Immunotherapy duo before liver surgery shows promise against cancer
NCT ID NCT03682276
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This trial investigates whether giving two immunotherapy drugs, ipilimumab and nivolumab, before liver surgery can help shrink tumors in people with liver cancer (hepatocellular carcinoma). Participants receive the drugs in the weeks leading up to their planned surgery. The study focuses on safety and whether the treatment delays surgery or causes side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ipilimumab and Nivolumab (immunotherapies)
- What this could lead to
- If successful, this approach could shrink liver tumors before surgery, potentially improving long-term outcomes for patients with hepatocellular carcinoma.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply broadly. Immunotherapies can cause serious side effects, including immune system overactivation.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
33 people
The number who actually took part.
- Started
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Mar 2019
- Finished
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Mar 2026
- Lead sponsor
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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 years and older
- Sex
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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: 1. Written informed consent for the trial. 2. Aged ≥18 years 3. Confirmed diagnosis of HCC 4. Willing to provide tissue from an excisional biopsy of a tumour lesion 5. Have measurable disease by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI) defined by RECIST 1.1 criteria 6. Ineligible for liver transplantation 7. Medically fit to undergo surgery as determined by the treating medical and surgical oncology team 8. ECOG performance status 0 or 1 9. Adequate organ function 10. Overall Child-Pugh class A 11. Female patient of childbearing potential should have a negative serum pregnancy test within 24 h of her first dose of IMP 12. Women of childbearing potential must be willing to use a highly effective method of contraception for the course of the study through 5 months after the last dose of Investigational Medicinal Product (IMP). Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient. 13. Sexually active males must agree to use an adequate method of contraception starting with the first dose of IMP through 7 months after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient. Exclusion Criteria: 1. Extrahepatic metastasis 2. Prior systemic anticancer treatment for HCC, including an anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody 3. Prior orthotopic liver transplantation 4. Any major surgery within the 3 weeks prior to enrolment 5. Hepatic encephalopathy 6. Ascites that is refractory to diuretic therapy 7. Is currently receiving anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy or biologic therapy) or has participated or is participating in a study of an IMP or used an investigational device within 4 weeks of the first dose of IMP 8. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy 9. Known history of active Bacillus Tuberculosis (TB) 10. History of known hypersensitivity to any monoclonal antibody or any of their excipients 11. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer 12. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment 13. Known history of, or any evidence of active, non-infectious pneumonitis 14. Active infection requiring systemic therapy, with exceptions relating to Hepatitis B and C virus infection 15. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Principal Investigator (PI) 16. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial 17. Pregnant or breastfeeding 18. Known history of Human Immunodeficiency Virus (HIV; HIV 1/2 antibodies) 19. Received a live vaccine within 30 days of first dose of IMP administration. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
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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
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Imperial College Healthcare NHS Trust
London, Greater London, W12 0HS, United Kingdom
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