Trials / Recruiting

RecruitingNCT07174570

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)

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 39 (estimated)

Sponsor: Emory University · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the efficacy of the combination of celecoxib, and durvalumab+ tremelimumab in advanced hepatocellular carcinoma (HCC). SECONDARY OBJECTIVES: I. To evaluate the activity of the combination of celecoxib, and durvalumab+ tremelimumab in advanced HCC. II. To evaluate the safety and feasibility of the combination of celecoxib, and durvalumab+ tremelimumab in advanced HCC. TERTIARY/EXPLORATORY: I. To evaluate biomarkers associated with the efficacy of the combination of celecoxib, and durvalumab+ tremelimumab in advanced HCC. OUTLINE: Patients receive celecoxib orally (PO) twice daily (BID) on days 1-28 of each cycle, durvalumab intravenously (IV) over 30-60 minutes on day 1 of each cycle and tremelimumab IV over 30-60 minutes on day 1 of cycle 1 only. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study. Patients may undergo tissue biopsy during screening. After completion of study treatment, patients are followed up at 30 days, and then every 12 weeks for up to 2 years.

Conditions

Interventions

Type	Name	Description
DRUG	Celecoxib	Receive by mouth (PO).
BIOLOGICAL	Durvalumab	Receive intravenously (IV).
BIOLOGICAL	Tremelimumab	Given intravenously (IV).
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo Computed Tomography (CT).
PROCEDURE	Magnetic Resonance Imaging	Undergo Magnetic Resonance Imaging (MRI).
PROCEDURE	Biopsy Procedure	Undergo tissue biopsy.

Timeline

Start date: 2026-01-02
Primary completion: 2026-11-13
Completion: 2027-11-13
First posted: 2025-09-16
Last updated: 2026-01-28

Locations

4 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07174570. Inclusion in this directory is not an endorsement.