Actively Recruiting
Repurposing Celecoxib to Overcome Resistance to Immunotherapy in Advanced Hepatocellular Carcinoma
Led by Emory University · Updated on 2026-01-28
39
Participants Needed
4
Research Sites
52 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
Researchers are evaluating the combination of celecoxib with durvalumab and tremelimumab in patients with advanced or metastatic hepatocellular carcinoma, a type of liver cancer that has spread to nearby tissues, lymph nodes, or distant parts of the body. This phase II trial aims to assess the effectiveness, activity, safety, and feasibility of this combination treatment, as well as explore biomarkers linked to its efficacy. Participants receive celecoxib by mouth twice daily on days 1 to 28 of each 28-day cycle. Durvalumab is given intravenously on day 1 of each cycle, and tremelimumab is given intravenously on day 1 of the first cycle only. Treatment cycles repeat every 28 days unless the disease progresses or unacceptable side effects occur. During the study, patients undergo blood sample collection, computed tomography (CT) or magnetic resonance imaging (MRI), and may have a tissue biopsy during screening. After completing the study treatment, participants are followed up at 30 days and then every 12 weeks for up to 2 years. Researchers monitor progression-free survival, adverse events, and treatment response during this time. The study involves scheduled visits, laboratory tests, imaging scans, and evaluations to assess treatment impact and safety throughout the trial period.
CONDITIONS
Brief 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 (HCC) planned for treatment at Emory University's cancer clinics
- Measurable disease by RECIST 1.1 criteria
- 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 greater than 9 g/dl within 28 days before treatment
- Absolute neutrophil count greater than 1000 cells/dl within 28 days before treatment
- Albumin 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 contraception for females of child-bearing potential and men during and for 3 months after study
- Completed all prior cancer therapies at least 4 weeks before starting study therapy
- Cardiac function assessment showing New York Heart Association class IIB or better
- Life expectancy greater than 12 weeks
- Willingness and ability to comply with study visits, drug plan, lab tests, and procedures
- Signed informed consent acknowledging understanding of study nature and risks
You will not qualify if you...
- Moderate to severe liver dysfunction (Child Pugh score 7B or above)
- History of arterial or venous blood clots or gastrointestinal bleeding (except stable portal venous thrombosis not requiring anticoagulation)
- Current use of warfarin, heparin products, or direct oral anticoagulants
- History of non-bleeding peptic ulcer disease with less than 30 days on proton pump inhibitors before screening
- Immune checkpoint inhibitor therapy within 6 months or unresolved side effects from liver-directed therapy
- Use of other investigational drugs or devices within 28 days before study drug
- Allergic reactions to similar drugs or biologics
- Contraindications to immune checkpoint inhibitors as judged by investigator
- Uncontrolled illness including infections, severe heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Significant cardiovascular disease within 3 months before study therapy
- Contraindications to non-steroidal anti-inflammatory drugs including unstable angina, uncontrolled heart failure, recent gastrointestinal bleeding
- Current use of other NSAID medications except low dose aspirin (<325 mg/day)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial, including possible tissue biopsy.
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive celecoxib by mouth twice daily on days 1-28 of each 28-day cycle, durvalumab intravenously on day 1 of each cycle, and tremelimumab intravenously on day 1 of cycle 1 only. This repeats every 28 days until disease progression or unacceptable toxicity.
1 visit per cycle (in-person)
Duration - Up to 2 years
After completing study treatment, participants are followed up at 30 days and then every 12 weeks for up to 2 years to monitor health and outcomes.
Visits at 30 days post-treatment and then every 12 weeks
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
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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