Hepatocellular Carcinoma Clinical Trial
Official title:
A Phase I Open-label Study to Evaluate Safety and Immunologic Response of COMBIG-DC Administered Intra-tumorally in Patients With Hepatocellular Carcinoma
The primary objective of this study is to answer the question "Is it possible to inject the COMBIG-DC vaccine in a hepatic tumor without getting unacceptable side effects"?
Patients diagnosed with hepatocellular carcinoma will get COMBIG-DC vaccinations at three
occasions with 2-3 weeks and 3-5 weeks between vaccination 2 and 3 respectively. Adverse
events will be registered until 6 months after last vaccination, as well as changes in vital
signs (heart rate, blood pressure and body temperature) and lab parameters. Immunologic
response will be evaluated by measuring immunologic markers in blood. The size of the
tumor/tumors will be evaluated after 3 and 6 months and thereafter every three months until
tumor progression.
For patients included after approval of Amendment 3 (2015-12-10), COMBIG-DC will be given as
add on to standard treatment; sorafenib or Transarterial Chemoembolization (TACE).
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