Actively Recruiting
Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer
Led by Emory University · Updated on 2026-01-28
39
Participants Needed
4
Research Sites
97 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed hepatocellular cancer planned for treatment at specific gastrointestinal clinics
- Radiologically measurable disease based on RECIST version 1.1
- Age 18 years or older
- ECOG performance status 0, 1, or 2 (Karnofsky score 60% or higher)
- Platelet count greater than 100,000 cells/ul within 28 days before treatment
- Hemoglobin level greater than 9 g/dl within 28 days before treatment
- Absolute neutrophil count greater than 1000 cells/dl within 28 days before treatment
- Albumin level greater than 3 g/dl within 28 days before treatment
- Total bilirubin less than 3 mg/dl within 28 days before treatment
- Glomerular filtration rate greater than 60 ml/min within 28 days before treatment
- Negative pregnancy test for females of child-bearing potential before starting therapy
- Agreement to use adequate contraception during study participation and for 3 months after
- Completed all previous cancer therapies at least 4 weeks before starting study therapy
- Cardiac function assessed as New York Heart Association Functional Classification class IIB or better
- Life expectancy greater than 12 weeks
- Willingness and ability to comply with study visits, drug administration, tests, and procedures
- Signed informed consent acknowledging understanding of study details
You will not qualify if you...
- Mild to moderate liver dysfunction with Child Pugh score 7B or above
- History of arterial or venous thromboembolic events or gastrointestinal bleeding
- Current use of warfarin, heparin products, or direct oral anticoagulants
- History of peptic ulcer disease treated with proton pump inhibitors for less than 30 days before screening
- Immune checkpoint inhibitor therapy within 6 months prior to study or unresolved toxicities from previous liver-directed therapy
- Use of other investigational drugs or devices within 28 days before first study dose
- History of allergic reactions to similar drugs used in this study
- Contraindications to immune checkpoint inhibitors as determined by the investigator
- Uncontrolled illnesses including infections, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance
- Significant cardiovascular disease within 3 months before study start, including recent heart attack or severe heart failure
- Contraindications to non-steroidal anti-inflammatory drugs or current use of other NSAIDs except low-dose aspirin (less than 325 mg/day)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Grady Health System
Atlanta, Georgia, United States, 30303
Not Yet Recruiting
2
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
3
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
Research Team
O
Olumide B. Gbolahan, MBBS, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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