A Phase II Study to Compare YIV-906 plus Sorafenib versus Sorafenib Alone in Patients with Liver Cancer Who Also Have Hepatitis B

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Full Title

A Phase II Randomized Placebo Controlled Study Investigating The Combination Of YIV-906 And Sorafenib (Nexavar®) In HBV (+) Patients With Advanced Hepatocellular Carcinoma

Purpose

Sorafenib is a drug used to treat liver cancer. It works by blocking a protein that signals cancer cells to multiply. In this study, researchers want to see if adding the investigational drug YIV-906 to sorafenib treatment is safe and more effective than sorafenib alone in patients who have both liver cancer and hepatitis B.

YIV-906 is a traditional Chinese medicine made from four herbs. It may prevent or treat some of the severe side effects associated with cancer chemotherapy, and researchers think that it may increase the time before the cancer gets worse. Patients will be randomly assigned to receive sorafenib plus YIV-906 or sorafenib plus a placebo. Both sorafenib and YIV-906 are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced liver cancer that cannot be cured with local therapy and has never been treated with chemotherapy or immunotherapy.
  • Patients must also have hepatitis B infection.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. James Harding at 646-888-4314.

Protocol

19-447

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators