Celecoxib, Durvalumab, and Tremelimumab for Advanced Liver Cancer
This study is testing a combination of three medicines – celecoxib, durvalumab, and tremelimumab – for people with advanced or metastatic liver cancer (hepatocellular carcinoma). Celecoxib is a drug that helps reduce pain and may slow tumor growth. Durvalumab and tremelimumab are immunotherapies, which work by helping your body's immune system fight cancer. The study aims to see how well this combination works to stop cancer from growing or spreading. We are looking for about 39 participants aged 18 and older who have liver cancer that has spread or is advanced. The main goal is to measure how long people live without their cancer getting worse.
- Study design
- This is a Phase II interventional study, meaning it tests how well a new treatment works. It plans to enroll 39 participants.
- What's involved
- You would take celecoxib by mouth twice daily, and receive durvalumab and tremelimumab intravenously (through a vein) on specific days of each 28-day cycle. You will also have blood samples taken and undergo CT scans.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you will have follow-up appointments at 30 days, and then every 12 weeks for up to 2 years.
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NCT07174570
Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentEmory UniversityInvestigator-initiated
~39 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:CelecoxibDurvalumabTremelimumabBiospecimen CollectionComputed TomographyMagnetic Resonance Imaging
At a glance
Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS)
Measured over Time between the date of registration and the first date of documented progression, regardless of discontinuation of study drug, or death due to any cause, whichever occurs first, assessed up to 2 years
Conditions
NCT07174570
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Emory Saint Joseph's Hospital
Atlanta, Georgiastudy coordinator listed
Recruiting
Emory University Hospital Midtown
Atlanta, Georgiastudy coordinator listed
Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgiastudy coordinator listed
Recruiting
Grady Health System
Atlanta, Georgiastudy coordinator listed
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Olumide B. Gbolahan, MBBS, MSc · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
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Eligibility criteria
Inclusion
Histologically or cytologically confirmed hepatocellular cancer (HCC) planned for treatment at gastrointestinal clinics of Emory University's Winship Cancer Institute or Grady Cancer Center
Radiologically measurable disease based on Response Evaluation Criteria in Solid Tumors version (RECIST) 1.1
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Platelet count \> 100,000 cells/ ul (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Hemoglobin (Hb) \> 9g/dl (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Absolute neutrophil count \> 1000 cells/dl (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Albumin \> 3g/dl (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Total bilirubin \< 3mg/dl (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Glomerular filtration rate (GFR) \> 60ml/min (based on creatine, and cystatin C estimation where applicable) (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Females of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
FCBP and men treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 3 months after completion of study drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Completion of all previous cancer directed therapy (including, radiotherapy, liver lesion ablation, bland or chemoembolization and transarterial radioembolization therapy) ≥ 4 weeks before the start of study therapy.
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class IIB or better.
Patients without existing cardiac disease that could raise the risk of complications who consent for the trial will proceed with trial participation
Patients with existing cardiac disease that could raise the risk of complications will be referred at the discretion of the investigator to a cardio-oncologist or general cardiologist for cardiac optimization prior to starting celecoxib
Life expectancy \> 12 weeks as determined by the investigator
Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions. This includes willingness to undergo mandatory blood sample draws for evaluation of correlatives
Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
Exclusion
Mild to moderate liver dysfunction evidenced by Child Pugh score 7B and above
History of arterial or venous thromboembolic events or gastrointestinal bleeding event. Subjects with portal venous thrombosis are permitted in the study if their treating oncologist does not deem it necessary to treat this with heparin products or direct acting anticoagulant (DOAC)
Current use of warfarin, heparin products and DOACs
Subjects with a history of (non-bleeding) peptic ulcer disease who have been on a proton pump inhibitor for less than 30 days prior to screening visit
Patients who have had immune checkpoint inhibitors (ICI) therapy within 6 months prior to entering the study or those who have not recovered from adverse events due to liver directed therapy administered more than 4 weeks earlier (i.e., have residual toxicities \> grade 2)
Patients who are receiving any other investigational agents or an investigational device within 28 days before administration of first dose of study drugs
History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study
Contraindication to ICI per investigator discretion
Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled grade ≥ 3 hypertension (diastolic blood pressure ≥ 100 mmHg or systolic blood pressure ≥ 160 mmHg) despite antihypertensive therapy
Contraindication to non-steroidal anti-inflammatory drugs (NSAIDs): cardiac conditions that significantly raise the risk of cardiopulmonary complications, including unstable angina, uncontrolled heart failure, recent gastrointestinal (GI) bleed. Note that patients who are stable on low dose aspirin (\< 325mg/day) only will be allowed on study
Current use of other NSAIDs.
What this trial measures
- Progression-Free Survival (PFS)Time between the date of registration and the first date of documented progression, regardless of discontinuation of study drug, or death due to any cause, whichever occurs first, assessed up to 2 years
PFS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated using the Brookmeyer-Crowley approach.