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Advanced Hepatocellular CarcinomaPhase 2NCT07174570

Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer

A Phase 2 study testing Celecoxib, Durvalumab and Tremelimumab in people with Advanced Hepatocellular Carcinoma and Metastatic Hepatocellular Carcinoma, run by Emory University at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Celecoxib, Durvalumab and Tremelimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
4 sitesUnited States
Study dates
2 Jan 2026to 13 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Olumide B. Gbolahan, MBBS, MSc contact

404-778-1900

ogbolah@emory.edu

United States4 sites, 4 recruiting

  • Grady Health System

    Atlanta, Georgia, 30303

    Kathleen Coleman, 404-251-1278, kathleen.marie.coleman@emory.edu

    Olumide B. Gbolahan,, MBBS, MSc

    Not yet recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Kathleen Coleman, 404-251-1278, kathleen.marie.coleman@emory.edu

    Olumide B. Gbolahan, MBBS, MSc

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Kathleen Coleman, 404-251-1278, kathleen.marie.coleman@emory.edu

    Olumide B. B. Gbolahan, MBBS, MSc

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Kathleen Coleman, 404-251-1278, kathleen.marie.coleman@emory.edu

    Olumide B. Gbolahan, MBBS, MSc

    Recruiting

Other trials in United States

About this study

Official title: Repurposing Celecoxib to Overcome Resistance to Immunotherapy in Advanced HCC (RECON 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the efficacy of the combination of celecoxib, and durvalumab+ tremelimumab in advanced hepatocellular carcinoma (HCC).

SECONDARY OBJECTIVES:

  1. To evaluate the activity of the combination of celecoxib, and durvalumab+ tremelimumab in advanced HCC.

II. To evaluate the safety and feasibility of the combination of celecoxib, and durvalumab+ tremelimumab in advanced HCC.

TERTIARY/EXPLORATORY:

  1. To evaluate biomarkers associated with the efficacy of the combination of celecoxib, and durvalumab+ tremelimumab in advanced HCC.

OUTLINE:

Patients receive celecoxib orally (PO) twice daily (BID) on days 1-28 of each cycle, durvalumab intravenously (IV) over 30-60 minutes on day 1 of each cycle and tremelimumab IV over 30-60 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, computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study. Patients may undergo tissue biopsy during screening.

After completion of study treatment, patients are followed up at 30 days, and then every 12 weeks for up to 2 years.

Being tested
Celecoxib, Durvalumab, Tremelimumab, Biospecimen Collection, Computed Tomography
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CelecoxibDrug

    Also called , Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-,, Celecoxib, celecoxib, Elyxyb, Onsenal, SC-58635, YM 177, Celebrex, Celecoxib, CELECOXIB, CELECOXIB, 169590-42-5, 4-(5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

    Receive by mouth (PO).

  • DurvalumabBiological

    Also called Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI 4736, MEDI-4736, MEDI4736, 1428935-60-7, DURVALUMAB, Durvalumab, Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain)

    Receive intravenously (IV).

  • TremelimumabBiological

    Also called CP675206, Imjudo, Immunoglobulin G2, Anti-(Human CTLA-4 (Antigen)) (Human Monoclonal CP-675206 Clone 11.2.1 Heavy Chain) Disulfide with, 745013-59-6, Anti-CTLA4 Human Monoclonal Antibody CP-675,206, CP 675, CP 675206, CP-675, CP-675,206, CP-675206, CP675,

    Given intravenously (IV).

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computed Tomography,Computed Tomography, Computerized axial tomography, Computerized Axial Tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT SCAN, CT scan, Diagnostic CAT Scan Service Type, tomography

    Undergo Computed Tomography (CT).

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging, MR, MR Imaging, MRI Scan, MRI, NMR Imaging, NMRI, nuclear magnetic resonance imaging,, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

    Undergo Magnetic Resonance Imaging (MRI).

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY, Biopsy, Biopsy, Biopsy, biopsy, Biopsy, Biopsy, Biopsy, Biopsy, Biopsy, BIOPSY_TYPE, BIOPSY_TYPE, BIOPSY_TYPE, Bx

    Undergo tissue biopsy.

Study groups in NCT07174570
Study groupRoleWhat they receive
Treatment (celecoxib, durvalumab, tremelimumab)ExperimentalPatients 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.
Receives: Drug: Celecoxib; Biological: Durvalumab; Biological: Tremelimumab; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biopsy Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    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.

    Measured: 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

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    ORR defined as the proportion of all subjects whose best overall response is either a complete response or partial response per Response Evaluation Criteria in Solid Tumors version 1.1 criteria. ORR will be reported as a proportion, and 95% exact binomial confidence interval will be estimated using the Clopper-Pearson method.

    Measured: Up to 2 years

  2. Incidence of Adverse Events (AE)

    Will be determined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5. Frequencies and percentages will be used to summarize safety events.

    Measured: Up to 2 years

  3. One Treatment Cycle

    Frequencies and percentages will be used to determine the proportion of subjects who complete one treatment cycle.

    Measured: During cycle 1 (cycle 1 = 28 days)

  4. Incidence of Adverse Events Profile

    Incidence of Adverse Events (AE) profile with the combination of celecoxib, and durvalumab+ tremelumumab will be determined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5. Frequencies and percentages will be used to summarize events.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start2 Jan 2026
  3. Primary completion13 Nov 2026 (estimated)
  4. Study completion13 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07174570
Sponsor's protocol ID
STUDY00008622
Other IDs
P30CA138292, NCI-2025-06192, WINSHIP6414-24
Status last verified
Jan 2026
First submitted
11 Sep 2025
Last updated
28 Jan 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Celecoxib, Durvalumab and Tremelimumab in people with Advanced Hepatocellular Carcinoma and Metastatic Hepatocellular Carcinoma, run by Emory University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olumide B. Gbolahan, MBBS, MSc (404-778-1900, ogbolah@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07174570.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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