RT+ Anti-PD-1 for Patients With Advanced HCC (RT+PD-1-HCC)
Status:
Not yet recruiting
Trial end date:
2020-07-30
Target enrollment:
Participant gender:
Summary
Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to
increase in many countries in coming decades. Approximately 70-80% of newly diagnosed HCC
patients already have advanced disease. Sorafenib and lenvatinib are recommended as
first-line options for advanced HCC, the median overall survival of the patients with
advanced HCC receiving sorafenib reached 10.7 months. Based on the results of phase II
clinical studies and the recommendation of guidelines, the PD-1 monoclonal antibody, such as
nivolumab and pembrolizumab, have been approved to treat the patients with advanced HCC by
the FDA. PD-1 monoclonal antibody has been recommended as a second-line therapeutic strategy
for HCC in the 2018 CSCO guidelines for the diagnosis and treatment of primary liver cancer.
However, the results of existing studies indicate that the objective response rate (ORR) of
first-line PD-1 antibody therapy for patients with advanced liver cancer is about 20%.
There is a growing recognition of radiation-induced cancer cells-external tumor control
mechanisms, in which radiation therapy(RT) contributes not only to local control of target
lesions, but also to the control of metastases away from the treatment site. In recent years,
RT combined with immunotherapy as a new treatment method has achieved certain curative effect
in some patients with metastatic cancer. Therefore, it is interesting to investigate the
efficacy of combining radiation therapy plus systemic anti-PD-1 immunotherapy for patients
with advanced hepatocellular carcinoma.