Study on Maintenance Treatment with Zanzalintinib and Durvalumab for Advanced Liver Cancer

Sponsor: Amit Mahipal

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07226063

Provider View

This clinical trial is for people with advanced liver cancer who have been treated with tremelimumab and durvalumab. Participants will continue receiving durvalumab and start taking a new drug called zanzalintinib to see if it helps them live longer. Zanzalintinib is still being studied and is not yet approved by the FDA for liver cancer.

Patient Parameters

Program Overview

This study is for patients with advanced liver cancer who have already been treated with tremelimumab and durvalumab. Participants will continue to receive durvalumab and will also start taking zanzalintinib, an investigational drug not yet approved by the FDA. The goal is to see if this combination can help patients live longer. Durvalumab is already approved for advanced liver cancer, but zanzalintinib is still being researched.

Description

Liver cancer, specifically hepatocellular carcinoma (HCC), is a leading cause of cancer-related deaths worldwide. In 2020, there were over 900,000 new cases and about 830,000 deaths. While surgery and liver transplants can cure early-stage liver cancer, most people are diagnosed at an advanced stage where these options are not possible. For advanced liver cancer, treatments that affect the whole body are used, but survival is often less than two years. Zanzalintinib is a new oral drug that targets proteins helping cancer cells grow. It has shown promise against liver cancer cells. Researchers believe that combining zanzalintinib with durvalumab may help people with advanced liver cancer live longer.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed advanced liver cancer that cannot be removed by surgery and requires treatment affecting the whole body.
  • Must have been treated with tremelimumab and durvalumab and have stable disease or a positive response to this therapy.
  • Must have received 2 to 5 doses of durvalumab before starting this study.
  • Must be 18 years or older.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have normal organ and bone marrow function based on specific lab tests.
  • Must have a Child-Pugh Score of A (5-6).
  • Must be able to understand and sign a consent form.
  • Must have at least one measurable tumor.
  • Must have recovered from any side effects of previous treatments to a certain level.
  • Must agree to use effective birth control during the study and for a specified time after the last dose of study drugs.
  • Women of childbearing potential must not be pregnant and must meet certain criteria to confirm they are not able to become pregnant.

Exclusion Criteria

  • Cannot swallow tablets or take medication through a feeding tube.
  • Cannot be receiving other experimental cancer treatments at the same time.
  • Cannot have untreated brain cancer or central nervous system disease.
  • Cannot have a history of organ or stem cell transplants.
  • Cannot have uncontrolled illnesses like infections, heart failure, or psychiatric conditions that would interfere with the study.
  • Cannot have had a stroke, heart attack, or other significant heart or blood vessel issues within 6 months before starting the study.
  • Cannot have had a blood clot in the lungs or deep veins within 3 months before starting the study.
  • Cannot have a history of heart inflammation or certain gastrointestinal disorders.
  • Cannot have active infections requiring treatment, including hepatitis B or C, or HIV unless under control.
  • Cannot have serious non-healing wounds or fractures.
  • Cannot have had previous treatment with certain cancer drugs for liver cancer.
  • Cannot have another active cancer that requires treatment.
  • Cannot have an autoimmune disease requiring treatment within the past 3 months.
  • Cannot be pregnant or breastfeeding.
  • Cannot have had recent radiation therapy or certain surgeries close to the start of the study.
  • Cannot be taking certain blood thinners or complementary medicines close to the start of the study.
  • Cannot have significant bleeding issues or tumors invading major blood vessels.
  • Cannot have certain heart or lung conditions.
  • Cannot have received a live vaccine within 30 days before starting the study.
  • Cannot have had liver-related brain issues or significant fluid buildup in the abdomen recently.
  • Cannot have had recent local cancer treatments or surgeries close to the start of the study.

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