Testing Celecoxib Combined With Durvalumab and Tremelimumab for Treating Advanced or Metastatic Liver Cancer

What this Trial Is About

Researchers are evaluating the combination of celecoxib with durvalumab and tremelimumab in patients with advanced or metastatic hepatocellular carcinoma, a type of liver cancer that has spread to nearby tissues, lymph nodes, or distant parts of the body. This phase II trial aims to assess the effectiveness, activity, safety, and feasibility of this combination treatment, as well as explore biomarkers linked to its efficacy. Participants receive celecoxib by mouth twice daily on days 1 to 28 of each 28-day cycle. Durvalumab is given intravenously on day 1 of each cycle, and tremelimumab is given intravenously on day 1 of the first cycle only. Treatment cycles repeat every 28 days unless the disease progresses or unacceptable side effects occur. During the study, patients undergo blood sample collection, computed tomography CT or magnetic resonance imaging MRI, and may have a tissue biopsy during screening. After completing the study treatment, participants are followed up at 30 days and then every 12 weeks for up to 2 years. Researchers monitor progression-free survival, adverse events, and treatment response during this time. The study involves scheduled visits, laboratory tests, imaging scans, and evaluations to assess treatment impact and safety throughout the trial period.

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