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Patient Recruitment

Therapies in Patients with Hepatocellular Carcinoma or Biliary Tract Carcinoma

A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies

scientist looking at a microscope

medical illustration of a human stomach

Researchers at the National Institutes of Health (NIH) in Bethesda, Maryland are investigating if durvalumab given in combination with tremelimumab can help patients diagnosed with Hepatocellular Carcinoma (HCC) or advanced biliary tract carcinoma (BTC) that has not responded to standard treatment. The results of this study may provide answers for a new treatment that may help patients with hepatocellular carcinoma or advanced biliary tract carcinoma for which standard treatment has not helped.

All participants:

  • Will receive a biopsy of the tumor
  • Will have therapy divided into cycles, each lasting 28 days.
  • Patients will receive only Durvalumab after their 4th therapy cycle.

If you are assigned to drug treatment:

  • Patients may have tumor biopsies during cycle 2 on day 8 (day 36) and after the patient has completed cycle 3 (day 85) of tremelimumab and durvalumab.

If you are assigned to drug treatment and ablative procedure:

  • Patients on day 36 will be treated with TACE, RFA or cryoablation procedure.
  • Patients will have two additional tumor biopsies; one during TACE, RFA cryoablation procedure and an optional one after completing the third cycle (day 85).

The NIH Clinical Center is America's Research Hospital and is located in Bethesda, Maryland, on the Metro Red line (Medical Center stop).

For more information:
NIH Clinical Center Office of Patient Recruitment
800-411-1222
800-877-8339 TTY / ASCII
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Email: PRPL@cc.nih.gov

Or go online:
https://go.usa.gov/xpEKb
Refer to study # 16-C-0135

Department of Health and Human Services
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)

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This page last updated on 03/02/2020

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