survival of patients with this disease.
What is ASPIRE-AECC?
ASPIRE-AECC is a research project on liver cancer funded by the Spanish Association Against Cancer, with the participation of 25 prestigious Spanish centres. Its ultimate goal is to improve the overall survival of patients with this disease.
The project includes a clinical trial involving several hospitals. This study evaluates the impact of immunotherapy (atezolizumab and bevacizumab, drugs that help the immune system fight cancer) given before and after surgery. It is aimed at patients with liver cancer who have a high risk of tumor recurrence. The aim is to evaluate the impact of this treatment, compared with post-surgery surveillance, on delaying cancer recurrence or even preventing it after surgery.
The clinical trial: what is involved?
ASPIRE-AECC is a clinical trial designed to study if adding an immunotherapy before and after surgery can help improve outcomes in patients with liver cancer who are candidates for surgery.
The aim is to collect data on the possible clinical benefit and safety of this strategy.
If a person takes part and meets the study criteria, they will be randomly assigned to one of the two groups:
• A group that receives immunotherapy (atezolizumab and bevacizumab) before and after surgery, or.
• a group that follows standard clinical practice (surgery and subsequent follow-up).
Your participation may last between a minimum of 2 years and a maximum of 5 years..
A total of 90 patients from 14 hospitals in Spain will participate in the study.
What could participating involve?
If you want to participate, you will first receive detailed information about the study. After all your questions have been answered and you are sure you have understood what is involved, you will need to sign the informed consent. The medical team will make an initial assessment to check whether you meet the study criteria.. This assessment may include a review of your medical history, a physical examination, imaging tests, blood and urine tests, cardiology tests if necessary, an upper gastrointestinal endoscopy, and tumor biopsies.
If you are included, study follow-up may involve regular hospital visits, clinical checkups, imaging tests, blood and urine tests and post-surgery follow-up.
Who can participate?
In general terms, this study may be of interest to adults diagnosed with hepatocellular carcinoma whose tumor can be treated by surgery and who have clinical characteristics that suggest a high risk of recurrence.
It may be of interest to you if:
- You have been diagnosed with liver cancer.
- Your medical team considers you a candidate for surgery.
- The tumor has clinical characteristics that suggest an increased risk of recurrence.
However, the final decision always rests with the medical and research team.
How can I get information or ask about the study?
- • You can get information from this website or ask your doctor.
- • If you are a candidate, your medical team can guide you or refer your query to the study team.
- • The ASPIRE-AECC team will be able to answer general questions about the project and the information process.
Participating centres and access to information
ASPIRE-AECC collaborates with different hospitals and research teams in Spain.
If you want to know if this study is relevant to your case or how to get further information, you can ask your medical team or contact the project via this website.
Participating centers
Clinical (C): 15
Resources and downloadable materials:
Safety and trust
The information in this section is for guidance only.
The final decision as to whether a person can participate in the study is always the responsibility of the medical and research team, following an individual assessment and confirmation of compliance with all the criteria set out in the protocol.
The study has been approved by an Ethics Committee for Research with Medicines and by the Spanish Agency of Medicines and Medical Devices (NCT07018947) and will be conducted in accordance with current regulations, the Declaration of Helsinki and the Good Clinical Practice guidelines.
Participation is voluntary and consent can be withdrawn at any time, without affecting healthcare or the relationship with the treating physician.
Benefits and risks
- The study may contribute to improving knowledge about the treatment of hepatocellular carcinoma.
- You might not benefit directly from participating.
- The medical team will explain the potential risks and benefits individually before the decision is made.
Frequently asked questions
The aim of this study is to evaluate the impact of immunotherapy treatment before and after surgery, compared to post-surgery surveillance, on delaying cancer recurrence or even preventing it after surgery. It also aims to collect data on the possible clinical benefit and safety of this strategy.
In general terms, this study may be of interest to adults diagnosed with hepatocellular carcinoma whose tumor can be treated by surgery and who have clinical characteristics that suggest a high risk that the disease might recur. However, the final decision on participation always rests with the medical and research team.
If you wish to participate, you will first receive detailed information about the study. After all your questions have been answered and you are sure you have understood what is involved, you will need to sign the informed consent. The medical team will make an initial assessment that may include a review of your medical history, a physical examination, imaging tests, blood and urine tests, an upper gastrointestinal endoscopy, and tumor biopsies.
Yes, participation is voluntary. You can withdraw from the study at any time, if you want, without affecting your healthcare or your relationship with your doctor.
Participation in the study can last between about 2 and 5 years.
Not necessarily. This study may contribute to improving knowledge about the treatment of hepatocellular carcinoma, but participation might not directly benefit everyone. The medical team will explain the potential benefits and risks individually before you make a decision.
You can get more information via this website, from the information leaflet for patients, and from your medical team. If you need to, you can also contact the study team using the contact form.
Contact
For more information about ASPIRE-AECC, you can contact us using the contact form or the contact details provided.
