NCT07174570 Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer
| NCT ID | NCT07174570 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Emory University |
| Condition | Advanced Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 39 participants |
| Start Date | 2026-01-02 |
| Primary Completion | 2026-11-13 |
Trial Parameters
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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.
Eligibility Criteria
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
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