Study on Celecoxib, Durvalumab, and Tremelimumab for Treating Advanced or Metastatic Liver Cancer

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07174570

Provider View

This clinical trial is exploring a new treatment combination using celecoxib, durvalumab, and tremelimumab to see if it can help control advanced or metastatic liver cancer. The study aims to determine the effectiveness and safety of this combination therapy.

Patient Parameters

Program Overview

This study is testing a combination of three drugs—celecoxib, durvalumab, and tremelimumab—to see if they can work together to treat liver cancer that has spread or is advanced. Celecoxib is a pain reliever that may also help stop cancer cells from growing. Durvalumab and tremelimumab are immunotherapy drugs that help the immune system attack cancer cells. The goal is to find out if this combination can better treat liver cancer that has spread or is advanced.

Description

The main goal of this study is to see how well the combination of celecoxib, durvalumab, and tremelimumab works in treating advanced liver cancer. Researchers also want to understand how safe this treatment is and how it affects the body.

Participants will take celecoxib by mouth twice a day and receive durvalumab and tremelimumab through an IV. The treatment cycles repeat every 28 days unless the cancer progresses or side effects become too severe. Throughout the study, participants will have regular blood tests and scans to monitor their health and the cancer's response to the treatment. Some participants may also have a tissue biopsy before starting the treatment.

After finishing the treatment, participants will have follow-up visits 30 days later and then every 12 weeks for up to two years to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of liver cancer and plan to receive treatment at specific cancer centers.
  • Have cancer that can be measured by scans.
  • Be 18 years or older.
  • Be in relatively good health, able to perform daily activities with some limitations.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing age must have a negative pregnancy test before starting treatment and agree to use effective birth control during the study and for three months after.
  • Have completed any previous cancer treatments at least four weeks before starting the study.
  • Have a life expectancy of more than 12 weeks.
  • Be willing to follow the study schedule and procedures, including blood tests and other evaluations.
  • Provide informed consent, understanding the nature of the study and its potential risks and benefits.

Exclusion Criteria

  • Have moderate to severe liver dysfunction.
  • Have a history of blood clots or significant bleeding events.
  • Currently use blood thinners like warfarin or heparin.
  • Have a history of stomach ulcers not adequately treated.
  • Have received immune checkpoint inhibitors within the last six months.
  • Are currently participating in another clinical trial or using investigational drugs.
  • Have allergies to similar drugs used in the study.
  • Have uncontrolled illnesses, such as infections or heart conditions, that could interfere with the study.
  • Have significant heart disease or uncontrolled high blood pressure.
  • Have conditions that make it unsafe to use NSAIDs, like certain heart or stomach issues.
  • Currently use other NSAIDs.

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