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New treatment option for Advanced Hepatocellular Carcinoma
Official title Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer
ClinicalTrials.gov ID: NCT07174570
What this study is testing
What is Celecoxib?
Celecoxib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced hepatocellular carcinoma.
Also referred to as , Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-,, Celecoxib, celecoxib, Elyxyb, Onsenal, SC-58635, YM 177.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed hepatocellular cancer (HCC) planned for treatment at gastrointestinal clinics of Emory University's Winship...
- 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)
You likely can't join if
- Mild to moderate liver dysfunction evidenced by Child Pugh score 7B and above
- History of arterial or venous thromboembolic events or gastrointestinal bleeding event. people with portal venous thrombosis are permitted in the...
- Current use of warfarin, heparin products and DOACs
- people 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...
- Patients who are receiving any other investigational agents or an investigational device within 28 days before administration of first dose of study...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- Mild to moderate liver dysfunction evidenced by Child Pugh score 7B and above
- History of arterial or venous thromboembolic events or gastrointestinal bleeding event. people with portal venous thrombosis are permitted in the study if their treating oncologist does not deem it necessary to treat...
- Current use of warfarin, heparin products and DOACs
- people 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...
- 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...
- Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic...
- 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...
- Current use of other NSAIDs.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.