A Phase 2 interventional study of Nivolumab Injection [Opdivo] in Hepatocellular Carcinoma, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
Percutaneous ablation (PA) is the only non-surgical curative treatment of hepatocellular carcinoma (HCC). Due to its excellent tolerance, particularly in patients with portal hypertension or bearing comorbidities, it now represents in France nearly 70% of the first-line curative treatment of "in Milan" tumours. For HCC less than 3 cm, ideal indication for percutaneous ablations, results of monopolar radiofrequency ablation (mRFA), are excellent with only 5% of reported non-tumoral control after a first procedure .
In addition to mRFA the arsenal of ablations has grown considerably with the emergence of new techniques. They allow the expansion of indications for PA, especially in patients with poor prognostic tumors or relatively advanced beyond the Milan criteria . In this setting, multibipolar mode using no touch technique (mbpRFAnt) increases the tumour volume that can be ablated, allowing the removal of large tumors> 5 cm . Furthermore, electroporation (EP) is a new PA technique that does not promote thermoablation but induce tumoral cells apoptosis and is particularly interesting for difficult-to-treat lesions located near vascular or biliary trunks . Inadequate tumour control is then de facto greater in these situations, around 20% at one year.
The idea of optimizing HCC curative treatments using neoadjuvant or adjuvant biotherapy, particularly in patients with advanced tumors in curative intent, is particularly attractive. One trial in adjuvant setting was conducted, the STORM trial, that tested the benefit of sorafenib in curative intent of in Milan HCC. This negative trial included patients with in Milan HCC, with an expected low rate of recurrence with only few patients treated by PA.
In parallel, the development of new molecules for HCC treatment, especially immunotherapy, seems to give promising results in palliative setting . Furthermore, PA procedures and most likely electroporation induce T-cell recruitement that may foster immunomodulation .
Neoadjuvant and adjuvant trials using these new molecules must now be cautiously designed based on the rigorous selection of special populations and therapeutic indications.
This project proposes a Phase 2 trial testing the safety and efficacy of treatment with Nivolumab in neoadjuvant and adjuvant setting in patients with advanced HCC treated by electroporation in curative intent.
Multicenter (6 centers), Phase 2 trial.
-Inclusion visit The inclusion visit takes place between 15 days and no later than 3 days before the patient's hospitalization for Neoadjuvant therapy
Eligible patients will receive :
Constitution of a biobank with :
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's enrollment of 43 is below the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with HCC eligible for EP as assessed by multidisciplinary board corresponding to the following extension:
Exclusion Criteria:
Intravenous Nivolumab 240 Q2W neoadjuvant Intravenous Nivolumab 480 mg Q4W- adjuvant for 12 months
Drug: Nivolumab Injection [Opdivo]
Intravenous Nivolumab 240 Q2W neoadjuvant Intravenous Nivolumab 480 mg Q4W- adjuvant up to 12 months after EP
Also known as: Irreversible electroporation
Local recurrence-free survival during a 1-year follow-up after Nivolumab neoadjuvant/adjuvant therapy and EP procedure
Recurrence rates (whether local or distant) will be assessed using imaging techniques as recommended by international guidelines (3-months US and MRI during two years). Patients who will meet primary endpoint will be alive 1 year after EP procedure without evidence of local recurrence on 3-months US/MRI evaluations.
Time frame: At 1 year
Changes of tumorous and non-tumorous perfusion parameters observed with CUS and MRI after one months of neoadjuvant treatments
Evaluation performed by CUS and MRI
Time frame: after one month of neoadjuvant treatment
Per nodule rates of early response
Evaluation performed by MRI
Time frame: At one month after a single procedure of EP
Incidences of intra segmental/ extra segmental distant recurrence
Evaluation performed by MRI
Time frame: During follow-up (2 yrs)
Assessment of overall survival
patients will meet this endpoint if they are alive with or without HCC recurrence 2 years after EP. procedures. Causes and date of death will be specified when applicable during this timeframe.
Time frame: At 2-yrs following EP procedure
Assessment of tolerance of the immunotherapy treatment:
Adverse events related to Nivolumab infusions will be monitored according to manufacturer guidelines and recommendation.
Time frame: During follow-up (2 yrs)
Compliance to neoadjuvant treatments
Respect of scheduled Nivolumab infusions
Time frame: During follow-up (13 months)
Compliance to adjuvant treatments
Respect of scheduled Nivolumab infusions
Time frame: During follow-up (13 months)
Frequency of SAEs
adverse events related to Nivolumab infusions will be monitored according to manufacturer guidelines and recommendation.
Time frame: During follow-up (2 yrs)
Frequency of discontinuations treatment due to AEs
adverse events related to Nivolumab infusions will be monitored according to manufacturer guidelines and recommendation.
Time frame: During follow-up (2 yrs)
Plan to share: No
This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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