Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03937830
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • durvalumab — DRUG
    1,150 mg flat dose every 21 days, starting on day 1 of cycle 1
  • Doxorubicin-Eluting Beads — DRUG
    used for TACE (only in patients with HCC BCLC stage B)
  • TACE — PROCEDURE
    TACE with Doxorubicin-Eluting Beads (only in patients with HCC BCLC stage B) on Cycle 2. More TACE can be done if clinically necessary.
  • bevacizumab — DRUG
    7.5 mg/kg dose every 21 days, starting on day 1 of cycle 2
  • Tremelimumab — DRUG
    300, 150 or 75 mg once on day 1 of cycle 1

Study Details

Background: Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Most people with advanced HCC survive an average of 6 to 9 months. Researchers are evaluating a combination of treatment drugs to delay the progression of HCC; aiming to help people with HCC live longer. Objective: To study the 6-month progression-free survival in people with advanced HCC treated with bevacizumab, durvalumab, and TACE. Eligibility: Adults ages 18 and older with intermediate or advanced HCC Design: Participants will be screened with a physical exam and medical history. They will have tests to evaluate their hearts as well as blood and urine. A CT and/or MRI scans will be done during the study. If a prior tumor sample is not available; participants may undergo a biopsy. They may undergo an endoscopy of their esophagus and stomach. Participants will get the study drugs in 21-day cycles: Two treatment drugs will be injected into a vein every 3 weeks. Patients will have an interventional treatment procedure done by interventional radiology under sedation; chemotherapy beads will be infused into artery branches in the liver. Participants may have to stay in the hospital for 24 hours for observation, after this procedure. This interventional procedure may be done more than once during the study. Participants may need to repeat some of the screening tests throughout the study. Participants may have to stop taking some of their cancer treatment drugs during the study. Participants will continue on the study until their cancer progresses or until the side effects of the treatment drugs are not tolerable.

Key Dates

Start date
Mar 10, 2021
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
27 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1/Arm 1
    Durvalumab, bevacizumab and tremelimumab
  • Experimental: 2/Arm 2
    Durvalumab, bevacizumab, tremelimumab and TACE
  • Experimental: 3/Arm 3
    Durvalumab, low-dose bevacizumab, and tremelimumab

Primary Outcome Measure

To evaluate the 6-month progression free survival (PFS) in participants with advanced HCC BCLC stage B treated with bevacizumab, durvalumab, tremelimumab and TACE [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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