Hepatocellular CarcinomaPhase 2NIVOLEPNCT03630640
Neoadjuvant and Adjuvant Nivolumab in HCC Patients Treated by Electroporation
A Phase 2 study testing Nivolumab Injection [Opdivo] in people with Hepatocellular Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Nivolumab Injection [Opdivo]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2018to 19 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 18 years of age
- Histological diagnosis of HCC, whether new or recurrent following a prior curative therapeutic management > 6 months.
- Barcelona Clinical Liver Cancer(BCLC) stage Category A
- Patients with HCC eligible for EP as assessed by multidisciplinary board corresponding to the following extension:
- Uninodular HCC≥ 2 cm and ≤ 5 cm, no macroscopic vascular invasion
- Multinodular HCC maximum 3 nodules ≤ 3 cm, no macroscopic vascular invasion
Show all 14Show fewer
- At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified RECIST for HCC
- Liver function status Child-Pugh Class A
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Adequate bone marrow, liver and renal function
- Life expectancy ≥ 3 months
- Women of childbearing potential and men must agree to use adequate contraception
- Patients affiliated to a Social Security System
- Written informed consent signed
Who cannot join
- Patients with contraindications to EP (Pacemakers or patients who have a history of cardiac arrhythmias or irregular heartbeats, ascites, Coagulopathy, Ongoing infection)
- Patients with contraindication to contrast medium intravenous injection either gadolinium or iodinate
- Prior liver transplantation or candidates for liver transplantation
- Prior systemic treatment for HCC, in particular agents targeting T-cell costimulation or checkpoint pathways (including those targeting PD-1, PD-L1 or PD-L2, CD137, or cytotoxic T-lymphocyte antigen [CTLA-4]).
- Patients with uncontrolled HBV infection and viral load above 100 IU/mL.
- Patients with large esophageal varices at risk of bleeding that are not being treated with conventional medical intervention
Show all 26Show fewer
- Past or concurrent history of neoplasm other than HCC, except for in situ carcinoma of the cervix uteri and/or non-melanoma skin cancer and superficial bladder tumors. Any cancer curatively treated > 3 years prior to study entry is permitted
- Known history or symptomatic metastatic brain or meningeal tumors
- Major surgical procedure or significant traumatic injury within 28 days before enrolment
- Congestive heart failure New York Heart Association (NYHA) ≥ class 2
- Unstable angina or myocardial infarction within the past 6 months before enrolment
- Grade 3 (severe) hypertension ≥180 and/or ≥110 mmHG (systolic and diastolic, according to National Heart Foundation 2016)
- Patients with phaeochromocytoma
- Refractory ascites according to EASL guidelines definition (ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction and diuretic treatment)
- Persistent proteinuria of NCI-CTCAE version 4.0 ≥ Grade 3
- Ongoing infection > Grade 2 according to NCI-CTCAE version 4.0. Hepatitis B is allowed if no active replication is present (HBV replication below 100 IU/mL). Hepatitis C is allowed if no antiviral treatment is required
- Clinically significant bleeding NCI-CTCAE version 4.0 ≥ Grade 3 within 30 days before enrolment
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism within 6 months before enrolment
- Any psychological, familial, sociological, geographical or illness or medical condition that could jeopardize the safety of the patient and/or his compliance with the study protocol and follow-up procedure
- Known history of human immunodeficiency virus (HIV) infection
- Seizure disorder requiring medication
- Non-healing wound, ulcer or bone fracture
- Known hypersensitivity to the study drug or excipients in the formulation
- Any malabsorption condition
- Breast feeding
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunotherapy by Nivolumab in Neoadjuvant and Adjuvant Setting in Patients With Advanced HCC Treated by Electroporation in Curative Intent: French Multicenter Phase 2 Therapeutic Trial.
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.
Read more
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.
Read the detailed description
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 :
- 2 nivolumab infusions in a neoadjuvant setting (every 15 days) The treatment will be carried out every 2 weeks s, for 2 cycles before EP procedure The patient is hospitalized one day for treatment
- EP procedure performed in a curative attempt EP procedure will be performed according to previously described procedure in the setting of routine management of HCC as decided in multidisciplinary boards in each centre.
