Could a painkiller boost immunotherapy in liver cancer?
NCT ID NCT07174570
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether adding celecoxib (a painkiller) to two immunotherapy drugs (durvalumab and tremelimumab) can help control advanced or metastatic liver cancer. About 39 adults with liver cancer that has spread will receive the combination. The goal is to see if it slows cancer growth better than immunotherapy alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- celecoxib, durvalumab, tremelimumab
- What this could lead to
- If it works, this could point toward a new combination treatment that helps control advanced liver cancer for longer.
- What could go wrong
- This is a small, early-phase trial with only 39 participants, so results may not apply to everyone. The combination may cause side effects or not improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory Saint Joseph's Hospital
RECRUITINGAtlanta, Georgia, 30342, United States
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Emory University Hospital Midtown
RECRUITINGAtlanta, Georgia, 30308, United States
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Emory University Hospital/Winship Cancer Institute
RECRUITINGAtlanta, Georgia, 30322, United States
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Grady Health System
NOT_YET_RECRUITINGAtlanta, Georgia, 30303, United States
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Other studies related to the condition(s) this trial covers.
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- Can an IDO1 inhibitor boost immunotherapy against liver cancer?
- 3D MRI scan may predict liver cancer treatment success
- New scan could spot hidden cancer left behind after liver surgery
- 3D liver stiffness scan could predict surgery risks
- Immunotherapy drug durvalumab may be safe for liver cancer patients with active hepatitis b