RecruitingPhase 2NCT07174570

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

Repurposing Celecoxib to Overcome Resistance to Immunotherapy in Advanced HCC (RECON Study)


Sponsor

Emory University

Enrollment

39 participants

Start Date

Jan 2, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three drugs — celecoxib (an anti-inflammatory), durvalumab (an immunotherapy), and tremelimumab (another immunotherapy) — in people with advanced or metastatic liver cancer (hepatocellular carcinoma, or HCC). The goal is to see whether this combination can improve outcomes by combining immune activation with anti-inflammatory effects. **You may be eligible if...** - You are 18 or older with confirmed liver cancer (HCC) that is measurable on scans - You are being treated at Emory University's Winship Cancer Institute or Grady Cancer Center - You are in reasonable physical condition (ECOG 0–2) with adequate blood counts, kidney, and liver function **You may NOT be eligible if...** - You have received prior systemic treatment for advanced liver cancer - You have an active autoimmune disease - You have uncontrolled hepatitis B or C - You are allergic to celecoxib or similar anti-inflammatory drugs (NSAIDs) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCelecoxib

Receive by mouth (PO).

BIOLOGICALDurvalumab

Receive intravenously (IV).

BIOLOGICALTremelimumab

Given intravenously (IV).

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo Computed Tomography (CT).

PROCEDUREMagnetic Resonance Imaging

Undergo Magnetic Resonance Imaging (MRI).

PROCEDUREBiopsy Procedure

Undergo tissue biopsy.


Locations(4)

Grady Health System

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

View Full Details on ClinicalTrials.gov

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NCT07174570


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