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 — DRUG
    Patients 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 group
    Patients 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

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