Effects of Neoadjuvant Immunotherapy on Anti-tumour Immunity in Hepatocellular Carcinoma Patients… (NCT07461675) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Effects of Neoadjuvant Immunotherapy on Anti-tumour Immunity in Hepatocellular Carcinoma Patients Undergoing Liver Resection
Switzerland30 participantsStarted 2026-03-25
Plain-language summary
Our study aims to evaluate the benefit of the administration of immunotherapy (atezolizumab), in patients with hepatocellular carcinoma (HCC), prior surgical resection of the tumor.
HCC is the most prevalent primary liver cancer, responsible for nearly 800,000 deaths annually, making it the third leading cause of cancer-related mortality worldwide. Ablation by radiologic micro-waves or surgical resection represent at the moment the only curative therapies for early stages of the disease. Despite these curative options, HCC recurrence is frequent.
Recently, immunotherapy has demonstrated good results on patient overall survival for advanced stages of HCC in comparison to sorafenib. Because of the beneficial effect of immunotherapy on HCC, several groups have attempt to use it as adjuvant therapy in order to reduce the recurrence rate. However the results are at the moment controversial. One can hypothetize that postoperative inflammation and liver regeneration can negatively impact the effect of the immunotherapy. Therefore, the administration of the treatmeent before surgical resection could overcome this issue.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All adult patients undergoing liver resection for HCC at the Geneva University Hospitals (HUG), with prior informed and signed consent.
* Patients of childbearing age must be willing to use a contraception at the day of inclusion and for at least 5 months after the last infusion.
* Negative pregnancy test at inclusion
* Patients will require to be eligible for surgical resection according to the BCLC guidelines (very early to early stage with preserved liver function and good patient condition) (4).
* The control group will include data from the patients in our ongoing research project (study protocol 2023-02372), undergoing liver resection without prior ICI therapy (n = 30).
Exclusion Criteria:
* Patients who do not ultimately undergo liver resection due to unforeseen reasons (this happens rarely, such as in the presence of unexpected HCC progression discovered during surgery).
* Patients with an ongoing pregnancy (an unlikely event, as non-surgical HCC treatments would be prioritized in such cases).
* Patients unable to follow procedures due to language barriers, insufficient comprehension of project language, or unable to give consent.
* Patients \<18 years.
* Patients with medical history of allergy or severe AEs to ICI therapy
* Pregnant and/or breastfeeding women. Lactating women should stop lactation or will be excluded from the study as breastfeeding under atezolizumab is not recommended. Furthermore, breastfeeding is not recommended for at le…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in frequency of flow cytometry-assessed HCC-specific CD8+ cells in the periphery (PBMC) between patients with vs without ICI therapy prior to liver surgery