Effects of Neoadjuvant Immunotherapy on Anti-tumour Immunity in Hepatocellular Carcinoma Patients Undergoing Liver Resection
- Sponsor
- University of Geneva, Switzerland
- Study ID
- NCT07461675
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Hepato Cellular Carcinoma (HCC)
- Immunotherapy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Atezolizumab — DRUGPatients will receive two doses of atzolizumab 6 and 3 weeks before surgery
Study Details
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.
Key Dates
- Start date
- Mar 25, 2026
- Status verified
- Mar 2026
- Primary completion
- Jun 1, 2029
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Treated group. Patients receiving immunotherapy before surgical resection of their HCC
- No Intervention: Control groupPatients undergoing surgical resection for HCC without any neoadjuvant treatment
Primary Outcome Measure
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 [ Time Frame: Four years ]
Central Contacts
- Charles-Henri Wassmer, MD-PhD+41786682206
- Christian Toso, Professor+41795533673
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