Immunotherapy combo for liver cancer shows early promise but trial halted
NCT ID NCT03630640
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested the immunotherapy drug nivolumab (Opdivo) given before and after a procedure called electroporation for people with advanced hepatocellular carcinoma (liver cancer) that could still be treated with curative intent. The study aimed to see if adding nivolumab could reduce the chance of cancer coming back within a year. However, the trial was terminated early after enrolling 43 participants, so the full results are not available. The approach remains experimental.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nivolumab (Opdivo)
- What this could lead to
- If successful, this approach could improve local control of advanced liver cancer after electroporation, potentially reducing recurrence.
- What could go wrong
- The trial was terminated early with only 43 participants, so results are limited. Immunotherapy can cause immune-related side effects, and the combination may not improve outcomes over standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
43 people
The number who actually took part.
- Started
-
Oct 2018
- Finished
-
Aug 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 99 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hepatocellular carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hôpital Jean Verdier
Bondy, 93140, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Sparing the liver: targeted chemoembolization meets lenvatinib in liver cancer
- AI-Enhanced ultrasound aims to catch liver cancer earlier
- Can turbocharged immune cells stop liver cancer from coming back?
- Two blood markers put to the test for early liver cancer detection
- New antibody pair takes aim at advanced liver cancer in major trial
- New antibody aims to preserve immune checkpoint while fighting cancer