Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab, and TACE for Liver and Biliary Tract Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03937830

Provider View

This study is testing a combination of treatments, including immunotherapy and a procedure called TACE, to see if they can help control liver and biliary tract cancers. The goal is to find out if these treatments can help patients live longer without their cancer getting worse.

Patient Parameters

Program Overview

Hepatocellular carcinoma (HCC) is a common type of liver cancer, and biliary tract carcinoma (BTC) affects the bile ducts. This study is exploring a combination of drugs and a procedure called TACE to see if they can help control these cancers. The main goal is to see if patients with advanced HCC can live for at least six months without their cancer getting worse when treated with bevacizumab, durvalumab, and TACE. Adults aged 18 and older with intermediate or advanced HCC can participate.

Description

This study is testing a new combination of treatments for liver and biliary tract cancers. The treatments include:

  • Durvalumab: An immunotherapy drug that helps the immune system attack cancer cells.
  • Bevacizumab: A drug that stops the growth of new blood vessels that tumors need to grow.
  • Tremelimumab: Another immunotherapy drug that helps activate the immune system.
  • TACE (Transarterial Chemoembolization): A procedure that delivers chemotherapy directly to the liver tumors.

The study aims to see if these treatments can help patients with advanced liver cancer live longer without their cancer getting worse. Participants will receive the drugs in cycles, with two drugs given through an IV every three weeks. They will also undergo the TACE procedure, which may require a short hospital stay. The study will continue until the cancer progresses or the side effects become too severe.

Participants will have regular check-ups, including scans and blood tests, to monitor their health and the cancer's response to treatment. They may need to stop some cancer medications during the study.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with confirmed liver or biliary tract cancer.
  • Cancer that cannot be removed by surgery or treated with other local therapies.
  • At least one tumor that can be measured by scans.
  • Willing to undergo biopsies before and after treatment.
  • Good overall health with a performance status of 0 or 1.
  • Normal organ and blood function as determined by specific tests.
  • Willing to use effective birth control during the study and for 90 days after the last treatment.
  • Body weight over 30 kg.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Recent cancer treatments or major surgery within a specified time before starting the study.
  • Active brain metastases or certain other serious medical conditions.
  • Need for chronic steroid or immunosuppressive therapy.
  • Recent bleeding events or uncontrolled high blood pressure.
  • History of severe allergic reactions to similar drugs.
  • Pregnant or breastfeeding women.
  • HIV-positive individuals due to increased risk of complications.
  • Other serious health conditions that could interfere with the study.

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