Recruiting
Phase 2

Celecoxib & Durvalumab & Tremelimumab

Sponsor:

Emory University

Code:

NCT07174570

Conditions

Advanced Hepatocellular Carcinoma

Metastatic Hepatocellular Carcinoma

Stage III Hepatocellular Carcinoma AJCC v8

Stage IV Hepatocellular Carcinoma AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Celecoxib

Durvalumab

Tremelimumab

Biospecimen Collection

Computed Tomography

Study Details

Brief summary:

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

Advanced Hepatocellular Carcinoma

Metastatic Hepatocellular Carcinoma

Stage III Hepatocellular Carcinoma AJCC v8

Stage IV Hepatocellular Carcinoma AJCC v8

Study ID

NCT07174570

Start date

Jan 2, 2026

Status verified date

Jan, 2026

Completion date

Nov 13, 2027

Anticipated

Primary completion date

Nov 13, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

\* A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • 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 Criteria:

  • 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.

Study Design

Enrollment

39 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (celecoxib, durvalumab, tremelimumab)

Patients receive celecoxib PO BID on days 1-28 of each cycle, durvalumab IV over 30 minutes on day 1 of each cycle and tremelimumab IV over 30 minutes on day 1 of cycle 1 only. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, CT or MRI throughout the study. Patients may undergo tissue biopsy during screening.

Interventions

Celecoxib

Receive by mouth (PO).

Durvalumab

Receive intravenously (IV).

Tremelimumab

Given intravenously (IV).

Biospecimen Collection

Undergo blood sample collection

Computed Tomography

Undergo Computed Tomography (CT).

Magnetic Resonance Imaging

Undergo Magnetic Resonance Imaging (MRI).

Biopsy Procedure

Undergo tissue biopsy.

Primary outcome measure

  • Progression-Free Survival (PFS) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Olumide B. Gbolahan, MBBS, MSc

404-778-1900ogbolah@emory.edu

Locations

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Kathleen Coleman

404-251-1278kathleen.marie.coleman@emory.edu

Principal Investigator:

Olumide B. Gbolahan, MBBS, MSc

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Kathleen Coleman

404-251-1278kathleen.marie.coleman@emory.edu

Principal Investigator:

Olumide B. B. Gbolahan, MBBS, MSc

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Kathleen Coleman

404-251-1278kathleen.marie.coleman@emory.edu

Principal Investigator:

Olumide B. Gbolahan, MBBS, MSc

More Information

Sponsor

Emory University

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-01-28.