Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma (NCT07365839) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma
United States20 participantsStarted 2026-07-01
Plain-language summary
Randomized, 2-arm, non-comparative, pilot study assessing the efficacy of cemiplimab with or without fianlimab after treatment with yttrium-90 (Y90).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of hepatocellular carcinoma (HCC) in the liver by radiographic imaging or histology
* Eligible for yttrium-90 (Y90) treatment by the following definition:
Patients must have lung dose threshold for Y90 glass microspheres of 30 Gy (≤ 30 Gy per treatment for glass) and an estimated future liver remnant volume (FLRV) ≥ 30% of whole liver volume
* Age ≥18 years
* Disease in the liver measurable by modified Response Evaluation Criteria in Solid Tumors (mRECIST)
* Child Pugh Scale Score A-B7
* Not eligible for (according to the practice of the treating institution) or declined the following treatments:
* surgical resection
* immediate liver transplantation
* thermal ablation
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Troponin (TnT and TnI) ≤1 × upper limit of normal (ULN) at baseline Note: Patients with TnT or TnI levels between \>1 to 2 × ULN are permitted if repeat levels within 24 hours are ≤1 × ULN. If TnT or TnI levels are \>1 to 2 × ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest.
* Alkaline phosphatase ≤5 × ULN
* Aspartate aminotransferase (AST) ≤5 × ULN
* Alanine transaminase (ALT) ≤5 × ULN
* Creatinine clearance \>30 mL/min (actual or calculated per the Cockcroft-Gault formula)
* Bilirubin ≤2 milligram/ deciliter (mg/dL) Exception: If a patient has documented Gilbert's syndrome…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess the efficacy of cemiplimab with or without fianlimab as measured by progression-free survival (PFS)
Timeframe: Baseline, 6, 12, and 18 months, then every 6 months until off study up to 5 years