- 12 nivolumab infusions in an adjuvant setting (every 30 days) during one year. The patient is hospitalized one day for infusion
- Classical follow-up during an additional year (every 3 months) Follow up after adjuvant therapy (M12-M24) The usual evaluation will be performed every 3 months
Constitution of a biobank with :
- paraffin and frozen tumoral and non tumoral biopsy sampled at before and after one month of neoadjuvant Nivolumab (second biopsies at the time of the electroporation procedure)
- Serum samples and Peripheral blood mononuclear cells (PBMC) before and after one month of neoadjuvant Nivolumab then after EP at 1, 3, 6, 9 and 12 months after procedure.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Nivolumab Injection [Opdivo]
- Keywords
- nivolumab; neoadjuvant; electroporation,adjuvant
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab Injection [Opdivo]Drug
Also called Irreversible electroporation
Intravenous Nivolumab 240 Q2W neoadjuvant Intravenous Nivolumab 480 mg Q4W- adjuvant up to 12 months after EP
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab Injection [Opdivo] | Experimental | Intravenous Nivolumab 240 Q2W neoadjuvant Intravenous Nivolumab 480 mg Q4W- adjuvant for 12 months Receives: Drug: Nivolumab Injection [Opdivo] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 year
Secondary outcomes (9)
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
Measured: after one month of neoadjuvant treatment
Per nodule rates of early response
Evaluation performed by MRI
Measured: At one month after a single procedure of EP
Incidences of intra segmental/ extra segmental distant recurrence
Evaluation performed by MRI
Measured: 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.
Measured: 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.
Measured: During follow-up (2 yrs)
Compliance to neoadjuvant treatments
Respect of scheduled Nivolumab infusions
Measured: During follow-up (13 months)
Compliance to adjuvant treatments
Respect of scheduled Nivolumab infusions
Measured: During follow-up (13 months)
Frequency of SAEs
adverse events related to Nivolumab infusions will be monitored according to manufacturer guidelines and recommendation.
Measured: 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.
Measured: During follow-up (2 yrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start11 Oct 2018
- Primary completion30 Sep 2022
- Study completion19 Aug 2023
Why it stopped: Because patient recruitment was affected by the COVID-19 pandemic, the study sponsor and funding partner halted enrollment at that time to meet contractual obligations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical study phase II
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Pierre NAHON, MD,PhD, Principal investigator, APHP-Hôpital Jean Verdier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630640
- Sponsor's protocol ID
- P171001J
- Acronym
- NIVOLEP
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2018
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sutter O, Calvo J, N'Kontchou G, Nault JC, Ourabia R, Nahon P, Ganne-Carrie N, Bourcier V, Zentar N, Bouhafs F, Sellier N, Diallo A, Seror O. Safety and Efficacy of Irreversible Electroporation for the Treatment of Hepatocellular Carcinoma Not Amenable to Thermal Ablation Techniques: A Retrospective Single-Center Case Series. Radiology. 2017 Sep;284(3):877-886. doi: 10.1148/radiol.2017161413. Epub 2017 Apr 28.
PubMed 28453431Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.
PubMed 26361969El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, Kim TY, Choo SP, Trojan J, Welling TH Rd, Meyer T, Kang YK, Yeo W, Chopra A, Anderson J, Dela Cruz C, Lang L, Neely J, Tang H, Dastani HB, Melero I. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017 Jun 24;389(10088):2492-2502. doi: 10.1016/S0140-6736(17)31046-2. Epub 2017 Apr 20.
PubMed 28434648
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy by Nivolumab in Neoadjuvant and Adjuvant Setting in Patients With Advanced HCC Treated by Electroporation in Curative Intent: French Multicenter Phase 2 Therapeutic Trial.
- ClinicalTrials.gov ID
- NCT03630640
- Acronym / sponsor ID
- NIVOLEP / P171001J
- Conditions
- Hepatocellular Carcinoma
- Keywords
- nivolumab; neoadjuvant; electroporation,adjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because patient recruitment was affected by the COVID-19 pandemic, the study sponsor and funding partner halted enrollment at that time to meet contractual obligations
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 19 Aug 2023 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 :
- 2 nivolumab infusions in a neoadjuvant setting (every 15 days) The treatment will be carried out every 2 weeks s, for 2 cycles before EP procedure The patient is hospitalized one day for treatment
- EP procedure performed in a curative attempt EP procedure will be performed according to previously described procedure in the setting of routine management of HCC as decided in multidisciplinary boards in each centre.
