Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
This phase II trial tests how well the combination of celecoxib with durvalaumab and tremellimumab works in treating patients with hepatocellular cancer (liver cancer) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Celecoxib belongs to the family of drugs called nonsteroidal anti-inflammatory agents and is used to reduces pain. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving celecoxib with durvalaumab and tremellimumab may better treat patients with advanced or metastatic liver cancer.
Sponsor: Emory University
You may qualify if…
- ✓ 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)
You may not qualify if…
- ✕ 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
Where it's recruiting
Atlanta
Source: ClinicalTrials.gov · NCT07174570 · last updated 2026-01-28