A Study of Experimental Nivolumab For Hepatocellular Carcinoma After Surgery

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Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Hepatocellular Carcinoma, liver cancer, liver cancer surgery
Type: Biological study, Phase 3
Target:
10 Participants
Investigator:
Description
This research is being done to find out if experimental durvalumab is safe for the treatment of hepatocellular carcinoma (HCC). It will be given after surgery or ablation.

Durvalumab has been approved by the FDA as therapy for the treatment of other cancers. Both durvalumab and bevacizumab are still in the development stage for the treatment of HCC after curative resection or ablation. Neither are approved for treatment of HCC after curative resection or ablation, except for use in research studies like this.

Researchers have found that sometimes the body’s own immune system may slow down or prevent cancer growth. Sometimes though, your immune system stops working and your body is no longer able to do this.

Research has shown that cancer cells in some patients start to make signals that stop the body’s immune system from killing the cancer. One such signal is called Programmed Cell Death Ligand 1 or PD-L1 for short. New drugs like durvalumab work to stop this signal and to increase the immune response. It is hoped that by stopping this signal, the immune cells will once again be able to prevent or slow down cancer growth. Durvalumab is an antibody (a protein produced by the body’s defence system). A number of different tests will need to be done to test if durvalumab works and to learn what side effects there might be. Research has shown that some cancer cells make a protein called vascular endothelial growth factor or VEGF for short. VEGF causes the formation of blood vessels to the tumours. Research has shown that VEGF plays a role in HCC. Drugs like bevacizumab block the VEGF signal and work to stop the formation of blood vessels to the tumour
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
  • Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
  • Child-Pugh Score 5 or 6
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion criteria:

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Any evidence of tumor metastasis or co-existing malignant disease
  • Participants previously receiving any prior therapy for HCC, including loco-regional therapies
  • Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation Other protocol defined inclusion/exclusion criteria could apply
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
The length of time that you will be in the study treatment will be up to a maximum of 12 months.
Recruitment period
From July 18, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Contact
Christina Devisser
Research Topic
Conditions:
  • Hepatocellular Carcinoma
  • Liver Cancer

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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