- 12 nivolumab infusions in an adjuvant setting (every 30 days) during one year. The patient is hospitalized one day for infusion
- Classical follow-up during an additional year (every 3 months) Follow up after adjuvant therapy (M12-M24) The usual evaluation will be performed every 3 months
Constitution of a biobank with :
- paraffin and frozen tumoral and non tumoral biopsy sampled at before and after one month of neoadjuvant Nivolumab (second biopsies at the time of the electroporation procedure)
- Serum samples and Peripheral blood mononuclear cells (PBMC) before and after one month of neoadjuvant Nivolumab then after EP at 1, 3, 6, 9 and 12 months after procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical study phase II
| Arm | Type | Receives |
|---|---|---|
| Nivolumab Injection [Opdivo] | Experimental | Drug: Nivolumab Injection [Opdivo]Intravenous Nivolumab 240 Q2W neoadjuvant Intravenous Nivolumab 480 mg Q4W- adjuvant for 12 months |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female patients ≥ 18 years of age
- Histological diagnosis of HCC, whether new or recurrent following a prior curative therapeutic management > 6 months.
- Barcelona Clinical Liver Cancer(BCLC) stage Category A
- Patients with HCC eligible for EP as assessed by multidisciplinary board corresponding to the following extension:
- At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified RECIST for HCC
Key exclusion criteria (26 listed)
- Patients with contraindications to EP (Pacemakers or patients who have a history of cardiac arrhythmias or irregular heartbeats, ascites, Coagulopathy, Ongoing infection)
- Patients with contraindication to contrast medium intravenous injection either gadolinium or iodinate
- Prior liver transplantation or candidates for liver transplantation
- Prior systemic treatment for HCC, in particular agents targeting T-cell costimulation or checkpoint pathways (including those targeting PD-1, PD-L1 or PD-L2, CD137, or cytotoxic T-lymphocyte antigen [CTLA-4]).
- Patients with uncontrolled HBV infection and viral load above 100 IU/mL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab Injection [Opdivo]Also: Irreversible electroporationIntravenous Nivolumab 240 Q2W neoadjuvant Intravenous Nivolumab 480 mg Q4W- adjuvant up to 12 months after EP | Drug | Nivolumab Injection [Opdivo] |
Primary outcome
Local recurrence-free survival during a 1-year follow-up after Nivolumab neoadjuvant/adjuvant therapy and EP procedure
Time frame: At 1 year
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.
9 secondary outcomes
Changes of tumorous and non-tumorous perfusion parameters observed with CUS and MRI after one months of neoadjuvant treatments
Time frame: after one month of neoadjuvant treatment
Per nodule rates of early response
Time frame: At one month after a single procedure of EP
Incidences of intra segmental/ extra segmental distant recurrence
Time frame: During follow-up (2 yrs)
Assessment of overall survival
Time frame: At 2-yrs following EP procedure
Assessment of tolerance of the immunotherapy treatment:
Time frame: During follow-up (2 yrs)
Compliance to neoadjuvant treatments
Time frame: During follow-up (13 months)
Compliance to adjuvant treatments
Time frame: During follow-up (13 months)
Frequency of SAEs
Time frame: During follow-up (2 yrs)
Frequency of discontinuations treatment due to AEs
Time frame: During follow-up (2 yrs)
Results and safety
The study was stopped early (reason given: Because patient recruitment was affected by the COVID-19 pandemic, the study sponsor and funding partner halted enrollment at that time to meet contractual obligations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 28453431Sutter O, Calvo J, N'Kontchou G, Nault JC, Ourabia R, Nahon P, Ganne-Carrie N, Bourcier V, Zentar N, Bouhafs F, Sellier N, Diallo A, Seror O. Safety and Efficacy of Irreversible Electroporation for the Treatment of Hepatocellular Carcinoma Not Amenable to Thermal Ablation Techniques: A Retrospective Single-Center Case Series. Radiology. 2017 Sep;284(3):877-886. doi: 10.1148/radiol.2017161413. Epub 2017 Apr 28.
- Background: PubMed 26361969Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.
- Background: PubMed 28434648El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, Kim TY, Choo SP, Trojan J, Welling TH Rd, Meyer T, Kang YK, Yeo W, Chopra A, Anderson J, Dela Cruz C, Lang L, Neely J, Tang H, Dastani HB, Melero I. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017 Jun 24;389(10088):2492-2502. doi: 10.1016/S0140-6736(17)31046-2. Epub 2017 Apr 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre NAHON, MD,PhD principal investigator
APHP-Hôpital Jean Verdier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab Injection [Opdivo] in people with Hepatocellular Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Because patient recruitment was affected by the COVID-19 pandemic, the study sponsor and funding partner halted enrollment at that time to meet contractual obligations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence-free survival during a 1-year follow-up after Nivolumab neoadjuvant/adjuvant therapy and EP procedure (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630640, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.